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Name:Brightening Spot Treatment Correctorspf 25
Manufacturer:Bobbi Brown Professional Cosmetics Inc
Category:Over-the-counter (OTC) Marketed Drugs


BRIGHTENING SPOT TREATMENT CORRECTOR SPF 25 - octinoxate and titanium dioxide cream 
Bobbi Brown Professional Cosmetics 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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ACTIVE INGREDIENTS: OCTINOXATE 7.0% [] TITANIUM DIOXIDE 0.98%

USAGE: DAB A SMALL AMOUNT DIRECTLY ONTO SPOT WITH PRECISION APPLICATOR. BLEND INTO SKIN WITH A BRUSH.

WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN.



PRINCIPAL DISPLAY PANEL:

BOBBI BROWN   

BRIGHTENING

SPOT

TREATMENT

CORRECTOR

SPF 25

0.16 OZ/ 4.5 ML


BOBBI BROWN PROFESSIONAL COSMETICS INC

600 MADISON AVE

NEW YORK, NY 10022

folding carton


BRIGHTENING SPOT TREATMENT CORRECTOR  SPF 25
octinoxate, titanium dioxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:64141-003
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 7 mL  in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 0.98 mL  in 100 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64141-003-01 1 TUBE, WITH APPLICATOR ( TUBE) in 1 CARTON contains a TUBE, WITH APPLICATOR (64141-003-02)
1 NDC:64141-003-02 4.5 mL in 1 TUBE, WITH APPLICATOR This package is contained within the CARTON (64141-003-01)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 03/01/2009

Labeler - Bobbi Brown Professional Cosmetics Inc (627131279)
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 Pennsylvania Distribution Center 2 828534516 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 manufacture, label, 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
Establishment
Name Address ID/FEI Operations
Aveda Corporation 071352058 manufacture
Establishment
Name Address ID/FEI Operations
NIPPON SHIKIZAI INC 692572936 manufacture, repack, relabel

Revised: 04/2010 Bobbi Brown Professional Cosmetics Inc



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


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