Label: ZO SKIN HEALTH SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30- titanium dioxide and zinc oxide cream

  • NDC Code(s): 42851-060-15, 42851-060-30, 42851-060-75
  • Packager: ZO Skin Health, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 11, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Titanium Dioxide 1.0%Sunscreen
    Zinc Oxide 20.0%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 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: 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.
  • Inactive Ingredients

    Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, PEG-10 Dimethicone, Phenyl Trimethicone,Dimethicone/Vinyl DimethiconeCrosspolymer, Glycyrrhiza Uralensis (Licorice) Root Extract, Helianthus Annuus (Sunflower) Seed Oil, Centella Asiatica Extract, Ecklonia Kurome Extract, Glycine Soja (Soybean) Seed Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract,
    Hexyl Laurate, Polyglyceryl-4 Isostearate, Tribehenin, Bisabolol, Cetyl PEG/PPG-10/1 Dimethicone,Water, Glycerin, Squalane, Polymethyl Methacrylate, Dimethiconol, Caprylic/Capric Triglyceride, Stearic Acid, Alumina, Caprylyl Glycol, Behenyl Behenate, Melanin, Tocopheryl Acetate, Ethyl Ferulate, Triethoxycaprylylsilane, Ascorbic Acid, Retinyl Palmitate, Ethylhexylglycerin, Tocopherol,
    Myristoyl Pentapeptide-8, Pentylene Glycol, Phenoxyethanol, Chlorphenesin, Iron Oxides.

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

    ZO ® SKIN HEALTH



    BY ZEIN OBAGI MD

    NDC 42851-060-30

    SUNSCREEN + PRIMER



    BROAD-SPECTRUM



    SPF 30

    ZOX 12™

    30 mL / 1 Fl. Oz.

    US Sunscreen Primer SPF 30 Full Box.JPG

  • INGREDIENTS AND APPEARANCE
    ZO SKIN HEALTH SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 
    titanium dioxide and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-060
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE10 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    GLYCYRRHIZA URALENSIS (UNII: 42B5YD8F0K)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
    ECKLONIA KUROME (UNII: 802YF989GT)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    ROSEMARY (UNII: IJ67X351P9)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SQUALANE (UNII: GW89575KF9)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    BEHENYL BEHENATE (UNII: K8NU647RJ0)  
    ETHYL FERULATE (UNII: 5B8915UELW)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-060-151 in 1 CARTON10/31/2019
    115 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:42851-060-301 in 1 CARTON10/31/2019
    230 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    3NDC:42851-060-751 in 1 CARTON10/31/2019
    375 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 DrugM02010/31/2019
    Labeler - ZO Skin Health, Inc. (826468527)
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