SKIN FOUNDATION MINERAL MAKEUP SPF 15- titanium dioxide, octinoxate powder

SKIN FOUNDATION MINERAL MAKEUP by

Drug Labeling and Warnings

SKIN FOUNDATION MINERAL MAKEUP by is a Otc medication manufactured, distributed, or labeled by Bobbi Brown Professional Cosmetics Inc., ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER N.V., Len-Ron Manufacturing Division of Aramis Inc., Aramis Inc., Northtec Bristol, Northtec Keystone, Estee Lauder Pennsylvania Distribution Center 2, Estee Lauder Cosmetics, Ltd., Estee Lauder Cosmetics, Ltd, Estee Lauder Cosmetics Distribution Center, Estee Lauder Kabushiki Kaisha, Whitman Laboratories Ltd., Aveda Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS: TITANIUM DIOXIDE 7.80% [] OCTINOXATE 3.60%

INACTIVE INGREDIENT

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)

WARNINGS

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

PRINCIPAL DISPLAY PANEL

BOBBI BROWN

SKIN FOUNDATION

MINERAL MAKEUP
SPF 15

0.2 OZ / 6 g

DISTR BOBBI BROWN PROFESSIONAL COSMETICS

NEW YORK, NY 10022

INGREDIENTS AND APPEARANCE

SKIN FOUNDATION MINERAL MAKEUP  SPF 15
titanium dioxide, octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64141-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	7.8 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64141-111-01	1 in 1 CARTON
1	NDC: 64141-111-02	6 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2011

Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		205952385	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Len-Ron Manufacturing Division of Aramis Inc.		809771152	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Aramis Inc.		042918826	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Northtec Bristol		949264774	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Northtec Keystone		618107429	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2		828534516	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics, Ltd.		255175580	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics, Ltd		253616536	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Distribution Center		208579636	repack, relabel

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Kabushiki Kaisha		712808195	relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Whitman Laboratories Ltd.		216866277	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	manufacture