LANEIGE BB CUSHION HYDRA RADIANCE NO.11 PORCELAIN (ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDE) LOTION LANEIGE BB CUSHION HYDRA RADIANCE NO.21 BEIGE (ZINC OXIDE, OCTINOXATE, AND TITANIUM DIO

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  • LANEIGE BB CUSHION HYDRA RADIANCE NO.11 PORCELAIN (ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDE) LOTION LANEIGE BB CUSHION HYDRA RADIANCE NO.21 BEIGE (ZINC OXIDE, OCTINOXATE, AND TITANIUM DIO

LANEIGE BB CUSHION HYDRA RADIANCE NO.11 PORCELAIN (ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDE) LOTION LANEIGE BB CUSHION HYDRA RADIANCE NO.21 BEIGE (ZINC OXIDE, OCTINOXATE, AND TITANIUM DIO
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NDC 43419-751-31, 43419-752-31, 43419-752-36, 43419-753-31, 43419-753-36, 43419-754-31, 43419-755-31, 43419-756-31
Set ID cf6c1c52-801f-4eb9-b0f9-2b9a56da4f84
Category HUMAN OTC DRUG LABEL
Packager Amorepacific Corporation
Generic Name
Product Class
Product Number
Application Number PART352
View All Sections
  • Drug Facts

  • ACTIVE INGREDIENTS

    OCTINOXATE 7%, TITANIUM DIOXIDE 4.15%, ZINC OXIDE 9.8%

  • PURPOSE

    Sunscreen

  • USES

    • Helps prevent sunburn.
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • WARNINGS

    • For external use only.

    • Do not use on damaged or broken skin.

    • When using this product keep out of eyes. Rinse with water to remove.

    • Stop use and ask a doctor if rash occurs.

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

    • Apply liberally 15 minutes before sun exposure.
    • Reapply at least every 2 hours.
    • Use a water-resistant sunscreen if swimming or sweating.
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging.
    • To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m.- 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months of age: Ask a doctor.
  • OTHER INFORMATION

    • Protect the product in this container from excessive heat and direct sun.
  • INACTIVE INGREDIENTS

    WATER / AQUA / EAU, CYCLOPENTASILOXANE, TITANIUM DIOXIDE (CI 77891), PEG-10 DIMETHICONE, CYCLOHEXASILOXANE, PHENYL TRIMETHICONE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, NIACINAMIDE, ACRYLATES /ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, METHYL METHACRYLATE CROSSPOLYMER, BUTYLENE GLYCOL, SODIUM CHLORIDE, ALUMINUM HYDROXIDE, IRON OXIDES (CI 77492), HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, STEARIC ACID, TRIETHOXYCAPRYLYLSILANE, PHENOXYETHANOL, FRAGRANCE / PARFUM, DISTEARDIMONIUM HECTORITE, CAPRYLYL GLYCOL, YEAST EXTRACT / FAEX / EXTRAIT DE LEVURE, ACRYLATES/STEARYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, IRON OXIDES (CI 77491), DIMETHICONE, TRIMETHYLSILOXYSILICATE, POLYSORBATE 80, DISODIUM EDTA, IRON OXIDES (CI 77499), HYDROGENATED LECITHIN, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, MICA (CI 77019), SILICA, 1,2-HEXANEDIOL, POLYPROPYLSILSESQUIOXANE, CHENOPODIUM QUINOA SEED EXTRACT, MAGNESIUM SULFATE, CALCIUM CHLORIDE, CAMELLIA SINENSIS LEAF EXTRACT, MANGANESE SULFATE, ZINC SULFATE, ASCORBYL GLUCOSIDE

  • QUESTIONS?

    • For US customers: support@us.amorepacific.com
    • For Canada customers: support@ca.amorepacific.com
  • PRINCIPAL DISPLAY PANEL - 15 g x 2 Container Carton - No.11 Porcelain

    LANEIGE

    BB Cushion
    Hydra Radiance

    No.11 Porcelain

    Broad Spectrum SPF 50+ Sunscreen

    Net wt. 1.05 OZ. / 30 g (15 g x 2) e
    DIN 02462273

    PRINCIPAL DISPLAY PANEL - 15 g x 2 Container Carton - No.11 Porcelain
  • PRINCIPAL DISPLAY PANEL - x 2 (15 g x 2 Container Carton) Carton - No.21 Beige

    LANEIGE

    TRAVEL EXCLUSIVE

    BB Cushion Duo
    Hydra Radiance

    No.21 Beige

    Broad Spectrum SPF 50+ Sunscreen

    Net wt. 1.05 OZ. X 2 EA / 30 g (15 g x 2) X 2 EA e
    DIN 02462273

    PRINCIPAL DISPLAY PANEL - x 2 (15 g x 2 Container Carton) Carton - No.21 Beige
  • PRINCIPAL DISPLAY PANEL - x 2 (15 g x 2 Container Carton) Carton - No.23 Sand

