Label: KROGER KIDS TEAR FREE SPF50- avobenzone, homosalate, octisalate, octocrylene spray

  • 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 January 5, 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 temperatures 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,


    • May stain some fabrics.
    • Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
  • 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 on face.
    • do not apply in windy condition
    • 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 broad spectrum SPF of 15 or higher and other sun protection measures including


    • limit time in the sun especially from 10.00 a.m. - 2.00 p.m.
    • wear long-sleeve 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 excessive heat and direct sun
  • Questions or Comments?

    Call 1-800-632-6900

  • Principal Display Panel


    NDC 30142-655-34

    Kroger

    FROM OUR FAMILY

    TO YOURS

    KIDS

    sunscreen

    50+

    Broad Spectrum SPF 50+


    • Continuous Spray
    • Water Resistant (80 Minutes)
    • Quick and Even Coverage
    • Hypoallergenic

    Tear Free

    NET WT. 6 OZ. (170g)


    Label






  • INGREDIENTS AND APPEARANCE
    KROGER KIDS TEAR FREE SPF50  
    avobenzone, homosalate, octisalate, octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-655
    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) OCTOCRYLENE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOBUTANE (UNII: BXR49TP611)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    2-ETHYLHEXYL BENZOATE (UNII: R63ZWW1A13)  
    DIBUTYL ADIPATE (UNII: F4K100DXP3)  
    WATER (UNII: 059QF0KO0R)  
    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:30142-655-34170 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/05/2016
    Labeler - Kroger Company (006999528)
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