YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 ROSA TOSCANA (OCTINOXATE) LIPSTICK YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 AMBRE (OCTINOXATE)

YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 ROSA TOSCANA (OCTINOXATE) LIPSTICK YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 AMBRE (OCTINOXATE)
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NDC 23319-0021-1, 23319-0022-1, 23319-0023-1, 23319-0024-1, 23319-0025-1, 23319-0026-1, 23319-0027-1, 23319-0028-1, 23319-0029-1, 23319-0030-1, 23319-0031-1, 23319-0032-1, 23319-0033-1, 23319-0034-1, 23319-0035-1, 23319-0036-1, 23319-0037-1, 23319-0038-1, 23319-0039-1, 23319-0040-1, 23319-0042-1, 23319-0043-1, 23319-0044-1, 23319-0045-1, 23319-0046-1, 23319-0047-1
Set ID 78eb9610-a67d-ad72-e053-2991aa0ad1da
Category HUMAN OTC DRUG LABEL
Packager Yanbal USA, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredient

    Octinoxate 4%

    Purpose: Sunscreen

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  • Use

    • helps prevent sunburn
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  • Warnings

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

    For external use only.

    Do not use on damaged or broken skin.

    Stop use and ask a doctor if rash occurs.

    Keep out of the reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply at least every 2 hours
    • children under 6 months: Ask a doctor.
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  • Other information

    • protect this product from excessive heat and direct sun
    • report serious adverse event to Report Reaction, LLC, P.O. Box 22, Plainsboro, NJ 08536-0222
    Close
  • Inactive ingredients

    ISOSTEARYL ISOSTEARATE, RICINUS COMMUNIS (CASTOR) SEED OIL, BIS-PEG-12 DIMETHICONE BEESWAX, CANDELILLA CERA / EUPHORBIA CERIFERA (CANDELILLA) WAX, POLYETHYLENE, BUTYLOCTYL SALICYLATE, HYDROGENATED POLYISOBUTENE, C10-30 CHOLESTEROL / LANOSTEROL ESTERS, HYDROGENATED POLYDECENE, BIS-DIGLYCERYL POLYACYLADIPATE-2, AQUA / WATER, POLYGLYCERYL-10 HEPTAHYDROXYSTEARATE, CERA MICROCRISTALLINA / MICROCRYSTALLINE WAX, CETYL ALCOHOL, POLYAMIDE-5, CAPRYLYL GLYCOL, TOCOPHEROL, PARFUM / FRAGRANCE, PHENOXYETHANOL, OLIVE GLYCERIDES, ISOCETYL STEAROYL STEARATE, HEXYLENE GLYCOL, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, GLYCERIN, MYRICA PUBESCENS FRUIT WAX, HEXYL CINNAMIC ALDEHYDE, BENZYL SALICYLATE, LINALOOL, CITRONELLOL, HYDROXYCITRONELLAL, GERANIOL, CERAMIDE-3, BENZYL BENZOATE, LIMONENE, BENZYL CINNAMATE, BHT, ALPHA-ISOMETHYL IONONE, SYNTHETIC FLUORPHLOGOPITE, TIN OXIDE, MICA, TITANIUM DIOXIDE (CI 77891), YELLOW 6 LAKE (CI 15985), RED 27 LAKE (CI 45410), RED 6 LAKE (CI 15850), RED 30 LAKE (CI 73360), IRON OXIDES (CI 77491), RED 7 LAKE (CI 15850), YELLOW 5 LAKE (CI 19140), RED 33 LAKE (CI 17200), MANGANESE VIOLET (CI 77742), YELLOW 10 LAKE (CI 47005), IRON OXIDES (CI 77499), IRON OXIDES (CI 77492), BLUE 1 LAKE (CI 42090), BRONZE POWDER (CI 77400), CARMINE (CI 75470), BISMUTH OXYCHLORIDE (CI 77163), RED 40 LAKE (CI 16035).

