Label: SUN SOLAR DEFENSE HYDRATING- zinc oxide, ethylhexyl methoxycinnamate, benzophenone, ethylhexyl salicylate cream

  • Category: HUMAN OTC DRUG LABEL

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 June 30, 2010

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  • ACTIVE INGREDIENT

    Active Ingredients:

    Zinc Oxide 5%

    Ethylhexyl Methoxycinnamate (Octinoxate) 7.5%

    Benzophenone-3 3%

    Ethylhexyl Salicylate (Octisalate) 5%

  • INDICATIONS & USAGE

    Uses:

    A hydrating UVA/UVB broad spectrum daily moisturizer. Provides ultimate protection against the aging effects of the sun and other environmental exposures. 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 to cleaned skin every morning for ultimate protection.

    Indications: Dry, dehydrated, rosacea, sensitive.

  • WARNINGS AND PRECAUTIONS

    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:

    Deionized water (Aqua), C12-15 Alkyl Benzoate, Glyceryl Stearate (and) PEG-100 Stearate, Glycerin, Sodium Hyaluronate, Imperata Cylindrica Root Extract, Octyl Dodecyl Neopentanoate, Sorbitol, Caprylic/Capric Truglyceride, Camellia sinensis (Green Tea) Leaf Extract, Biosaccharide Gum-1, Algae Extract and Mugwort Extract, Caprylyl Glycol and Phnoxyethanol and Hexylene Glycol, Sodium PCA, Lecithin, Sorbitan Stearate, Symphytum Officinale Extract and Plantago Ovata Seed Extract, Yeast Extract, Aloe Barbadensis Leaf Extract, Spiraea Ulmaria Flower Extract (and) Centella Asiatica Extract, Magnesium Aluminum Silicate, Tocopheryl Acetate, Ascorbyl Palmitate, Disodium EDTA, Dipotassium Glycyrrizate, Amino Acids.

  • PRINCIPAL DISPLAY PANEL

    Image of the Product:

    Image of the Product

    Distributor:

    Image International

    Palm Beach, FL 33411 USA

    www.imageskincare.com

  • INGREDIENTS AND APPEARANCE
    SUN SOLAR DEFENSE HYDRATING  
    zinc oxide, ethylhexyl methoxycinnamate, benzophenone, ethylhexyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4037
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE50 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
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4037-1118 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)