Label: REPAIRWEAR LASERFOCUS ALL SMOOTH MAKEUP SPF 15- titanium dioxide, octocrylene lotion

  • 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 June 23, 2011

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  • ACTIVE INGREDIENT

    active ingredients: titanium dioxide 2.90% [] octocrylene 2.00%

  • INACTIVE INGREDIENT

    inactive ingredients: water [] methyl trimethicone [] phenyl trimethicone [] dimethicone [] triethylhexanoin [] butylene glycol [] trimethylsiloxysilicate [] peg-10 dimethicone [] lauryl peg-9 polydimethylsiloxyethyl dimethicone [] glycerin [] alumina [] astrocaryum murumuru seed butter [] whey protein\lactis protein\protéine du petit-lait [] sigesbeckia orientalis (st. paul's wort) extract [] micrococcus lysate [] acetyl hexapeptide-8 [] sodium hyaluronate [] palmitoyl oligopeptide [] sodium myristoyl sarcosinate [] dimethicone/peg-10/15 crosspolymer [] sodium chloride [] tocopheryl acetate [] acetyl glucosamine [] glyceryl polymethacrylate [] methicone [] disteardimonium hectorite [] lecithin [] dimethicone crosspolymer-3 [] peg-8 [] laureth-7 [] dipropylene glycol [] disodium edta [] polyaminopropyl biguanide [] phenoxyethanol []  [+/- mica [] titanium dioxide (ci 77891) [] iron oxides (ci 77491, ci 77492, ci 77499) [] bismuth oxychloride (ci 77163)]

  • WARNINGS

    warning: keep out of eyes. stop use if irritation occurs. keep out of reach of children

  • PRINCIPAL DISPLAY PANEL

    principal display panel:


    CLINIQUE

    REPAIRWEAR

    LASERFOCUS

    ALL SMOOTH MAKEUP

    SPF 15


    1 FL OZ LIQ/30 ML



    CLINIQUE LABORATORIES INC DIST
    NEW YORK, NY 10022
    FOLDING CARTON






  • INGREDIENTS AND APPEARANCE
    REPAIRWEAR  LASERFOCUS ALL SMOOTH MAKEUP SPF 15
    titanium dioxide, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.9 mL  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.0 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
    WHEY (UNII: 8617Z5FMF6)  
    ACETYL HEXAPEPTIDE-3 (UNII: L4EL31FWIL)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
    SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y)  
    LAURETH-7 (UNII: Z95S6G8201)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-011-011 in 1 CARTON
    1NDC:49527-011-0230 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/2011
    Labeler - CLINIQUE LABORATORIES INC (173047747)
    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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