Label: DUANE READE SUNSCREEN SPF 15- octinoxate 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

    Octinoxate 7.5%

    Oxybenzone 4.5%

  • 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

    • shake well
    • apply generously 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, Sorbitan Oleate, Glyceryl Stearate SE, Hydrogenated Vegetable oil Isopropyl Myristate, Triethanolamine,VP/Eicosene Copolymer, Benzyl Alcohol, Imadazolidinyl Urea, Methylparaben, Dimethicone,Carbomer, Fragrance,Simmondsia Chinensis(Jojoba) Seed Oil, Propylparaben, Tocopherol, Aloe Barbadensis Leaf Juice, Disodium EDTA.

  • Principal Display Panel

    UNIQUELY NY DRTM SINCE 1960

    SUNSCREEN

    15

    SPF

    moisturizing lotion

    UVA/UVB Protection

    Very water resistant

    8 FL OZ (237 mL)label.jpg

  • INGREDIENTS AND APPEARANCE
    DUANE READE SUNSCREEN  SPF 15
    octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67732-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 4.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    IMIDUREA (UNII: M629807ATL)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    JOJOBA OIL (UNII: 724GKU717M)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67732-400-16226 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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