Label: DUANE READE SUNSCREEN SPF 70- avobenzone lotion

  • Category: HUMAN OTC DRUG LABEL

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 3.0 %

    Homosalate 15.0%

    Octisalate 5.0%

    Octocrylene 10.0%

    Oxybenzone 6.0%

  • 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 reach of children.

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

  • Directions

    • shake well
    • 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
  • Other Information

    • may stain some materials
    • Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin agin, skin cancer, and other harmful effects of the sun.
  • Inactive Ingredients

    Water, Glyceryl Stearate, Microcrystalline Cellulose, Butylene Glcyol, PEG_100 Stearate, Benzyl Alcohol, Acrylates/C12-22 Alkyl Methcrylate Copolymer, Diethylhexyl Syringylidenemalonate, Behenyl Alcohol, Butylated PVP, Palmitic Acid, Lecithin, Stearic Acid, Cellulose Gum, Myristyl Alcohol, Caprylic/Capric Triglyceride, Tocopherol, Retinyl Palmitate, Disodium EDTA, Sodium Ascorbyl Phosphate, Cetyl Alcohol, Lauryl Alcohol, Chlorphenesin.

  • Principal Display Panel

    UNIQUELY NY DRTM SINCE 1960

    sunscreen

    70

    SPF

    moisturizing lotion

    Photostable

    Broad Spectrum

    UVA/UVB Protection

    Very Water Resistant

    8 FL.OZ.(237 mL)ZDR013A0f.jpgZDR013A0b.jpg

  • INGREDIENTS AND APPEARANCE
    DUANE READE SUNSCREEN  SPF 70
    avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67732-409
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    TRICAPRYLIN (UNII: 6P92858988)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    LAURYL ALCOHOL (UNII: 178A96NLP2)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67732-409-16226 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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