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Name:Bobbi Brown Extraspf 25 Moisturizing Balm
Manufacturer:Bobbi Brown Professional Cosmetics Inc
Category:Over-the-counter (OTC) Marketed Drugs


BOBBI BROWN EXTRA SPF 25 MOISTURIZING BALM - homosalate, octinoxate, oxybenzone and avobenzone 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 10.00% [] OCTINOXATE 7.50% [] OXYBENZONE 5.00% [] AVOBENZONE 2.00%

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

DIRECTIONS: WARM IN HANDS AND APPLY TO CLEAN SKIN

PRINCIPAL DISPLAY PANEL:


BOBBI BROWN

EXTRA

SPF 25 MOISTURIZING BALM

POIDS NET. 1.7 OZ / 50 ML


BOBBI BROWN PROFESSIONAL COSMETICS
NEW YORK, NY 10022
E109

WWW.BOBBIBROWN.COM
FOLDING CARTON

 




BOBBI BROWN EXTRA  SPF 25 MOISTURIZING BALM
homosalate, octinoxate, oxybenzone, avobenzone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:64141-916
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE (HOMOSALATE) HOMOSALATE 10 mL  in 100 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 mL  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 5.0 mL  in 100 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE 2.0 mL  in 100 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64141-916-01 1 JAR ( JAR) in 1 CARTON contains a JAR (64141-916-02)
1 NDC:64141-916-02 50 mL in 1 JAR This package is contained within the CARTON (64141-916-01)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 10/01/2000

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

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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