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

  • NDC Code(s): 49527-760-01, 49527-760-02
  • Packager: CLINIQUE LABORATORIES INC
  • 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, 2010

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  • ACTIVE INGREDIENT

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

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  • WHEN USING

    Apply daily all over face.

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  • WARNINGS

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

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  • 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







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  • INGREDIENTS AND APPEARANCE
    AGE DEFENSE BB CREAM  SPF 30
    octinoxate, octisalate, zinc oxide, oxybenzone, titanium dioxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-760
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.0 mL  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 3.5 mL  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2.5 mL  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.1 mL  in 100 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49527-760-01 1 in 1 CARTON
    1 NDC:49527-760-02 40 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 08/23/2010
    Labeler - CLINIQUE LABORATORIES INC (173047747)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD 205952385 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER N.V. 370151326 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Len-Ron Manufacturing Division of Aramis Inc. 809771152 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Aramis Inc. 042918826 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Northtec Bristol 949264774 manufacture, relabel, repack
    Establishment
    Name Address ID/FEI Business Operations
    Northtec Keystone 618107429 manufacture, relabel, repack
    Establishment
    Name Address ID/FEI Business Operations
    PADC 1 110482184 manufacture, relabel, repack
    Establishment
    Name Address ID/FEI Business Operations
    Estee Lauder Cosmetics, Ltd. 255175580 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Estee Lauder Cosmetics, Ltd 253616536 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Estee Lauder Cosmetics Distribution Center 208579636 repack, relabel
    Establishment
    Name Address ID/FEI Business Operations
    Estee Lauder Kabushiki Kaisha 712808195 relabel, repack
    Establishment
    Name Address ID/FEI Business Operations
    Whitman Laboratories Ltd. 216866277 manufacture
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