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  • Company Information

    Distributed by YANBAL USA INC. 1341 W Newport Center Dr. Deerfield Beach, FL 33442

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  • Product Packaging - Ambre

    YANBAL

    HYDRA-LIP LABIAL COLOR INTENSO

    INTENSE COLOR LIPSTICK

    SUNSCREEN SPF 15

    Net wt. 4 g 0.14 oz

    ambre

    Close
  • Product Packaging - Burdeo Night

    YANBAL

    HYDRA-LIP LABIAL COLOR INTENSO

    INTENSE COLOR LIPSTICK

    SUNSCREEN SPF 15

    Net wt. 4 g 0.14 oz

    burdeo night

    Close
  • Product Packaging - Chocolat

    YANBAL

    HYDRA-LIP LABIAL COLOR INTENSO

    INTENSE COLOR LIPSTICK

    SUNSCREEN SPF 15

    Net wt. 4 g 0.14 oz

    chocolat

    Close
  • Product Packaging - Creme Nude

    YANBAL

    HYDRA-LIP LABIAL COLOR INTENSO

    INTENSE COLOR LIPSTICK

    SUNSCREEN SPF 15

    Net wt. 4 g 0.14 oz

    creme nude

    Close
  • Product Packaging - Dusty Red

    YANBAL

    HYDRA-LIP LABIAL COLOR INTENSO

    INTENSE COLOR LIPSTICK

    SUNSCREEN SPF 15

    Net wt. 4 g 0.14 oz

    dusty red

    Close
  • Product Packaging - Guinda Etnico

    YANBAL

    HYDRA-LIP LABIAL COLOR INTENSO

    INTENSE COLOR LIPSTICK

    SUNSCREEN SPF 15

    Net wt. 4 g 0.14 oz

    guinda etnico

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  • Product Packaging - Honey Nude

