Label: DUANE READE 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 13, 2012

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  • Active Ingredients

    Avobenzone 3.0 %

    Homosalate 13.0%

    Octisalate 5.0%

    Octocrylene 7.0%

    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 reach of children.

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

    Other Information

    • may stain some materials.
  • Directions

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

    Water, Stearic Acid, Sorbitol,Triethanolamine,VP/Eicosene Copolymer, Aluminium Starch Octenylsuccinate, Benzyl Alcohol, Sorbitan Isostearate, Dimethicone, Polyglyceryl-3 Diastearate, Fragrance, Methylparaben, Carbomer, Tocopherol, Propylparaben, Disodium EDTA

  • Principal Display Panel

    UNIQUELY NY DRTM SINCE 1960

    sunscreen

    50

    SPF

    moisturizing lotion

    Broad Spectrum Protection

    Very Water Resistant


    8 FL OZ (237 mL)ZDR001B0.jpg

  • INGREDIENTS AND APPEARANCE
    DUANE READE SUNSCREEN  SPF 50
    avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67732-403
    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) HOMOSALATE13 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67732-403-16226 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/13/2012
    Labeler - DUANE READE INC. (011988995)
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