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

FACE AND BODY SUNSCREEN (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [KAREWAY PRODUCT, INC.]
PDF | XML

NDC 67510-0081-5
Set ID 4b8e46ab-134d-4c57-8018-7f441cf6d565
Category HUMAN OTC DRUG LABEL
Packager Kareway Product, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    Octyl Methoxycinnamate 7%

    Titanium Dioxide 2.8%

    Close
  • Purpose

    Sunscreen

    Sunscreen

    Close
  • Use

    helps prevent sunburn

    Close
  • Warnings

    Skin Cancer/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.

    Close
  • 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
    Close
  • Other information

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

    Water, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Stearic acid, Ceyearyl Alcohol, Phenoxyethanol, Acrylates/C10-30 Alkyl acrylate crosspolymer, Chlorphenesin, Triethanolamine, Lavandula Angustifolia (Lavender) Extract, Chamomilla Recutita (Matricaria) Flower/Leaf Extract, Borago officinalis Extract, Centaurea cyanus flower Extract, Dimethicone, Butylene Glycol, 1,2-Hexanediol, Ethylhexylglycerin, Disodium EDTA, Fragrance

    Close
  • Package label

    Face and Body Sunscreen

    tube

    Close
  • INGREDIENTS AND APPEARANCE
    FACE AND BODY SUNSCREEN 
    octinoxate and titanium dioxide lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:67510-0081
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.8 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67510-0081-5 100 mL in 1 TUBE; Type 0: Not a Combination Product 01/24/2013
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 01/24/2013
    Labeler - Kareway Product, Inc. (121840057)
    Close

Related Drugs