SKIN FOUNDATION MINERAL MAKEUP SPF 15- titanium dioxide, octinoxate powder 
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: TITANIUM DIOXIDE 7.80% [] OCTINOXATE 3.60%

INACTIVE INGREDIENTS: VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER [] HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER [] POLYSILICONE-11 [] SILICA [] POLYMETHYLSILSESQUIOXANE [] PHENYL TRIMETHICONE [] GLYCINE SOJA (SOYBEAN) SEED EXTRACT [] PANTHENOL [] CERAMIDE 2 [] CERAMIDE 3 [] GLYCERIN [] ERGOTHIONEINE [] SODIUM HYALURONATE [] C9-15 FLUOROALCOHOL PHOSPHATE [] TRIMETHYLSILOXYSILICATE [] TOCOPHERYL ACETATE [] ASCORBYL PALMITATE [] CAPRYLYL GLYCOL [] ASCORBYL TOCOPHERYL MALEATE [] MAGNESIUM STEARATE [] NYLON-12 [] LAURETH-12 [] ALUMINA [] AMINOPROPYL ASCORBYL PHOSPHATE [] ALUMINUM HYDROXIDE []  [+/- MICA [] TITANIUM DIOXIDE (CI 77891) [] ZINC OXIDE (CI 77947) [] IRON OXIDES (CI 77491, CI 77492, CI 77499)

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



BOBBI BROWN

SKIN FOUNDATION

MINERAL MAKEUP
SPF 15



0.2 OZ / 6 g


DISTR BOBBI BROWN PROFESSIONAL COSMETICS

NEW YORK, NY 10022

FOLDING CARTON

SKIN FOUNDATION MINERAL MAKEUP  SPF 15
titanium dioxide, octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64141-111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7.8 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYSILICONE-15 (UNII: F8DRP5BB29)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SOYBEAN (UNII: L7HT8F1ZOD)  
PANTHENOL (UNII: WV9CM0O67Z)  
CERAMIDE 2 (UNII: C04977SRJ5)  
CERAMIDE 3 (UNII: 4370DF050B)  
GLYCERIN (UNII: PDC6A3C0OX)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
TRIMETHYLSILANE (UNII: 9L70DJH2K0)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
LAURETH-12 (UNII: OAH19558U1)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
MICA (UNII: V8A1AW0880)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64141-111-011 in 1 CARTON
1NDC:64141-111-026 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/2011
Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD205952385manufacture
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326manufacture
Establishment
NameAddressID/FEIBusiness Operations
Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aramis Inc.042918826manufacture
Establishment
NameAddressID/FEIBusiness Operations
Northtec Bristol949264774manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Northtec Keystone618107429manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd.255175580manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd253616536manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Distribution Center208579636repack, relabel
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Kabushiki Kaisha712808195relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Whitman Laboratories Ltd.216866277manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058manufacture

Revised: 9/2011
Document Id: 3bf0b661-620d-4115-89cd-eb55fe852e2a
Set id: a033ad5f-8b3d-4b75-a59d-516a92099ba4
Version: 1
Effective Time: 20110919
 
Bobbi Brown Professional Cosmetics Inc.