WALGREENS SUN KIDS SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [WALGREEN COMPANY]

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WALGREENS SUN KIDS SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [WALGREEN COMPANY]
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NDC 0363-9921-26
Set ID c75f3010-d399-492b-910e-6552ba75bc1b
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    1491-25 Rev 00

    Walgreens Kids Sunscreen Lotion

  • Active Ingredients

    Avobenzone 3%, Homosalate 10%, Octocrylene 8%, Octisalate 4.5%  

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  • Warnings

    For external use only

    Do not use

    on damaged or broken skin

    When using this product

    keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor

    if rash occurs

    Keep out of reach of children.

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

  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply:
      • after 80 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hours
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including:
      • limit time in the sun, especially from 10 a.m. - 2 p.m.
      • wear long-sleeve shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor
  • Inactive Ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aloe Barbadensis Leaf Juice, C28-52 Olefin/Undecylenic Acid , Caprylyl Glycol, Cetearyl Alcohol, Diisopropyl Adipate, Dimethicone, Disodium EDTA, Fragrance, Glycerin, Glyceryl Stearate, Hydrogenated Palm Glycerides, Neopentyl Glycol Diheptanoate, PEG 100 Stearate, Phenethyl Benzoate, Polyglyceryl-3 Methylglucose Distearate, Phenoxyethanol, Potassium Cetyl Phosphate, Sodium Hydroxide, Tapioca Starch Polymethylsilsesquioxane, Tocopherol Acetate, Trisiloxane, Water, Xanthan Gum

  • Other Information

    • for use on skin only. Avoid contact with fabric
    • protect this product from excessive heat and direct sun
  • Questions or comments?

    www.walgreens.com or call toll free 1-800-XXX-XXXX

  • PRINCIPAL DISPLAY PANEL

    50
    Kids
    Broad Spectrum SPF 50
    Sunscreen UVA/UVB
    Dye Free
    Oxybenzone Free
    3 FL OZ (88 mL)

    PRINCIPAL DISPLAY PANEL 50 Kids Broad Spectrum SPF 50 Sunscreen UVA/UVB Dye Free Oxybenzone Free 3 FL OZ (88 mL)

  • INGREDIENTS AND APPEARANCE
    WALGREENS SUN KIDS SPF50 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9921
    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) HOMOSALATE10 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    PHENETHYL BENZOATE (UNII: 0C143929GK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9921-2689 g in 1 BOTTLE; Type 0: Not a Combination Product11/15/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35211/15/2017
    Labeler - Walgreen Company (008965063)
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