ZO SKIN HEALTH AGGRESSIVE ANTI-AGING PROGRAM (TITANIUM DIOXIDE) KIT [ZO SKIN HEALTH, INC.]

ZO SKIN HEALTH AGGRESSIVE ANTI-AGING PROGRAM (TITANIUM DIOXIDE) KIT [ZO SKIN HEALTH, INC.]
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NDC 42851-168-15
Set ID 09c44e81-6aa8-41e9-8624-041aab40093d
Category HUMAN OTC DRUG LABEL
Packager ZO Skin Health, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Titanium Dioxide 8.2%

  • 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 or irritation develops and lasts.

    Keep out of reach of children.

    • If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • children under 6 months of age: Ask a doctor
    • 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.
  • Other information

    • Protect this product from excessive heat and direct sun.
    • You may report a serious adverse reaction to: 5 Technology Dr. Irvine, CA 92618
  • Inactive ingredients

    Aluminum Hydroxide, Aqua/Water/Eau, Ascorbic Acid, Behenyl Behenate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Chlorphenesin, Cyclopentasiloxane, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium Uridine Phosphate, Ethyl Ferulate, Ethylhexylglycerin, Glycerin, Glycine Soja Extract, Helianthus Annuus Seed Oil, Hexyl Laurate, Iron Oxides, Melanin, Myristoyl Pentapeptide-8, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Pentylene Glycol, Phenoxyethanol, Phenyl Trimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Polyglyceryl-4 Isostearate, Polyglyceryl-5 Trioleate, Polymethyl Methacrylate, Retinyl Palmitate, Rosmarinus Officinalis Leaf Extract, Squalane, Stearic Acid, Tocopherol, Tocopheryl Acetate, Tribehenin, Triethoxycaprylylsilane.

  • SPL UNCLASSIFIED SECTION

    Dist. by ZO Skin Health, Inc. Irvine, CA 92618

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    ZO ® SKIN HEALTH
    BY ZEIN OBAGI MD

    AGGRESSIVE ANTI-AGING PROGRAM
    NDC 42851-168-15

    HYDRATING CLEANSER 60 mL / 2 Fl. Oz. EXFOLIATING POLISH Net Wt. 16.2 g / 0.57 Oz.
    COMPLEXION RENEWAL PADS 30 Pads DAILY POWER DEFENSE 30 mL / 1 Fl. Oz.
    ADVANCED RADICAL NIGHT REPAIR 30 mL / 1 Fl. Oz. RENEWAL CRÈME 50 mL / 1.7 Fl. Oz.
    SUNSCREEN + PRIMER SPF 30 15 mL / 0.5 Fl. Oz.