    YANBAL

    HYDRA-LIP LABIAL COLOR INTENSO

    INTENSE COLOR LIPSTICK

    SUNSCREEN SPF 15

    Net wt. 4 g 0.14 oz

    honey nude

    Close
  • Product Packaging - Lady Malbec

    YANBAL

    HYDRA-LIP LABIAL COLOR INTENSO

    INTENSE COLOR LIPSTICK

    SUNSCREEN SPF 15

    Net wt. 4 g 0.14 oz

    lady malbec

    Close
  • Product Packaging - Orquidea Pink

    YANBAL

    HYDRA-LIP LABIAL COLOR INTENSO

    INTENSE COLOR LIPSTICK

    SUNSCREEN SPF 15

    Net wt. 4 g 0.14 oz

    orquidea pink

    Close
  • Product Packaging - Rosa Toscana

    YANBAL

    HYDRA-LIP LABIAL COLOR INTENSO

    INTENSE COLOR LIPSTICK

    SUNSCREEN SPF 15

    Net wt. 4 g 0.14 oz

    rosa toscana

    Close
  • Product Packaging - Sugar Pop

    YANBAL

    HYDRA-LIP LABIAL COLOR INTENSO

    INTENSE COLOR LIPSTICK

    SUNSCREEN SPF 15

    Net wt. 4 g 0.14 oz

    sugar pop

    Close
  • Product Packaging - Summer Nude

    YANBAL

    HYDRA-LIP LABIAL COLOR INTENSO

    INTENSE COLOR LIPSTICK

    SUNSCREEN SPF 15

    Net wt. 4 g 0.14 oz

    summer nude

    Close
  • Product Packaging - Terciopelo Negro

    YANBAL

    HYDRA-LIP LABIAL COLOR INTENSO

    INTENSE COLOR LIPSTICK

    SUNSCREEN SPF 15

    Net wt. 4 g 0.14 oz

    terciopelo negro

    Close
  • Product Packaging - Tierra de Rosas

    YANBAL

    HYDRA-LIP LABIAL COLOR INTENSO

    INTENSE COLOR LIPSTICK

    SUNSCREEN SPF 15

    Net wt. 4 g 0.14 oz

    tierra de rosas

    Close
  • Product Packaging - Velvet Rose

    YANBAL

    HYDRA-LIP LABIAL COLOR INTENSO

    INTENSE COLOR LIPSTICK

    SUNSCREEN SPF 15

    Net wt. 4 g 0.14 oz

    velvet rose

    Close
  • Product Packaging - West Malva

    YANBAL

    HYDRA-LIP LABIAL COLOR INTENSO

    INTENSE COLOR LIPSTICK

    SUNSCREEN SPF 15

    Net wt. 4 g 0.14 oz

    west malva

    Close
  • Product Packaging - Berry Wine

    YANBAL

    HYDRA-LIP LABIAL COLOR INTENSO

    INTENSE COLOR LIPSTICK

    SUNSCREEN SPF 15

    Net wt. 4 g 0.14 oz

    berry wine

    Close
  • Product Packaging - Bronz

    YANBAL

    HYDRA-LIP LABIAL COLOR INTENSO

    INTENSE COLOR LIPSTICK

    SUNSCREEN SPF 15

    Net wt. 4 g 0.14 oz

    bronz

    Close
  • Product Packaging - Classic Red

    YANBAL

    HYDRA-LIP LABIAL COLOR INTENSO

    INTENSE COLOR LIPSTICK

    SUNSCREEN SPF 15

    Net wt. 4 g 0.14 oz

    classic red

    Close
  • Product Packaging - Hot Summer

    YANBAL

    HYDRA-LIP LABIAL COLOR INTENSO

    INTENSE COLOR LIPSTICK

    SUNSCREEN SPF 15

    Net wt. 4 g 0.14 oz

    hot summer

    Close
  • Product Packaging - Native Nude

    YANBAL

    HYDRA-LIP LABIAL COLOR INTENSO

    INTENSE COLOR LIPSTICK

    SUNSCREEN SPF 15

    Net wt. 4 g 0.14 oz

    native nude

    Close
  • Product Packaging - Solarium

    YANBAL

    HYDRA-LIP LABIAL COLOR INTENSO

    INTENSE COLOR LIPSTICK

    SUNSCREEN SPF 15

    Net wt. 4 g 0.14 oz

    solarium

    Close
  • Product Packaging - Tentacion

    YANBAL

    HYDRA-LIP LABIAL COLOR INTENSO

    INTENSE COLOR LIPSTICK

    SUNSCREEN SPF 15

    Net wt. 4 g 0.14 oz

    tentacion

    Close
  • Product Packaging - Arena Dorada

    YANBAL

    HYDRA-LIP LABIAL COLOR INTENSO

    INTENSE COLOR LIPSTICK

    SUNSCREEN SPF 15

    Net wt. 4 g 0.14 oz

    arena dorada

    Close
  • Product Packaging - Fuego Colorado

    YANBAL

    HYDRA-LIP LABIAL COLOR INTENSO

    INTENSE COLOR LIPSTICK

    SUNSCREEN SPF 15

    Net wt. 4 g 0.14 oz

    fuego colorado

    Close
  • Product Packaging - Ultra Red

    YANBAL

    HYDRA-LIP LABIAL COLOR INTENSO

    INTENSE COLOR LIPSTICK

    SUNSCREEN SPF 15

    Net wt. 4 g 0.14 oz

    ultra red

    Close
  • INGREDIENTS AND APPEARANCE
    YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 ROSA TOSCANA 
    octinoxate lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0024
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BENZYL CINNAMATE (UNII: V67O3RO97U)  
    GERANIOL (UNII: L837108USY)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    COPPER (UNII: 789U1901C5)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    MICA (UNII: V8A1AW0880)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23319-0024-1 1 in 1 CARTON 11/15/2018
    1 4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/15/2018
    YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 AMBRE 
    octinoxate lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0022
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BENZYL CINNAMATE (UNII: V67O3RO97U)  
    GERANIOL (UNII: L837108USY)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    COPPER (UNII: 789U1901C5)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    MICA (UNII: V8A1AW0880)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23319-0022-1 1 in 1 CARTON 11/15/2018
    1 4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/15/2018
    YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 DUSTY RED 
    octinoxate lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0039
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BENZYL CINNAMATE (UNII: V67O3RO97U)  
    GERANIOL (UNII: L837108USY)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    COPPER (UNII: 789U1901C5)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    MICA (UNII: V8A1AW0880)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23319-0039-1 1 in 1 CARTON 11/15/2018
    1 4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/15/2018
    YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 BRONZ 
    octinoxate lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0043
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BENZYL CINNAMATE (UNII: V67O3RO97U)  
    GERANIOL (UNII: L837108USY)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    COPPER (UNII: 789U1901C5)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    MICA (UNII: V8A1AW0880)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23319-0043-1 1 in 1 CARTON 11/15/2018
    1 4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/15/2018
    YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 TERCIOPELO NEGRO 
    octinoxate lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0021
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BENZYL CINNAMATE (UNII: V67O3RO97U)  
    GERANIOL (UNII: L837108USY)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    COPPER (UNII: 789U1901C5)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    MICA (UNII: V8A1AW0880)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23319-0021-1 1 in 1 CARTON 11/15/2018
