Label: SUN TINTED SOLAR DEFENSE ORGANIC SPF 30- 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 July 2, 2010

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  • PURPOSE

    Purpose:

    A physical organic UVA/UVB broad spectrum daily moisturizer. Provides an even skin tone and healthy glow. Ultimate protection against the aging effects of the sun and other environmental pollutants. Enriched with essential vitamins and anti-oxidants that prevent free facical damage. Preserves skin hydration for the entire day.

    Paraben Free

    Provides Healthy even glow

    Excellent for sensitive skin

    Chemical free

    Water resistant

  • INDICATIONS & USAGE

    Directions:

    Apply liberally 15-30 minutes prior to sun exposure or as needed for a even skin tone. Reapply regulary or after prolonged swimming or activity.


    Indications:

    Sensitive skin, Sun exposure, uneven skin tone

  • ACTIVE INGREDIENT

    Active Ingredients:

    Zinc Oxide 17%

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Water (Aqua), Butylene Glycol, Glycerin, Caprylic/Capric Triglyceride, Glyceryl Stearate, PEG 100 Stearate, Sorbitan Stearate, Imperata Cylindrica Root Extract, Phenoxyethanol, Tocophery Linoleate, Ascorbyl Palmitate (Vitamin C), Lecithin, Tocopherol (Vitamin E), Xanthan Gum, Citric Acid, C13-14 Isoparaffin, PEG 8, Ethylhexylglycerin, Sodium Lactate, Micrococcus Lysate, Arabidopsis Extract, Plankton Extract, Teprenone, Phoenix dactylifera (date) Extract, Laureth-7, Disodium EDTA, Dipotassium Glycyrrizate, Caprylyl Glycol, Ascorbic Acid (Viamin C), Carbomer, Iron Oxides (CL 72124, Cl 7212 and Cl72123)

  • PRINCIPAL DISPLAY PANEL

    Distributor:

    Image International

    Palm Beach, FL 33411 USA



    Image of the Product:

    SUN Tinted Solar Defense Organic SPF 30


    Image of the product


  • INGREDIENTS AND APPEARANCE
    SUN TINTED SOLAR DEFENSE ORGANIC SPF 30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4041
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE170 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4041-156.7 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)