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    ZO SKIN HEALTH AGGRESSIVE ANTI-AGING PROGRAM  
    titanium dioxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-168
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-168-151 in 1 CARTON11/01/2017
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 60 mL
    Part 21 JAR 16.2 g
    Part 31 BOTTLE, GLASS 30 
    Part 41 BOTTLE, PUMP 30 mL
    Part 51 TUBE, WITH APPLICATOR 30 mL
    Part 61 JAR 50 mL
    Part 71 BOTTLE, PUMP 15 mL
    Part 1 of 7
    ZO SKIN HEALTH HYDRATING CLEANSER 
    cleansing (cold creams, cleansing lotions, liquids, and pads) lotion
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRSODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    INGRSODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    INGRPEG-100 STEARATE (UNII: YD01N1999R)  
    INGRSTEARIC ACID (UNII: 4ELV7Z65AP)  
    INGRDISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    INGRGLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    INGRPALMITIC ACID (UNII: 2V16EO95H1)  
    INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
    INGRPANTHENOL (UNII: WV9CM0O67Z)  
    INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    INGRUREA (UNII: 8W8T17847W)  
    INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    INGRTREHALOSE (UNII: B8WCK70T7I)  
    INGRPOLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    INGRTRIACETIN (UNII: XHX3C3X673)  
    INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
    INGRLINALOOL, (+/-)- (UNII: D81QY6I88E)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRALLANTOIN (UNII: 344S277G0Z)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRD&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    INGRFD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    160 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic11/01/2017
    Part 2 of 7
    ZO SKIN HEALTH EXFOLIATING POLISH 
    lotions, oils, powders, and creams cream
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRPOLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    INGRSODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    INGRMAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    INGRDIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGROLETH-20 (UNII: YTH167I2AG)  
    INGRTRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    INGRPEG-100 STEARATE (UNII: YD01N1999R)  
    INGRMINERAL OIL (UNII: T5L8T28FGP)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRTEA TREE OIL (UNII: VIF565UC2G)  
    INGRSOY STEROL (UNII: PL360EPO9J)  
    INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
    INGRLINALOOL, (+/-)- (UNII: D81QY6I88E)  
    INGRASCORBYL PALMITATE (UNII: QN83US2B0N)  
    INGRVITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    INGRSTEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)  
    INGRTETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    INGRLINOLEIC ACID (UNII: 9KJL21T0QJ)  
    INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRD&C GREEN NO. 6 (UNII: 4QP5U84YF7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    116.2 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic11/01/2017
    Part 3 of 7
    ZO SKIN HEALTH COMPLEXION RENEWAL PADS 
    cleansing (cold creams, cleansing lotions, liquids, and pads) patch
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRPROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    INGRSALICYLIC ACID (UNII: O414PZ4LPZ)  
    INGRUREA (UNII: 8W8T17847W)  
    INGRGLYCOLIC ACID (UNII: 0WT12SX38S)  
    INGRPTEROCARPUS SOYAUXII WOOD (UNII: 0V6QB4C61P)  
    INGRPHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)  
    INGRBARLEY (UNII: 5PWM7YLI7R)  
    INGRGREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    INGRPLANTAGO LANCEOLATA LEAF (UNII: 2YWL9J7EE8)  
    INGRCRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
    INGRLINALOOL, (+/-)- (UNII: D81QY6I88E)  
    INGR.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    INGRISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic11/01/2017
    Part 4 of 7
    ZO SKIN HEALTH OSSENTIAL DAILY POWER DEFENSE 
    cleansing (cold creams, cleansing lotions, liquids, and pads) lotion
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRCETEARYL ISONONANOATE (UNII: P5O01U99NI)  
    INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    INGRCYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRPENTYLENE GLYCOL (UNII: 50C1307PZG)  
    INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    INGRSTEARETH-20 (UNII: L0Q8IK9E08)  
    INGRC14-22 ALCOHOLS (UNII: B1K89384RJ)  
    INGRCETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    INGRSAFFLOWER OIL (UNII: 65UEH262IS)  
    INGRCARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    INGRC12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    INGRLACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    INGRPOWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    INGRRETINOL (UNII: G2SH0XKK91)  
    INGR1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    INGRHYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    INGRARABIDOPSIS THALIANA (UNII: AI3L60HQ81)  
    INGRORANGE OIL (UNII: AKN3KSD11B)  
    INGRMANDARIN OIL (UNII: NJO720F72R)  
    INGRLEMON OIL (UNII: I9GRO824LL)  
    INGRPEPPERMINT OIL (UNII: AV092KU4JH)  
    INGRMIMOSA TENUIFLORA BARK (UNII: 515MQE449I)  
    INGRTANGERINE (UNII: KH3E3096OO)  
    INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGRFARNESOL (UNII: EB41QIU6JL)  
    INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
    INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRPALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
    INGRPALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    INGRVITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGRHEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRULTRAMARINE BLUE (UNII: I39WR998BI)  
    INGREXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic11/01/2017
    Part 5 of 7
    ZO SKIN HEALTH OSSENTIAL ADVANCED RADICAL NIGHT REPAIR 
    lotions, oils, powders, and creams lotion
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    INGRDIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGRRETINOL (UNII: G2SH0XKK91)  
    INGRDIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRBUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRSODIUM SULFITE (UNII: VTK01UQK3G)  
    INGRASCORBYL PALMITATE (UNII: QN83US2B0N)  
    INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    INGRTOCOPHEROL (UNII: R0ZB2556P8)  
    INGRASCORBIC ACID (UNII: PQ6CK8PD0R)  
    INGRPLUKENETIA VOLUBILIS SEED OIL (UNII: 8ED72Z8J1Z)  
    INGRSUNFLOWER OIL (UNII: 3W1JG795YI)  
    INGRZANTHOXYLUM BUNGEANUM FRUIT (UNII: 3CIP16A418)  
    INGRROSEMARY (UNII: IJ67X351P9)  
    INGRCORN OIL (UNII: 8470G57WFM)  
    INGR.BETA.-CAROTENE (UNII: 01YAE03M7J)  
    INGRCITRAL (UNII: T7EU0O9VPP)  
    INGRGERANIOL (UNII: L837108USY)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRCHLORPHENESIN (UNII: I670DAL4SZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic11/01/2017
    Part 6 of 7
    ZO SKIN HEALTH OMMERSE RENEWAL CREME 
    lotions, oils, powders, and creams cream
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    INGRISOCETYL STEARATE (UNII: 3RJ7186O9W)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    INGRSILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    INGRECTOINE (UNII: 7GXZ3858RY)  
    INGRSTEARETH-21 (UNII: 53J3F32P58)  
    INGRLAURETH-23 (UNII: N72LMW566G)  
    INGRCARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    INGRPOLYSORBATE 60 (UNII: CAL22UVI4M)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRSTEARETH-2 (UNII: V56DFE46J5)  
    INGREDETATE SODIUM (UNII: MP1J8420LU)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRHEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGRRETINOL (UNII: G2SH0XKK91)  
    INGRCOCONUT OIL (UNII: Q9L0O73W7L)  
    INGRHYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
    INGRTOCOPHEROL (UNII: R0ZB2556P8)  
    INGRHYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    INGREPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)  
    INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    INGROAT (UNII: Z6J799EAJK)  
    INGRGARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    INGRMAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    INGRUBIDECARENONE (UNII: EJ27X76M46)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    150 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic11/01/2017
    Part 7 of 7
    ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVAUVB PROTECTION 
    titanium dioxide lotion
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE82 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    WATER (UNII: 059QF0KO0R)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    BEHENYL BEHENATE (UNII: K8NU647RJ0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)  
    URIDINE MONOPHOSPHATE DISODIUM (UNII: KD8E20071T)  
    ETHYL FERULATE (UNII: 5B8915UELW)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ROSEMARY (UNII: IJ67X351P9)  
    SQUALANE (UNII: GW89575KF9)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    115 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/01/2017
    Labeler - ZO Skin Health, Inc. (826468527)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lifetech Resources, LLC.081239587manufacture(42851-168)
    Establishment
    NameAddressID/FEIBusiness Operations
    Thibiant International, Inc.083913913manufacture(42851-168)
    Establishment
    NameAddressID/FEIBusiness Operations
    DIAMOND WIPES INTERNATIONAL INC161104729manufacture(42851-168)
    Establishment
    NameAddressID/FEIBusiness Operations
    PakLab790530976manufacture(42851-168)

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