Label: DUANE READE PREVAIL MOISTURIZING SUNSCREEN SPF 50- avobenzone lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 November 14, 2012

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  • ACTIVE INGREDIENTS:

    Avobenzone 2.0 %

    Octocrylene 8.0 %

    Oxybenzone 4.0%

  • Purpose

    Sunscreen

  • USES:

    • Helps prevent sunburn
    • Higher SPF gives more sunburn protection
    • Retains SPF after 80 minutes of activity in the water
  • 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.

  • 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.
  • 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.
  • 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.

  • 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

  • INGREDIENTS AND APPEARANCE
    DUANE READE PREVAIL MOISTURIZING SUNSCREEN  SPF 50
    avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67732-412
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67732-412-55184 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/14/2012
    Labeler - DUANE READE INC. (011988995)
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