Label: DUANE READE PREVAIL MOISTURIZING SUNSCREEN SPF 80- avobenzone, octocrylene, oxybenzone, homosalate and octisalate 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:

    Avobenzone 3.0 %

    Homosalate 10.0%

    Octisalate 5.0%

    Octocrylene 5.0 %

    Oxybenzone 5.0%

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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:

    Apply generously and evenly before sun exposure and as needed
    • Children under 6 months of age:ask a doctor
    • Reapply frequently and after towel drying, swimming or perspiring.
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  • Other Information:

    May stain some fabrics.
    • Sun Alert: Limiting sun exposure, wearing, protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
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  • INACTIVE INGREDIENTS:

    Water, Styrene Acrylates Copolymer, Butyloctyl Salicylate, C12-20 Alkyl Glucoside, Caprylyl Glycol, Glycerin, Steareth-20, Polyester-7, Isopropyl Myristate, Steareth-2, Paraffin, Triethanolamine, Neopentyl Glycol Diheptanoate, C14-22 Alcohols, Carbomer, Polysorbate 60, Sodium Lauroyl Sarcosinate, Xanthan Gum, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Phenoxyethanol, Methylparaben, Propylparaben, Fragrance.

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  • Principal Display Panel

    PRevail

    moisturizing sunscreen

    spf 80

    • antioxidant-enriched
    • uva/uvb protection
    • hypoallergic
    • oil-free

    6.5 FL. OZ. (192 mL)ZDR017A0b.jpgZDR017A0f.jpg

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  • INGREDIENTS AND APPEARANCE
    DUANE READE PREVAIL MOISTURIZING SUNSCREEN  SPF 80
    avobenzone lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:67732-413
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (AVOBENZONE) AVOBENZONE 3 g  in 100 g
    OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 5 g  in 100 g
    OXYBENZONE (OXYBENZONE) OXYBENZONE 5 g  in 100 g
    HOMOSALATE (HOMOSALATE) HOMOSALATE 10 g  in 100 g
    OCTISALATE (OCTISALATE) OCTISALATE 5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    BUTYLOCTYL SALICYLATE  
    C12-20 ALKYL GLUCOSIDE  
    CAPRYLYL GLYCOL  
    GLYCERIN  
    STEARETH-20  
    POLYESTER-7  
    ISOPROPYL MYRISTATE  
    STEARETH-2  
    PARAFFIN  
    TROLAMINE  
    NEOPENTYL GLYCOL DIHEPTANOATE  
    C14-22 ALCOHOLS  
    POLYSORBATE 60  
    SODIUM LAUROYL SARCOSINATE  
    ALOE VERA LEAF  
    XANTHAN GUM  
    VITAMIN A PALMITATE  
    PHENOXYETHANOL  
    METHYLPARABEN  
    PROPYLPARABEN  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67732-413-55 184 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 11/14/2012
    Labeler - DUANE READE INC. (011988995)
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