Label: ULTRA COLOR RICH MOISTURE SEDUCTION- octinoxate lipstick

  • 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 December 14, 2010

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  • DOSAGE & ADMINISTRATION

    DIRECTIONS:Apply liberally
    before sun exposure and as needed.

  • WARNINGS

    WARNING: Discontinue
    use if skin irritation develops or
    increases. If irritation persists,
    consult a health care practitioner.

  • INDICATIONS & USAGE

    Uses: Helps prevent sunburn. Higher SPF
    gives more sunburn protection.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT/INGRÉDIENT ACTIF:
    OCTINOXATE 7.5%

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS/INGRÉDIENTS INACTIFS:
    DIISOSTEARYL FUMARATE, BARIUM SULFATE,SQUALANE, POLYBUTENE, DIISOPROPYL DIMER DILINOLEATE,
    OZOKERITE, MICROCRYSTALLINE WAX/
    CIRE MICROCRISTALLINE, POLYGLYCERYL-2 DIISOSTEARATE,
    LANOLIN, POLYETHYLENE, DI-C12-15
    ALKYL FUMARATE, PETROLATUM, CALCIUM SODIUM
    BOROSILICATE, ZEA MAYS (CORN) STARCH, ISOPROPYL
    ISOSTEARATE, STEARYL/PPG-3 MYRISTYL ETHER
    DIMER DILINOLEATE, SUCROSE ACETATE ISOBUTYRATE,
    CETYL ALCOHOL, SYNTHETIC FLUORPHLOGOPITE,
    SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL,
    ALOE BARBADENSIS LEAF EXTRACT, GLYCINE SOJA
    (SOYBEAN) OIL, RETINOL, HONEY EXTRACT/EXTRAIT
    DE MIEL, HYDROLYZED SILK, BIOTIN/FOLIC ACID/
    CYANOCOBALAMIN/NIACINAMIDE/PANTOTHENIC
    ACID/PYRIDOXINE/RIBOFLAVIN/THIAMINE/YEAST
    POLYPEPTIDES, TAMARINDUS INDICA SEED EXTRACT,
    PORTULACA OLERACEA EXTRACT, PHENYL TRIMETHICONE,
    POLYMETHYLSILSESQUIOXANE, CHOLESTERYL/
    BEHENYL/OCTYLDODECYL LAUROYL GLUTAMATE,
    SILICA, TOCOPHERYL ACETATE, GLYCERIN,
    CAPRYLYL GLYCOL, HYDROGENATED CASTOR OIL, BEHENYL
    ERUCATE, ALLANTOIN, ALLYL METHACRYLATES
    CROSSPOLYMER, ISOPROPYL TITANIUM TRIISOSTEARATE,
    LECITHIN, ACRYLATES COPOLYMER,
    PARFUM/ FRAGRANCE, BEESWAX/CIRE D'ABEILLE,
    PEG-80 SORBITAN LAURATE, ACRYLATES/CARBAMATE
    COPOLYMER, CALCIUM PCA, ETHYLENE/PROPYLENE/
    STYRENE COPOLYMER, C12-15 ALKYL BENZOATE,
    HYALURONIC ACID, WATER/EAU, COLLAGEN, ETHYLHEXYL
    PALMITATE, HYDROXYETHYL UREA, TRIBEHENIN,
    BUTYLENE/ETHYLENE/STYRENE COPOLYMER,
    RETINYL PALMITATE, LAUROYL LYSINE, PENTYLENE
    GLYCOL, SORBITAN ISOSTEARATE, UREA, PHENOXYETHANOL,
    ASCORBYL PALMITATE, BETA-CAROTENE,
    PALMITOYL OLIGOPEPTIDE. MAY CONTAIN/PEUT CONTENIR:
    MICA/CI 77019, BISMUTH OXYCHLORIDE/CI
    77163, TITANIUM DIOXIDE/CI 77891, IRON OXIDES/CI
    77489/CI77491/CI 77492/CI 77499, RED 7 LAKE/
    C15850, YELLOW 5 LAKE/CI 19140, RED 33 LAKE/CI
    17200, RED 6/CI 15850, CARMINE/CI 75470, BLUE 1
    LAKE/CI 42090, ORANGE 5/CI 45370, RED 21 LAKE/CI
    45380, RED 21/CI 45380, RED 22 LAKE/CI 45380, RED
    27 LAKE/CI 45410, RED 28 LAKE/CI 45410, RED 30
    LAKE/CI 73360, YELLOW 10 LAKE/CI 47005, YELLOW
    6 LAKE/CI 15985, RED 40 LAKE/CI 16035.

  • PRINCIPAL DISPLAY PANEL

    PDPimage of label

  • INGREDIENTS AND APPEARANCE
    ULTRA COLOR RICH  MOISTURE SEDUCTION
    octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0229
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.225 g  in 3 g
    Inactive Ingredients
    Ingredient NameStrength
    SQUALANE (UNII: GW89575KF9)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    LANOLIN (UNII: 7EV65EAW6H)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SUCROSE ACETATE ISOBUTYRATE (UNII: H5KI1C3YTV)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    RETINOL (UNII: G2SH0XKK91)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    ALLANTOIN (UNII: 344S277G0Z)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    UREA (UNII: 8W8T17847W)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BETA CAROTENE (UNII: 01YAE03M7J)  
    PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
    MICA (UNII: V8A1AW0880)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10096-0229-13 g in 1 CASE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/14/2010
    Labeler - Avon Products, Inc. (001468693)