KIDS SUNSCREEN (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [KAREWAY PRODUCT, INC.]

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KIDS SUNSCREEN (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [KAREWAY PRODUCT, INC.]
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NDC 67510-0082-5
Set ID 6d99a7c2-7c49-410f-9c36-fe83213c8a76
Category HUMAN OTC DRUG LABEL
Packager Kareway Product, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • Active Ingredients

    Octyl Methoxycinnamate 7%

    Titanium Dioxide 2.8%

  • Purpose

    Sunscreen

    Sunscreen

  • Use

    helps prevent sunburn

  • Warnings

    Skin Cancer/Early Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

    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 call a Poison Control Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply:
      • after 40 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hours
    • children under 6 months: Ask a doctor
  • Other information

    • protect this product from excessive heat and direct sun
    • may stain fabrics
    • for Lot and Expiration Date, see crimp of tube
  • Inactive Ingredients

    Water, Glycerin, Glyceryl Stearate,

    PEG-100 Stearate, Stearic acid, Cetearyl Alcohol, Phenoxyethanol,

    Acrylates/C10-30 alkyl acrylate crosspolymer, Chlorphenesin,

    Triethanolamine, Lavandula Angustifolia (Lavender) Extract,

    Salvia Sclarea (Clary) Extract, Hyacinthus Orientalis Extract,

    Chamomilla Recutita (Matricaria) Flower/Leaf Extract, Borago

    officinalis Extract, Centaurea cyanus flower Extract, Dimethicone,

    Butylene Glycol, 1,2-Hexanediol, Ethylhexylglycerin, Disodium

    EDTA, Fragrance

  • Package label

    Pure Aid Kids Sunscreen Lotion

    tube

  • INGREDIENTS AND APPEARANCE
    KIDS SUNSCREEN 
    octinoxate and titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0082
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.8 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0082-5100 mL in 1 TUBE; Type 0: Not a Combination Product12/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/01/2011
    Labeler - Kareway Product, Inc. (121840057)
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