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Name:Age Defense Bb Creamspf 30
Manufacturer:Clinique Laboratories Inc
Category:Over-the-counter (OTC) Marketed Drugs


AGE DEFENSE BB CREAM SPF 30 - octinoxate, octisalate, zinc oxide, oxybenzone and titanium dioxide cream 
CLINIQUE LABORATORIES INC

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.

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

Apply daily all over face.

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

PRINCIPAL DISPLAY PANEL:

Clinique

Age Defense BB Cream

SPF 30

40ml   1.4Floz

Clinique Laboratories, Dist.

New York, NY 10022
../images_otc/age_defense__77jxcarton.jpg

FOLDING CARTON








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 DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE ) OCTINOXATE 7.5 mL  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE 4.0 mL  in 100 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 3.5 mL  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 2.5 mL  in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 1.1 mL  in 100 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49527-760-01 1 TUBE ( TUBE) in 1 CARTON contains a TUBE (49527-760-02)
1 NDC:49527-760-02 40 mL in 1 TUBE This package is contained within the CARTON (49527-760-01)

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 Operations
ESTEE LAUDER COSMETICS, LTD 205952385 manufacture
Establishment
Name Address ID/FEI Operations
ESTEE LAUDER N.V. 370151326 manufacture
Establishment
Name Address ID/FEI Operations
Len-Ron Manufacturing Division of Aramis Inc. 809771152 manufacture
Establishment
Name Address ID/FEI Operations
Aramis Inc. 042918826 manufacture
Establishment
Name Address ID/FEI Operations
Northtec Bristol 949264774 manufacture, relabel, repack
Establishment
Name Address ID/FEI Operations
Northtec Keystone 618107429 manufacture, relabel, repack
Establishment
Name Address ID/FEI Operations
PADC 1 110482184 manufacture, relabel, repack
Establishment
Name Address ID/FEI Operations
Estee Lauder Cosmetics, Ltd. 255175580 manufacture
Establishment
Name Address ID/FEI Operations
Estee Lauder Cosmetics, Ltd 253616536 manufacture
Establishment
Name Address ID/FEI Operations
Estee Lauder Cosmetics Distribution Center 208579636 repack, relabel
Establishment
Name Address ID/FEI Operations
Estee Lauder Kabushiki Kaisha 712808195 relabel, repack
Establishment
Name Address ID/FEI Operations
Whitman Laboratories Ltd. 216866277 manufacture

Revised: 06/2010 CLINIQUE LABORATORIES INC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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