Label: MEIJER KIDS TEAR FREE SPF 50- titanium dioxide, zinc oxide lotion

  • NDC Code(s): 41250-922-57
  • Packager: Meijer Distribution, Inc.
  • Category: HUMAN OTC DRUG LABEL

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 June 2, 2016

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  • Active ingredients

    Titanium Dioxide  3.2%, Zinc Oxide 4.0%

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

    • May stain some fabrics
  • 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. to 2 p.m.
    • wear long-sleeved shirts, pants, hats and sunglasses
    • children under 6 months of age: Ask a doctor

  • Inactive ingredients

    Water, Caprylic/Capric Triglyceride, Isohexadecane, Butyloctyl Salicylate, Octyldodecyl Citrate Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Sodium Chloride, Ethylhexyl Methoxycrylene, Dimethicone, Phenoxyethanol, Caprylyl Glycol, PEG-8, Alumina, Glycerin, Sodium Citrate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

  • Other information

    protect this product from excessive heat and direct sun

  • Questions or comments?

    Call 1-800-697-9868 Mon-Fri

  • Principle Display Label

    NDC:  41250-922-57

    meijer

    tear free

    kids

    Sunscreen lotion

    pediatrician tested

    UVA/UVB protection

    50

    Broad Spectrum

    SPF 50

    Water Resistant

    (80 minutes)

    1 FL. OZ. (295 mL)

    Label

  • INGREDIENTS AND APPEARANCE
    MEIJER KIDS TEAR FREE SPF 50 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-922
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.2 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-922-57295 g in 1 BOTTLE; Type 0: Not a Combination Product06/02/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/02/2016
    Labeler - Meijer Distribution, Inc. (006959555)
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