Label: TINTED LIP CONDITIONER SPF 15- octinoxate, octisalate gel

  • 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 September 12, 2011

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS: OCTINOXATE 7.50% [] OCTISALATE 5.00%

  • INACTIVE INGREDIENT


    INACTIVE INGREDIENTS: PETROLATUM [] RICINUS COMMUNIS (CASTOR) SEED OIL [] POLYBUTENE [] MICROCRYSTALLINE WAX \CERA MICROCRISTALLINA\CIRE MICROCRISTALLINE [] ETHYLENE/PROPYLENE/STYRENE COPOLYMER [] HYDROGENATED POLYISOBUTENE [] FRAGRANCE (PARFUM) [] SILICA [] BUTYROSPERMUM PARKII (SHEA BUTTER) [] PERSEA GRATISSIMA (AVOCADO) OIL UNSAPONIFIABLES [] TRITICUM VULGARE (WHEAT) GERM OIL [] CHAMOMILLA RECUTITA (MATRICARIA) FLOWER OIL [] ASTROCARYUM MURUMURU BUTTER [] PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL [] TOCOPHERYL ACETATE [] RETINYL PALMITATE [] CHOLESTEROL [] LECITHIN [] SQUALANE [] POLYETHYLENE [] POLYDECENE [] BUTYLENE/ETHYLENE/STYRENE COPOLYMER [] TRIETHOXYCAPRYLYLSILANE [] TETRAHEXYLDECYL ASCORBATE [] SACCHARIN [] VANILLIN [] BHT

  • WARNINGS

    WARNING: STOP USE IF IRRITATION OCCURS.

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL:


    MAC

    LIP CONDITIONER SPF 15


    15 ML/0.5 US FL OZ.



    DISTR. BY MAKEUP ART COSMETICS
    TORONTO, ONTARIO, CANADA, M5V 1R7


    folding carton


  • INGREDIENTS AND APPEARANCE
    TINTED LIP CONDITIONER  SPF 15
    octinoxate, octisalate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40046-0049
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.0 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYISOBUTYLENE (35000 MW) (UNII: 98553S1MHQ)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    WHEAT GERM OIL (UNII: 14C97E680P)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    SACCHARIN (UNII: FST467XS7D)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:40046-0049-11 in 1 CARTON
    1NDC:40046-0049-215 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/01/2010
    Labeler - MAKEUP ART COSMETICS (010597206)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD205952385manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER N.V.370151326manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Aramis Inc.042918826manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec Bristol949264774manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec Keystone618107429manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics, Ltd.255175580manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics, Ltd253616536manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Distribution Center208579636repack, relabel
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Kabushiki Kaisha712808195relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Whitman Laboratories Ltd.216866277manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Aveda Corporation071352058manufacture
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