STUDIO SCULPT SPF 15 FOUNDATION- octinoxate, titanium dioxide liquid

STUDIO SCULPT by

Drug Labeling and Warnings

STUDIO SCULPT by is a Otc medication manufactured, distributed, or labeled by MAKE UP ART COSMETICS, 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, MANA COSMETICS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS: OCTINOXATE 7.00% [] TITANIUM DIOXIDE 2.00%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: WATER [] CYCLOPENTASILOXANE [] GLYCERIN [] BUTYLENE GLYCOL [] OCTYLDODECYL NEOPENTANOATE [] PEG/PPG-18/18 DIMETHICONE [] POLYMETHYLSILSESQUIOXANE [] ISOSTEARIC ACID [] C4-24 ALKYL DIMETHICONE/DIVINYLDIMETHICONE CROSSPOLYMER [] ISONONYL ISONONANOATE [] TAMARINDUS INDICA SEED EXTRACT [] TOCOPHEROL [] TOCOPHERYL ACETATE [] SODIUM HYALURONATE [] HABERLEA RHODOPENSIS LEAF EXTRACT [] BUTYROSPERMUM PARKII (SHEA BUTTER) [] YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE [] QUERCUS SUBER BARK EXTRACT [] PHYTANTRIOL [] DEXTRIN PALMITATE [] DEXTRIN PALMITATE/ETHYLHEXANOATE [] CELLULOSE GUM [] TETRAHEXYLDECYL ASCORBATE [] XANTHAN GUM [] DIMETHICONE [] METHICONE [] PROPYLENE CARBONATE [] SODIUM CHLORIDE [] PALMITIC ACID [] POLYGLYCERYL-4 ISOSTEARATE [] CETYL PEG/PPG-10/1 DIMETHICONE [] HEXYL LAURATE [] POLYMETHYL METHACRYLATE [] OCTYLDODECYL PCA [] DISTEARDIMONIUM HECTORITE [] STEARIC ACID [] CAPRYLYL GLYCOL [] DIPROPYLENE GLYCOL [] PHENOXYETHANOL [] ALUMINUM STEARATE [] HEXYLENE GLYCOL []  [+/- MICA [] TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] CHROMIUM OXIDE GREENS (CI 77288)]

WARNINGS

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

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL:

MAC

STUDIO SCULPT

SPF 15 FOUNDATION

40 ML/ 1.3 US FL OZ

DISTR BY MAKE-UP ART COSMETICS

TORONTO, ONTARIO

CANADA

INGREDIENTS AND APPEARANCE

STUDIO SCULPT  SPF 15 FOUNDATION
octinoxate, titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 40046-0032
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.0 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.0 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISOSTEARIC ACID (UNII: X33R8U0062)
TAMARINDUS INDICA SEED (UNII: 6AHP8A7OML)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ALPHA-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 40046-0032-1	1 in 1 CARTON
1	NDC: 40046-0032-2	40 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2008

Labeler - MAKE UP ART COSMETICS (010597206)

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

Establishment
Name	Address	ID/FEI	Business Operations
MANA COSMETICS INC		078870292	manufacture