Label: BEYOND COLOR PLUMPING LIPCOLOR- octinoxate lipstick

  • 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 February 9, 2013

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  • ACTIVE INGREDIENT

    Active ingredient
    Octinoxate 7.5%................................

    Purpose
    ...............................Sunscreen

  • INDICATIONS & USAGE

    Uses
    • helps prevent sunburn

  • WARNINGS

    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 help 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 swallowed, get medical help or contact a poison control center right away.

  • DOSAGE & ADMINISTRATION

    Directions
    • apply liberally 15 minutes before sun exposure
    • children under 6 months of age: ask a doctor
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating

  • STORAGE AND HANDLING

    Other information
    • protect the product in this container from excessive heat and direct sun

  • INACTIVE INGREDIENT

    Inactive ingredients:Diisostearyl Fumarate, Squalane, Polybutene, Barium Sulfate, Ozokerite, Microcrystalline Wax/Cire Microcristalline, DI-C12-15 Alkyl Fumarate, Polyethylene, Zea Mays (Corn) Starch, Petrolatum, Calcium Sodium Borosilicate, Silica, Beeswax/Cire D’Abeille,
    Tocopheryl Acetate, Caprylyl Glycol, Cholesteryl/Behenyl/Octyldodecyl Lauroyl Glutamate, Glycerin, Hydrogenated Castor Oil, Behenyl Erucate, Lauroyl Lysine, Allantoin, Aloe Barbadensis Leaf Extract, Allyl Methacrylates Crosspolymer, Lecithin, Acrylates Copolymer, Parfum/Fragrance, Phenyl Trimethicone, Glycine Soja (Soybean) Oil, Retinol, PEG-80 Sorbitan Laurate, Acrylates/Carbamate Copolymer, C12-15 Alkyl Benzoate, Cetyl Alcohol, Collagen, Ethylhexyl Palmitate, Hyaluronic Acid, Biotin/Folic Acid/Cyanocobalamin/Niacinamide/Pantothenic Acid/Pyridoxine/Riboflavin/Thiamine/Yeast Polypeptides, Tribehenin, Retinyl Palmitate, Sorbitan Isostearate, Ascorbyl Palmitate, Beta-Carotene, Palmitoyl Oligopeptide. Sparkle Shades May Also Contain: Tin Oxide. May Contain: Mica/CI 77019, Iron Oxides, Red 7 Lake/CI 15850, Titanium Dioxide/CI 77891, Red 6 Lake/CI 15850, Bismuth Oxychloride/CI 77163, Red 33 Lake/CI 17200, Yellow 5 Lake/CI 19140, Yellow 6 Lake/CI 15985, Blue 1 Lake/CI 42090, Red 27 Lake/CI 45410, Carmine/CI 75470, Red 6/CI 15850, Orange 5/CI 45370, Red 21 Lake/CI 45380, Red 21/CI 45380, Red 22 Lake/CI 45380, Red 28 Lake/CI 45410, Red 30 Lake/CI 73360, Yellow 10 Lake/CI 47005, Red 40 Lake/CI 16035.

  • QUESTIONS

    Questions or Comments?
    Call toll free 1-800-FOR-AVON or 1-800-265-AVON
    in Canada

  • PRINCIPAL DISPLAY PANEL

    image of PDPimage of cartonimage of cartonimage of carton

  • INGREDIENTS AND APPEARANCE
    BEYOND COLOR  PLUMPING LIPCOLOR
    octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0038
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10096-0038-21 in 1 CARTON
    1NDC:10096-0038-13.6 g in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/09/2013
    Labeler - Avon Products, Inc (001468693)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avon Cosmetics Manofacturing, S. de R.L. de C.V.815033493manufacture(10096-0038)
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