    LANEIGE

    TRAVEL EXCLUSIVE

    BB Cushion
    Hydra Radiance Duo

    No.23 Sand

    Broad Spectrum SPF 50+ Sunscreen

    Net wt. 1.05 OZ. X 2 EA / 30 g (15 g x 2) X 2 EA e
    DIN 02462273

    PRINCIPAL DISPLAY PANEL - x 2 (15 g x 2 Container Carton) Carton - No.23 Sand
  • PRINCIPAL DISPLAY PANEL - 15 g x 2 Container Carton - No.33 Cinnamon

    LANEIGE

    BB Cushion
    Hydra Radiance

    No.33 Cinnamon

    Broad Spectrum SPF 50+ Sunscreen

    Net wt. 1.05 OZ. / 30 g (15 g x 2) e
    DIN 02462273

    PRINCIPAL DISPLAY PANEL - 15 g x 2 Container Carton - No.33 Cinnamon
  • PRINCIPAL DISPLAY PANEL - 15 g x 2 Container Carton - No.35 Coffee

    LANEIGE

    BB Cushion
    Hydra Radiance

    No.35 Coffee

    Broad Spectrum SPF 50+ Sunscreen

    Net wt. 1.05 OZ. / 30 g (15 g x 2) e
    DIN 02462273

    PRINCIPAL DISPLAY PANEL - 15 g x 2 Container Carton - No.35 Coffee
  • PRINCIPAL DISPLAY PANEL - 15 g x 2 Container Carton - No.37 Cacao

    LANEIGE

    BB Cushion
    Hydra Radiance

    No.37 Cacao

    Broad Spectrum SPF 50+ Sunscreen

    Net wt. 1.05 OZ. / 30 g (15 g x 2) e
    DIN 02462273

    PRINCIPAL DISPLAY PANEL - 15 g x 2 Container Carton - No.37 Cacao
  • INGREDIENTS AND APPEARANCE
    LANEIGE BB CUSHION HYDRA RADIANCE NO.11 PORCELAIN 
    zinc oxide, octinoxate, and titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-751
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.94 g  in 30 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.1 g  in 30 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.245 g  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MANGANESE SULFATE (UNII: W00LYS4T26)  
    ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43419-751-312 in 1 CARTON12/26/201611/08/2021
    115 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35212/26/201611/08/2021
    LANEIGE BB CUSHION HYDRA RADIANCE NO.21 BEIGE 
    zinc oxide, octinoxate, and titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-752
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.94 g  in 30 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.1 g  in 30 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.245 g  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MANGANESE SULFATE (UNII: W00LYS4T26)  
    ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43419-752-312 in 1 CARTON12/26/201601/10/2020
    115 g in 1 CONTAINER; Type 0: Not a Combination Product
    2NDC:43419-752-362 in 1 CARTON12/26/201611/08/2021
    2NDC:43419-752-312 in 1 CARTON
    215 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35212/26/201611/08/2021
    LANEIGE BB CUSHION HYDRA RADIANCE NO.23 SAND 
    zinc oxide, octinoxate, and titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-753
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.94 g  in 30 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.1 g  in 30 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.245 g  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MANGANESE SULFATE (UNII: W00LYS4T26)  
    ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43419-753-312 in 1 CARTON12/26/201601/10/2020
    115 g in 1 CONTAINER; Type 0: Not a Combination Product
    2NDC:43419-753-362 in 1 CARTON12/26/201611/08/2021
    2NDC:43419-753-312 in 1 CARTON
    215 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35212/26/201611/08/2021
    LANEIGE BB CUSHION HYDRA RADIANCE NO.33 CINNAMON 
    zinc oxide, octinoxate, and titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-754
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.94 g  in 30 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.1 g  in 30 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.245 g  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MANGANESE SULFATE (UNII: W00LYS4T26)  
    ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43419-754-312 in 1 CARTON12/26/201612/16/2021
    115 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35212/26/201612/16/2021
    LANEIGE BB CUSHION HYDRA RADIANCE NO.35 COFFEE 
    zinc oxide, octinoxate, and titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-755
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.94 g  in 30 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.1 g  in 30 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.245 g  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MANGANESE SULFATE (UNII: W00LYS4T26)  
    ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43419-755-312 in 1 CARTON12/26/201604/18/2021
    115 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35212/26/201604/18/2021
    LANEIGE BB CUSHION HYDRA RADIANCE NO.37 CACAO 
    zinc oxide, octinoxate, and titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-756
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.94 g  in 30 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.1 g  in 30 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.245 g  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MANGANESE SULFATE (UNII: W00LYS4T26)  
    ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43419-756-312 in 1 CARTON12/26/201604/09/2021
    115 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35212/26/201604/09/2021
    Labeler - Amorepacific Corporation (631035289)
    Establishment
    NameAddressID/FEIBusiness Operations
    Amorepacific Corporation694894112MANUFACTURE(43419-751, 43419-752, 43419-753, 43419-754, 43419-755, 43419-756)
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