Label: DUANE READE PREVAIL MOISTURIZING SUNSCREEN SPF 50- avobenzone, octocrylene 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:

    Avobenzone 2.0 %

    Octocrylene 8.0 %

    Oxybenzone 4.0%

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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 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, C12-15 Alkyl Benzoate, Polyglyceryl-3 Methylglucose Distearate, Acrylates/C12-22 Alkyl methacrylate Copolymer, Hydrated Silica, Dimethicone, Glyceryl Stearate, PEG_100 Stearate, Sodium Polyacrylate, Benzyl Alcohol, Disodium EDTA, PEG_8 Dimethicone, Aloe Barbadensis leaf Juice, Octyldodecanol, Retinyl Palmitate, Silica, Tocopheryl Acetate, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Phenoxyethanol, Methylparaben, Iodopropynyl Butylcarbamate, Propylparaben, Fragrance.

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  • Principal Display Panel

    PRevail

    moisturizing sunscreen

    spf 50

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

    6.5 FL. OZ. (192 mL)ZDR016A0f.jpgZDR016A0b.jpg

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  • INGREDIENTS AND APPEARANCE
    DUANE READE PREVAIL MOISTURIZING SUNSCREEN  SPF 50
    avobenzone lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:67732-412
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (AVOBENZONE) AVOBENZONE 2 g  in 100 g
    OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 8 g  in 100 g
    OXYBENZONE (OXYBENZONE) OXYBENZONE 4 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    ALKYL (C12-15) BENZOATE  
    DIMETHICONE  
    GLYCERYL MONOSTEARATE  
    HYDRATED SILICA  
    PEG-100 STEARATE  
    SODIUM POLYACRYLATE (2500000 MW)  
    BENZYL ALCOHOL  
    PHENOXYETHANOL  
    EDETATE DISODIUM  
    IODOPROPYNYL BUTYLCARBAMATE  
    PEG-8 DIMETHICONE  
    ALOE VERA LEAF  
    OCTYLDODECANOL  
    VITAMIN A PALMITATE  
    SILICON DIOXIDE  
    .ALPHA.-TOCOPHEROL ACETATE  
    ASCORBIC ACID  
    METHYLPARABEN  
    PROPYLPARABEN  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67732-412-55 184 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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