Label: VITAMIN E MOISTURE  SPF 15- octinoxate, octisalate and avobenzone lotion 

  • Label RSS
  • NDC Code(s): 57691-098-01
  • Packager: The Body Shop Wake Forrest
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 06/14

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  • Active Ingredients

    Octinoxate (6.0%)                 

    Octisalate (4.0%)                  

    Avobenzone (3.0%)              

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  • Purpose

    Sunscreen

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  • Warnings

    For external use only

    Do not use

    on broken or damaged 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 product is swallowed, get mecial help or contact a Poison Control Center right away

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  • Directions

    • Apply liberally 15 minutes before sun exposure
    • 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 of 15 or higher and other sun protection measures including:

    • limit time in sun especially from 10 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats and sunglasses
    • reapply this product at least every 2 hours.
    • use water resistant sunscreen if swimming or sweating.
    • children under 6 months of age: ask a doctor
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  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Water, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Glyceryl Stearate, Butylene Glycol, Phenyl Trimethicone, Potassium Cetyl Phosphate, Cetyl Dimethicone, Phenoxyethanol, Triethanolamine, Sesamum Indicum (Sesame) Seed Oil,  Tocopheryl Acetate, Fragrance, Carbomer, Behenyl Alcohol, Cetyl Alcohol, Methylparaben, Triticum Vulgare (Wheat) Germ Oil, Citronellol, Tetrasodium EDTA, Butylparaben, Alpha-Isomethyl Ionone, Isobutylparaben, Propylparaben, Linalool, Geraniol, Limonene, Citral, Tocopherol, Eugenol, Famesol, Benxyl Alcohol, Isoeugenol.

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  • INGREDIENTS AND APPEARANCE
    VITAMIN E MOISTURE   SPF 15
    octinoxate, octisalate, avobenzone lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57691-098
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (OCTINOXATE) OCTINOXATE 6 g  in 100 mL
    OCTISALATE (OCTISALATE) OCTISALATE 4 g  in 100 mL
    AVOBENZONE (AVOBENZONE) AVOBENZONE 3 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    CYCLOMETHICONE  
    GLYCERYL MONOSTEARATE  
    PHENYL TRIMETHICONE  
    1,3-BUTYLENE GLYCOL  
    PHENOXYETHANOL  
    METHYLPARABEN  
    ETHYLPARABEN  
    PROPYLPARABEN  
    BUTYLPARABEN  
    TROLAMINE  
    SESAME OIL  
    ALPHA-TOCOPHEROL ACETATE  
    CETYL ALCOHOL  
    DOCOSANOL  
    EDETATE SODIUM  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57691-098-01 50 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 02/01/2007
    Labeler - The Body Shop Wake Forrest (791071279)
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