ZO SKIN HEALTH OCLIPSE SMART TONE BROAD-SPECTRUM SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [ZO SKIN HEALTH, INC.]

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  • ZO SKIN HEALTH OCLIPSE SMART TONE BROAD-SPECTRUM SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [ZO SKIN HEALTH, INC.]

ZO SKIN HEALTH OCLIPSE SMART TONE BROAD-SPECTRUM SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [ZO SKIN HEALTH, INC.]
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NDC 42851-055-17, 42851-055-45
Set ID cda67d41-d063-4936-a6b9-23376304eb42
Category HUMAN OTC DRUG LABEL
Packager ZO Skin Health, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients Purpose
    Avobenzone 3%Sunscreen
    Homosalate 10%Sunscreen
    Octisalate 5%Sunscreen
    Octocrylene 10%Sunscreen
  • Uses

    • Helps prevent sunburn
    • Higher SPF gives more sunburn protection
    • Provides high protection against sunburn
    • If used as directed with other sun protection measures (see Directions) , decreases the risk of skin cancer and early skin aging caused by 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 swallowed, get medical help or contact a Poison Control Center right away
  • Directions

    • Apply liberally 15 minutes before sun exposure and as needed.
    • 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

    • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
    • Protect the product in this container from excessive heat and direct sun.
    • You may report a serious adverse reaction to: 9685 Research Dr., Irvine, CA 92618
  • Inactive ingredients

    Water, Dimethicone, Butyloctyl Salicylate, Styrene/Acrylates Copolymer, Dimethicone/ Divinyldimethicone/Silsesquioxane Crosspolymer, PEG-100 Stearate, Mica, Glyceryl Stearate, Butylene Glycol, Polyamide-5, Steareth-21, Dimethicone/Vinyl Dimethicone Crosspolymer, Argania Spinosa Kernel Oil, Cetearyl Alcohol, Fatty Acid Ethoxylate, Helianthus Annuus (Sunflower) Seed Oil, Caprylyl Glycol, Ethylene Brassylate, Steareth-2, Coco-Glucoside, Acrylates Crosspolymer-4, Panthenyl Triacetate, Polymethyl Methacrylate, Acrylates/Ammonium Methacrylate Copolymer, Fragrance, Ethyl Linoleate, Disodium EDTA, Glycerin, Hexylene Glycol, Aluminum Hydroxide, Oleyl Alcohol, Isostearic Acid, Melanin, Pentylene Glycol, Boron Nitride, Ethyl Ferulate, C12-15 Alkyl Benzoate, Sodium Hydroxide, Tocopheryl Acetate, Tocopherol, Stearic Acid, Tetrahexyldecyl Ascorbate, Petasites Japonicus Root Extract, 1,2-Hexanediol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Ascorbic Acid, Retinyl Palmitate, Cyclotetrasiloxane, Silica Dimethyl Silylate, Beta-Glucan, Potassium Sorbate, C14-18 Glycol Esters, PEG-6 Stearate, PEG-32, Ethylhexylglycerin, Sorbic Acid, Phenoxyethanol, Titanium Dioxide, Iron Oxides.

  • SPL UNCLASSIFIED SECTION

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

    Made in USA with US & imported materials

    zoskinhealth.com | 941100

  • PRINCIPAL DISPLAY PANEL - 45 mL Tube Carton

    ZO ® SKIN HEALTH

    BY ZEIN OBAGI MD

    NDC 42851-055-45


    SMART TONE

    BROAD-SPECTRUM

    SUNSCREEN SPF 50

    ZOX 12®

    45 mL / 1.5 Fl. Oz.

    US Smart Tone - Full- Unit Carton

  • INGREDIENTS AND APPEARANCE
    ZO SKIN HEALTH SMART TONE BROAD-SPECTRUM SUNSCREEN SPF 50 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-055
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    SORBIC ACID (UNII: X045WJ989B)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    PETASITES JAPONICUS ROOT (UNII: 6F650HF10T)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    STEARETH-2 (UNII: V56DFE46J5)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    WATER (UNII: 059QF0KO0R)  
    MICA (UNII: V8A1AW0880)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    STEARETH-21 (UNII: 53J3F32P58)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    ETHYL LINOLEATE (UNII: MJ2YTT4J8M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    PEG-6 STEARATE (UNII: 8LQC57C6B0)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ROSEMARY (UNII: IJ67X351P9)  
    PANTHENOL TRIACETATE, (+)- (UNII: 1206E8961B)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ETHYL FERULATE (UNII: 5B8915UELW)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-055-451 in 1 CARTON02/02/2021
    145 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:42851-055-201 in 1 CARTON02/02/2021
    220 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/02/2021
    Labeler - ZO Skin Health, Inc. (826468527)
    Establishment
    NameAddressID/FEIBusiness Operations
    LIFETECH RESOURCES LLC622559110manufacture(42851-055)
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