DUANE READE BABY SUNSCREENSPF 50 SPF 50 (AVOBENZONE) LOTION [DUANE READE INC.]

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DUANE READE BABY SUNSCREENSPF 50 SPF 50 (AVOBENZONE) LOTION [DUANE READE INC.]
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NDC 67732-401-16
Set ID 5e017f81-9f3b-4feb-9b7a-52b3a2420b54
Category HUMAN OTC DRUG LABEL
Packager DUANE READE INC.
Generic Name
Product Class
Product Number
Application Number PART352
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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 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

    baby

    SUNSCREEN

    50

    SPF

    pediatrician tested

    UVA/UVB Protection

    Very Water Resistant

    Moisturizing Lotion

    8 FL OZ (237 mL)label1.jpg

  • INGREDIENTS AND APPEARANCE
    DUANE READE BABY SUNSCREENSPF 50   SPF 50
    avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67732-401
    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:67732-401-16226 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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