Label: DUANE READE SUNSCREEN SPF 15- octinoxate and oxybenzone lotion

  • 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 11/12

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Octinoxate 7.5%

    Oxybenzone 4.5%

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  • Purpose

    Sunscreen

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  • Uses

    • helps prevent sunburn
    • higher SPF gives more sunburn protection
    • retains SPF after 80 minutes of activity in the water
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  • Warnings

    For External use only

    When using this product

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

    Stop use and ask a doctor if

    • rash or irritation develops and lasts.

    Keep out of the reach of children.

    If swallowed get medical help or contact a Poison Control Center right away.

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  • Directions

    • shake well
    • apply generously before sun exposure and as needed
    • Children under 6 months of age:ask a doctor
    • reapplying frequently after towel drying, swimming or perspiring.
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  • Inactive Ingredients

    Water, Stearic Acid, Sorbitol, Sorbitan Oleate, Glyceryl Stearate SE, Hydrogenated Vegetable oil Isopropyl Myristate, Triethanolamine,VP/Eicosene Copolymer, Benzyl Alcohol, Imadazolidinyl Urea, Methylparaben, Dimethicone,Carbomer, Fragrance,Simmondsia Chinensis(Jojoba) Seed Oil, Propylparaben, Tocopherol, Aloe Barbadensis Leaf Juice, Disodium EDTA.

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  • Principal Display Panel

    UNIQUELY NY DRTM SINCE 1960

    SUNSCREEN

    15

    SPF

    moisturizing lotion

    UVA/UVB Protection

    Very water resistant

    8 FL OZ (237 mL)label.jpg

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  • INGREDIENTS AND APPEARANCE
    DUANE READE SUNSCREEN  SPF 15
    octinoxate lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:67732-400
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 g  in 100 g
    OXYBENZONE (OXYBENZONE ) OXYBENZONE 4.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    STEARIC ACID  
    SORBITOL  
    SORBITAN MONOOLEATE  
    GLYCERYL STEARATE SE  
    ISOPROPYL MYRISTATE  
    TROLAMINE  
    BENZYL ALCOHOL  
    IMIDUREA  
    METHYLPARABEN  
    DIMETHICONE  
    JOJOBA OIL  
    PROPYLPARABEN  
    TOCOPHEROL  
    ALOE VERA LEAF  
    EDETATE DISODIUM  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67732-400-16 226 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/13/2012
    Labeler - DUANE READE INC. (011988995)
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