Label: CONDITION AND ENHANCE HEALTHY SKIN PROTECTION SPF 35- octinoxate and zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 15, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Octinoxate, 7.5%, Zinc Oxide, 9%

  • Purpose

    Sunscreens

  • Uses

    • Helps prevent sunburn.
    • Higher SPF gives more sunburn protection.
  • Warnings

    • For external use only.

    When using this product

    • Keep out of eyes. Rinse with water to remove.

    Stop use and ask a physician if

    • Rash or irritation develops and lasts.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • Apply generously and evenly 15 minutes before sun exposure.
    • Children under six months of age: Ask a physician.
    • Reapply as needed or after towel drying, swimming or perspiring.
  • Other Information

    • Store at controlled room temperature: 15°-30°C (59°-86°F).
    • High sun protection product.
    • 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.
  • Inactive Ingredients

    Butylparaben, cetearyl alcohol, citric acid, C13-14 isoparaffin, diethanolamine cetyl phosphate, disodium edetate, ethylparaben, isobutylparaben, isopropyl palmitate, laureth-7, methylparaben, octyl stearate, phenoxyethanol, polyacrylamide, polyether-1, polysorbate 60, propylparaben, purified water, sodium hydroxide, triethoxycaprylysilane.

  • SPL UNCLASSIFIED SECTION

    Dist. by OMP Inc. Long Beach, CA 90802

  • PRINCIPAL DISPLAY PANEL - 90 mL Bottle Label

    OBAGI®
    MEDICAL

    CONDITION & ENHANCE

    AM 6

    healthy skin
    protection
    SPF 35

    Broad-Spectrum
    UVA/UVB Sunscreen

    RECOMMENDED
    SKIN
    CANCER
    FOUNDATION

    3 FL. OZ. (90 mL)

    Principal Display Panel - 90 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    CONDITION AND ENHANCE HEALTHY SKIN PROTECTION  SPF 35
    octinoxate and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-119
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE90 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-119-1030 mL in 1 BOTTLE, PLASTIC
    2NDC:62032-119-9090 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/01/2002
    Labeler - OMP, Inc. (790553353)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss-American Products611921669MANUFACTURE(62032-119)
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