STUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10- titanium dioxide liquid

STUDIO SKIN by

Drug Labeling and Warnings

STUDIO SKIN by is a Otc medication manufactured, distributed, or labeled by SMASHBOX BEAUTY 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 INGREDIENT: TITANIUM DIOXIDE, 4.7%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: WATER [] CYCLOPENTASILOXANE [] TRIMETHYLSILOXYSILICATE [] BUTYLENE GLYCOL [] TRIMETHYL PENTAPHENYL TRISILOXANE [] SILICA [] PHENYL TRIMETHICONE [] MAGNESIUM SULFATE [] POLYGLYCERYL-3 DIISOSTEARATE [] TRIBEHENIN [] PEG-10 DIMETHICONE [] BIS-PEG/PPG-14/14 DIMETHICONE [] TOCOPHERYL ACETATE [] SODIUM HYALURONATE [] GLYCERIN [] ETHYLHEXYLGLYCERIN [] POLYGLYCERYL-4 ISOSTEARATE [] CETYL PEG/PPG-10/1 DIMETHICONE [] METHICONE [] TETRAMETHYL HEXAPHENYL TETRASILOXANE [] PHENYL METHICONE [] DIMETHICONE [] LAURETH-7 [] POLYMETHYLSILSESQUIOXANE [] HEXYL LAURATE [] DISTEARDIMONIUM HECTORITE [] CELLULOSE GUM [] PROPYLENE CARBONATE [] ALUMINA [] XANTHAN GUM [] DIMETHICONE SILYLATE [] SORBIC ACID [] PHENOXYETHANOL [] CHLORPHENESIN []  [+/- IRON OXIDES (CI 77491, CI 77492, CI 77499) [] TITANIUM DIOXIDE (CI 77891)]

WHEN USING

DIRECTIONS: APPLY BEFORE SUN EXPOSURE.

WARNINGS

WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. IF IRRITATION PERSISTS, CONSULT A HEALTH PRACTITIONER. KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

SMASHBOX

STUDIO SKIN

15 HOUR WEAR FOUNDATION

SPF 10

NET WT. 1 FL OZ/30 ML

Smashbox Beauty Cosmetics Inc,

Culver City, CA 90232

INGREDIENTS AND APPEARANCE

STUDIO SKIN  15 HOUR WEAR FOUNDATION SPF10
titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10348-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.7 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DIMETHICONE (UNII: 92RU3N3Y1O)
LAURETH-7 (UNII: Z95S6G8201)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ALUMINUM OXIDE (UNII: LMI26O6933)
XANTHAN GUM (UNII: TTV12P4NEE)
SORBIC ACID (UNII: X045WJ989B)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10348-001-01	1 in 1 CARTON
1	NDC: 10348-001-02	30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2009

Labeler - SMASHBOX BEAUTY COSMETICS, INC (945344414)

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