BABY SUNSCREEN SPF 50 (TITANIUM DIOXIDE 3.1% ZINC OXIDE 4.0%) LOTION [MEIJER]

BABY SUNSCREEN SPF 50 (TITANIUM DIOXIDE 3.1% ZINC OXIDE 4.0%) LOTION [MEIJER]
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NDC 41250-902-06
Set ID 1eae935f-942b-4290-91de-8c608f70a7ed
Category HUMAN OTC DRUG LABEL
Packager Meijer
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active ingredients                                                               Purpose
    Titanium Dioxide 3.1%........................................................Sunscreen
    Zinc Oxide 4.0%..................................................................Sunscreen

  • PURPOSE

  • INDICATIONS & USAGE

    Uses • helps prevent sunburn

  • WARNINGS

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

  • KEEP OUT OF REACH OF CHILDREN

  • DOSAGE & ADMINISTRATION

    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

  • OTHER SAFETY INFORMATION

    Other information • protect the product in this container from
    excessive heat and direct sun • may stain fabrics.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Aloe Barbadensis Leaf Extract, Alumina,
    Butyloctyl Salicylate, Caprylic/ Capric Triglyceride Caprylyl Glycol Cetyl
    PEG/PPG-10/1 Dimethicone, Dimethicone Ethylhexyl Methoxycrylene,
    Glycerin, Isohexadecane, Lauryl PEG-8 Dimethicone Octyldodecyl
    Citrate Crosspolymer PEG-8, Phenoxyethanol
    Sodium Chloride, Sodium Citrate, Tocopheryl
    Acetate, Triethoxycaprylylsilane, VP/Eicosene
    Copolymer Water.

  • Questions? 866-483-2846

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BABY SUNSCREEN SPF 50 
    titanium dioxide 3.1% zinc oxide 4.0% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-902
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide3.1 g  in 100 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Ethylhexyl Methoxycrylene (UNII: S3KFG6Q5X8)  
    Glycerin (UNII: PDC6A3C0OX)  
    Isohexadecane (UNII: 918X1OUF1E)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-902-06296 mL in 1 BOTTLE; Type 0: Not a Combination Product03/14/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/14/2017
    Labeler - Meijer (006959555)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(41250-902) , label(41250-902)

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