WALGREENS BABY SPF50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [WALGREEN COMPANY]

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WALGREENS BABY SPF50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [WALGREEN COMPANY]
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NDC 0363-9926-20
Set ID cd56a2d6-ec92-4670-975b-3da28037773c
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    1491-23(V) Rev 01

    Walgreen Baby SPF 50 Lotion

  • Active Ingredients

    Titanium Oxide 3.30%, Zinc Oxide 4.2%

  • 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

    Deionized Water, Caprylic/Capric Triglycerides, Tridecyl Neopentanoate, Sorbitol, Cetyl PEG/PPG 10/1 Dimethicone, Butly Octyl Salicylate, Glycerin, Octyldodecyl Citrate Copolymer, C28-52 Olefin/Undecylenic Acid Copolymer, PEG 8, Dimethicone, Aloe Barbadensis Leaf Juice, Ethylhexyl Methoxycrylene, Tocopherol Acetate, Lauryl PEG-8 Dimethicone, Caprylyl Glycol, Sodium Chloride, Phenoxyethanol, Sodium Citrate

  • 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-XX-XXXX

  • PRINCIPAL DISPLAY PANEL

    Walgreens
    50
    Baby
    Broad spectrum SPF 50
    Sunscreen UVA/UVB
    HYPOALLERGENIC
    OXYBENZONE FREE
    TEAR FREE
    3 FL OZ (88 ML)

    PRINCIPAL DISPLAY PANEL Walgreens 50 Baby Broad spectrum SPF 50 Sunscreen UVA/UVB HYPOALLERGENIC OXYBENZONE FREE TEAR FREE 3 FL OZ (88 ML)

  • INGREDIENTS AND APPEARANCE
    WALGREENS BABY SPF50 
    titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9926
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.1 mg  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    TRIDECYL NEOPENTANOATE (UNII: 3Z8H1DA7J5)  
    SORBITOL (UNII: 506T60A25R)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3) (UNII: G300307ZXP)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYOXYL 8 STEARATE (UNII: 2P9L47VI5E)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9926-2089 mL in 1 BOTTLE; Type 0: Not a Combination Product08/25/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35208/25/2017
    Labeler - Walgreen Company (008965063)
    Registrant - Walgreen Company (008965063)
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