Label: AGE DEFENSE BB CREAM SPF 30- octinoxate, octisalate, zinc oxide, oxybenzone, titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL

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, 2010

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    OCTINOXATE 7.5%, OCTISALATE 4.0%, ZINC OXIDE 3.5%, OXYBENZONE 2.5%, TITANIUM DIOXIDE 1.1%

  • WHEN USING

    Apply daily all over face.

  • WARNINGS

    Keep out of eyes. Stop use if irritation occurs. Keep out of reach of children.

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL:

    Clinique

    Age Defense BB Cream

    SPF 30

    40ml   1.4Floz

    Clinique Laboratories, Dist.

    New York, NY 10022
    77jxcarton.jpg

    FOLDING CARTON







  • INGREDIENTS AND APPEARANCE
    AGE DEFENSE BB CREAM  SPF 30
    octinoxate, octisalate, zinc oxide, oxybenzone, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-760
    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) OCTISALATE4.0 mL  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.5 mL  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2.5 mL  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.1 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-760-011 in 1 CARTON
    1NDC:49527-760-0240 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/23/2010
    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
    PADC 1110482184manufacture, 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