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Name:Bobbi Brown Brightening Protective Face Baseuv Spf 50
Manufacturer:Bobbi Brown Professional Cosmetics Inc.
Category:Over-the-counter (OTC) Marketed Drugs


BOBBI BROWN BRIGHTENING PROTECTIVE FACE BASE UV SPF 50 - homosalate, octisalate, avobenzone and oxybenzone 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: HOMOSALATE 5.00% [] OCTISALATE 5.00% [] AVOBENZONE 3.00% [] OXYBENZONE 3.00%

DIRECTIONS: SMOOTH ON SKIN BEFORE OR AFTER MAKEUP

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

BOBBI BROWN

BRIGHTENING

SPF 50 UV

PROTECTIVE FACE BASE

1.7 OZ/50 ML

DIST. BOBBI BROWN PROFESSIONAL COSMETICS

NEW YORK, NY 10022

FOLDING CARTON



BOBBI BROWN BRIGHTENING PROTECTIVE FACE BASE  UV SPF 50
homosalate, octisalate, avobenzone, oxybenzone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:64141-005
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE (HOMOSALATE) HOMOSALATE 5.0 mL  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE 5.0 mL  in 100 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE 3.0 mL  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 3.0 mL  in 100 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64141-005-01 1 TUBE ( TUBE) in 1 CARTON contains a TUBE (64141-005-02)
1 NDC:64141-005-02 50 mL in 1 TUBE This package is contained within the CARTON (64141-005-01)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 07/13/2010

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 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: 07/2010 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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