CX DAILY EYE PROTECTOR SPF 15 (TITANIUM DIOXIDE) GEL [CLINIQUE LABORATORIES INC]

CX DAILY EYE PROTECTOR SPF 15 (TITANIUM DIOXIDE) GEL [CLINIQUE LABORATORIES INC]
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NDC 49527-750-01, 49527-750-02
Set ID e6f428cc-3d6f-43a4-a893-0453ec1f4c59
Category HUMAN OTC DRUG LABEL
Packager CLINIQUE LABORATORIES INC
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    active ingredient: titanium dioxide 7.80%

  • INACTIVE INGREDIENT

    inactive ingredients: cyclopentasiloxane [] dimethicone [] trioctyldodecyl citrate [] silica [] isododecane [] vinyl dimethicone/methicone silsesquioxane crosspolymer [] dimethicone/vinyl dimethicone crosspolymer [] trimethylsiloxysilicate [] polysilicone-11 [] aluminum stearate [] mimosa tenuiflora bark extract [] tocopheryl acetate [] vitis vinifera (grape) seed oil [] 7-dehydrocholesterol [] tricaprylin [] tetrahexyldecyl ascorbate [] butylene glycol [] water\aqua\eau [] tocotrienols [] aminopropyl ascorbyl phosphate [] stearic acid [] methicone [] phenoxyethanol [] mica [] iron oxides (ci 77491, ci 77492, ci 77499) [] titanium dioxide (ci 77891)

  • WARNINGS

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

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL FOR OTC SUNSCREEN PRODUCT INCLUDED IN SET. SET ALSO CONTAINS A COSMETIC PRODUCT:


    CLINIQUE


    CX

    24 HOUR EYE DE-AGING SYSTEM

    DAILY EYE PROTECTOR

    SPF 15



    CLINIQUE LABORATORIES, INC

    NEW YORK, NY 10022

    FOLDING CARTON

  • INGREDIENTS AND APPEARANCE
    CX DAILY EYE PROTECTOR  SPF 15
    titanium dioxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-750
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7.8 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRICAPRYLYL CITRATE (UNII: BXW1GAI4TA)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ISODODECANE (UNII: A8289P68Y2)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    MIMOSA TENUIFLORA BARK (UNII: 515MQE449I)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)  
    TRICAPRYLIN (UNII: 6P92858988)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-750-011 in 1 CARTON
    1NDC:49527-750-027 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/2002
    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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