Label: MEIJER KIDS TEAR FREE SPF 50- avobenzone, homosalate, octisalate, octocrylene spray

  • NDC Code(s): 41250-928-55
  • Packager: Meijer Distribution, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 March 11, 2016

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  • Active ingredients

    Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 6.0%

  • 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

    Flammable:  Do not puncture or incinerate.  Contents under pressure.  Do not store at temperature above 1200F. Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking.

    Do not use

    on damaged or broken skin

    When using this product

    • Keep away from face to avoid breathing it.
    • 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.
    • Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
    • May stain some fabrics.
  • Directions

    • hold container 4-6 inches from the skin to apply
    • spray liberally and spread evenly by hand 15 minutes before sun exposure
    • Do not spray directly on face.  Spray on hands then apply to face.
    • do not apply in windy conditions
    • use in well-ventilated area
    • 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 production 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

    Isobutane, Water, Isohexadecane, Ethylhexyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Dibutyl Adipate, Lauryl PEG-8 Dimethicone, Ethylhexyl Methoxycrylene, Sodium Chloride, PEG-8, Caprylyl Glycol, Glycerin, Sodium Citrate, PEG-8 Dimethicone, Aloe Barbadensis Leaf Juice, Octyldodecanol, Retinyl Palmitate, Silica, Tocopheryl Acetate, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Phenoxyethanol, Methylparaben, Butylparaben, Ethylparaben, Isobutylparaben, Propylparaben.

  • Other information

    protect this product from excessing heat and direct sun

  • Questions or comments?

    Call 1-800-697-9868  Mon-Fri

  • Principal Display Panel

    NDC:  41250-928-55

    meijer

    tear free

    Kids Sunscreen

    continuous spray

    pediatrician tested

    UVA/UVB protection

    50+

    Broad Spectrum

    SPF 50+

    Water Resistant

    (80 minutes)

    NET WT 6 OZ.  (170 g)

    Label

  • INGREDIENTS AND APPEARANCE
    MEIJER KIDS TEAR FREE SPF 50 
    avobenzone, homosalate, octisalate, octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-928
    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) OCTISALATE5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOBUTANE (UNII: BXR49TP611)  
    WATER (UNII: 059QF0KO0R)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    2-ETHYLHEXYL BENZOATE (UNII: R63ZWW1A13)  
    DIBUTYL ADIPATE (UNII: F4K100DXP3)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    SODIUM PROPOXYHYDROXYPROPYL THIOSULFATE SILICA (UNII: 208G222332)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-928-55170 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/06/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/11/2016
    Labeler - Meijer Distribution, Inc. (006959555)
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