    1 4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/15/2018
    YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 SUGAR POP 
    octinoxate lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0034
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BENZYL CINNAMATE (UNII: V67O3RO97U)  
    GERANIOL (UNII: L837108USY)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    COPPER (UNII: 789U1901C5)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    MICA (UNII: V8A1AW0880)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23319-0034-1 1 in 1 CARTON 11/15/2018
    1 4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/15/2018
    YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 SOLARIUM 
    octinoxate lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0046
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    COPPER (UNII: 789U1901C5)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    MICA (UNII: V8A1AW0880)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BENZYL CINNAMATE (UNII: V67O3RO97U)  
    GERANIOL (UNII: L837108USY)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23319-0046-1 1 in 1 CARTON 11/15/2018
    1 4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/15/2018
    YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 SUMMER NUDE 
    octinoxate lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0044
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BENZYL CINNAMATE (UNII: V67O3RO97U)  
    GERANIOL (UNII: L837108USY)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    COPPER (UNII: 789U1901C5)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    MICA (UNII: V8A1AW0880)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23319-0044-1 1 in 1 CARTON 11/15/2018
    1 4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/15/2018
    YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 HOT SUMMER 
    octinoxate lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0045
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    MICA (UNII: V8A1AW0880)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BENZYL CINNAMATE (UNII: V67O3RO97U)  
    GERANIOL (UNII: L837108USY)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    COPPER (UNII: 789U1901C5)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23319-0045-1 1 in 1 CARTON 11/15/2018
    1 4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/15/2018
    YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 ARENA DORADA 
    octinoxate lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0047
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BENZYL CINNAMATE (UNII: V67O3RO97U)  
    GERANIOL (UNII: L837108USY)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    COPPER (UNII: 789U1901C5)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    MICA (UNII: V8A1AW0880)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23319-0047-1 1 in 1 CARTON 11/15/2018
    1 4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/15/2018
    YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 ULTRA RED 
    octinoxate lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0027
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BENZYL CINNAMATE (UNII: V67O3RO97U)  
    GERANIOL (UNII: L837108USY)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    COPPER (UNII: 789U1901C5)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    MICA (UNII: V8A1AW0880)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23319-0027-1 1 in 1 CARTON 11/15/2018
    1 4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/15/2018
    YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 CREME NUDE 
    octinoxate lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0026
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BENZYL CINNAMATE (UNII: V67O3RO97U)  
    GERANIOL (UNII: L837108USY)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    COPPER (UNII: 789U1901C5)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    MICA (UNII: V8A1AW0880)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23319-0026-1 1 in 1 CARTON 11/15/2018
    1 4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/15/2018
    YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 TIERRA DE ROSAS 
    octinoxate lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0029
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BENZYL CINNAMATE (UNII: V67O3RO97U)  
    GERANIOL (UNII: L837108USY)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    COPPER (UNII: 789U1901C5)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    MICA (UNII: V8A1AW0880)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23319-0029-1 1 in 1 CARTON 11/15/2018
    1 4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/15/2018
    YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 BERRY WINE 
    octinoxate lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0030
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BENZYL CINNAMATE (UNII: V67O3RO97U)  
    GERANIOL (UNII: L837108USY)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    COPPER (UNII: 789U1901C5)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    MICA (UNII: V8A1AW0880)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23319-0030-1 1 in 1 CARTON 11/15/2018
    1 4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/15/2018
    YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 CLASSIC RED 
    octinoxate lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0032
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BENZYL CINNAMATE (UNII: V67O3RO97U)  
    GERANIOL (UNII: L837108USY)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    COPPER (UNII: 789U1901C5)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    MICA (UNII: V8A1AW0880)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23319-0032-1 1 in 1 CARTON 11/15/2018
    1 4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/15/2018
    YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 VELVET ROSE 
    octinoxate lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0033
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BENZYL CINNAMATE (UNII: V67O3RO97U)  
    GERANIOL (UNII: L837108USY)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    COPPER (UNII: 789U1901C5)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    MICA (UNII: V8A1AW0880)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23319-0033-1 1 in 1 CARTON 11/15/2018
