REDNESS SOLUTIONS MAKEUP SPF 15 WITH PROBIOTIC TECHNOLOGY (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [CLINIQUE LABORATORIES INC]

REDNESS SOLUTIONS MAKEUP SPF 15 WITH PROBIOTIC TECHNOLOGY (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [CLINIQUE LABORATORIES INC]
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NDC 49527-005-01, 49527-005-02
Set ID 361d7f45-22f4-440f-b9e6-312618e48298
Category HUMAN OTC DRUG LABEL
Packager CLINIQUE LABORATORIES INC
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    active ingredients: octinoxate 5.90% [] titanium dioxide 3.70% [] zinc oxide 2.90%

  • INACTIVE INGREDIENT


    inactive ingredients: water [] methyl trimethicone [] phenyl trimethicone [] dimethicone [] triethylhexanoin [] butylene glycol [] trimethylsiloxysilicate [] peg-10 dimethicone [] lauryl peg-9 polydimethylsiloxyethyl dimethicone [] aluminum hydroxide [] c12-15 alkyl benzoate [] lactobacillus ferment [] citrus grandis (grapefruit) peel extract [] magnolia grandiflora bark extract [] poria cocos sclerotium extract [] astrocaryum murumuru seed butter [] glycerin [] caffeine [] sodium myristoyl sarcosinate [] caprylyl methicone [] methicone [] polyglyceryl-6 polyricinoleate [] disteardimonium hectorite [] acetyl glucosamine [] isopropyl titanium triisostearate [] dimethicone crosspolymer-3 [] lecithin [] tocopheryl acetate [] laureth-7 [] dimethicone/peg-10/15 crosspolymer [] sodium chloride [] dipropylene glycol [] disodium edta [] polyaminopropyl biguanide [] phenoxyethanol []  [+/- mica [] titanium dioxide (ci 77891) [] iron oxides (ci 77491, ci 77492, ci 77499)]

  • WARNINGS

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

  • PRINCIPAL DISPLAY PANEL

    principal display panel:

    CLINIQUE

    REDNESS

    SOLUTIONS

    MAKE UP SPF 15

    with probiotic technology

    1 fl oz liq/ 30 ml


    clinique laboratories, dist

    new york, ny 10022

    folding carton


  • INGREDIENTS AND APPEARANCE
    REDNESS SOLUTIONS MAKEUP  SPF 15 WITH PROBIOTIC TECHNOLOGY
    octinoxate, titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5.9 mL  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.7 mL  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.9 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)  
    TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    LACTOBACILLUS HELVETICUS (UNII: Q08Z44662J)  
    CITRUS MAXIMA FRUIT RIND (UNII: 5NX3G75CA6)  
    MAGNOLIA GRANDIFLORA BARK (UNII: J4XF5T6418)  
    FU LING (UNII: XH37TWY5O4)  
    ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAFFEINE (UNII: 3G6A5W338E)  
    SODIUM MYRISTOYL ISETHIONATE (UNII: 8D42TA2T6V)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LAURETH-7 (UNII: Z95S6G8201)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-005-011 in 1 CARTON
    1NDC:49527-005-0230 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/01/2010
    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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