Label: SUN SOLAR DEFENSE OIL-FREE GEL SPF 15- titanium dioxide, ethylhexyl methoxycinnamate, benzophenone-3 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 July 1, 2010

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  • ACTIVE INGREDIENT

    Active Ingredients:

    Titanium Dioxide 1.6%

    Ethylhexyl Methoxycinnamate (Octinoxate) 7.50%

    Benzophenone-3: 3.00%


  • PURPOSE

    Purpose:

    Sunscreen

  • INDICATIONS & USAGE

    Uses:

    • An oil-free UVA/UVB broad spectrum daily moisturizer. Provides ultimate protection against the aging effects of the sun and other environmental exposure. Enriched with essential vitamins and anti-oxidants that prevent free radical damage and preserving skin hydration for the entire day.
    • Water-resistant
    • Paraben-free
    Directions:

    Apply liberally 15-30 minute prior to sun exposure. Reapply after prolonged swimming or vigorous activity.

    Indications:

    Universal for all skin types.
  • WARNINGS

    Warnings:

    For external use only.

    When using this product

    • Keep out of eyes. If contact occurs rinse with water.
    • Discontinue use if irritation or redness occurs.
    Keep out of reach of children
  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Water (Aqua), Ethylhexyl Methoxycinnamate, Ascorbyl Palmitate, Cyclomethicone, Benzophenone-3, Glycerin, Glyceryl Stearate, Camellia Sinensis Leaf Extract (Green Tea), Tocopheryl Acetate, Phenoxyethanol, Lecithin, C13-14 Isoparaffin Citrus blend, Xanthan Gum, Disodium EDTA.

  • PRINCIPAL DISPLAY PANEL

    Distributor:

    Image International
    Palm Beach, FL 33411 USA

    Image of the product:

    Sun Solar Defense Oil-free Gel SPF 15

    Image of the product

  • INGREDIENTS AND APPEARANCE
    SUN SOLAR DEFENSE OIL-FREE GEL SPF 15 
    titanium dioxide, ethylhexyl methoxycinnamate, benzophenone-3 cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4039
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE16 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE30 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4039-1118 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/01/2010
    Labeler - Allure Labs, Inc. (926831603)
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