    1 4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/15/2018
    YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 FUEGO COLORADO 
    octinoxate lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0038
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BENZYL CINNAMATE (UNII: V67O3RO97U)  
    GERANIOL (UNII: L837108USY)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    COPPER (UNII: 789U1901C5)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    MICA (UNII: V8A1AW0880)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23319-0038-1 1 in 1 CARTON 11/15/2018
    1 4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/15/2018
    YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 TENTACION 
    octinoxate lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0023
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BENZYL CINNAMATE (UNII: V67O3RO97U)  
    GERANIOL (UNII: L837108USY)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    COPPER (UNII: 789U1901C5)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    MICA (UNII: V8A1AW0880)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23319-0023-1 1 in 1 CARTON 11/15/2018
    1 4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/15/2018
    YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 LADY MALBEC 
    octinoxate lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0035
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BENZYL CINNAMATE (UNII: V67O3RO97U)  
    GERANIOL (UNII: L837108USY)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    COPPER (UNII: 789U1901C5)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    MICA (UNII: V8A1AW0880)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23319-0035-1 1 in 1 CARTON 11/15/2018
    1 4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/15/2018
    YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 BURDEO NIGHT 
    octinoxate lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0036
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BENZYL CINNAMATE (UNII: V67O3RO97U)  
    GERANIOL (UNII: L837108USY)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    COPPER (UNII: 789U1901C5)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    MICA (UNII: V8A1AW0880)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23319-0036-1 1 in 1 CARTON 11/15/2018
    1 4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/15/2018
    YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 HONEY NUDE 
    octinoxate lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0037
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BENZYL CINNAMATE (UNII: V67O3RO97U)  
    GERANIOL (UNII: L837108USY)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    COPPER (UNII: 789U1901C5)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    MICA (UNII: V8A1AW0880)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23319-0037-1 1 in 1 CARTON 11/15/2018
    1 4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/15/2018
    YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 NATIVE NUDE 
    octinoxate lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0040
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BENZYL CINNAMATE (UNII: V67O3RO97U)  
    GERANIOL (UNII: L837108USY)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    COPPER (UNII: 789U1901C5)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    MICA (UNII: V8A1AW0880)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23319-0040-1 1 in 1 CARTON 11/15/2018
    1 4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/15/2018
    YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 GUINDA ETNICO 
    octinoxate lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0025
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BENZYL CINNAMATE (UNII: V67O3RO97U)  
    GERANIOL (UNII: L837108USY)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    COPPER (UNII: 789U1901C5)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    MICA (UNII: V8A1AW0880)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23319-0025-1 1 in 1 CARTON 11/15/2018
    1 4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/15/2018
    YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 CHOCOLAT 
    octinoxate lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0028
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BENZYL CINNAMATE (UNII: V67O3RO97U)  
    GERANIOL (UNII: L837108USY)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    COPPER (UNII: 789U1901C5)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    MICA (UNII: V8A1AW0880)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23319-0028-1 1 in 1 CARTON 11/15/2018
    1 4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/15/2018
    YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 WEST MALVA 
    octinoxate lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0042
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BENZYL CINNAMATE (UNII: V67O3RO97U)  
    GERANIOL (UNII: L837108USY)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    COPPER (UNII: 789U1901C5)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    MICA (UNII: V8A1AW0880)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23319-0042-1 1 in 1 CARTON 11/15/2018
    1 4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/15/2018
    YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 ORQUIDEA PINK 
    octinoxate lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0031
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BENZYL CINNAMATE (UNII: V67O3RO97U)  
    GERANIOL (UNII: L837108USY)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    COPPER (UNII: 789U1901C5)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    MICA (UNII: V8A1AW0880)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23319-0031-1 1 in 1 CARTON 11/15/2018
    1 4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/15/2018
    Labeler - Yanbal USA, Inc. (001801369)
    Establishment
    Name Address ID/FEI Business Operations
    Yanbal de Colombia S.A.S. 880215657 manufacture(23319-0021, 23319-0022, 23319-0023, 23319-0024, 23319-0025, 23319-0026, 23319-0027, 23319-0028, 23319-0029, 23319-0030, 23319-0031, 23319-0032, 23319-0033, 23319-0034, 23319-0035, 23319-0036, 23319-0037, 23319-0038, 23319-0039, 23319-0040, 23319-0042, 23319-0043, 23319-0044, 23319-0045, 23319-0046, 23319-0047)
    Close

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