STUDIO MOISTURE TINT SPF 15- octinoxate gel

STUDIO MOISTURE TINT by

Drug Labeling and Warnings

STUDIO MOISTURE TINT 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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT: OCTINOXATE, 3.5%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: WATER [] CYCLOPENTASILOXANE [] BUTYLENE GLYCOL [] STEARETH-21 [] GLYCERYL STEARATE [] DIMETHICONE [] ISOSTEARIC ACID [] TROMETHAMINE [] TOCOPHERYL ACETATE [] LECITHIN [] CHOLESTEROL [] ASCORBYL PALMITATE [] SODIUM HYALURONATE [] CAFFEINE [] ALOE BARBADENSIS LEAF WATER [] HYDROGENATED LECITHIN [] SUCROSE [] SORBITOL [] SILICA [] TREHALOSE [] MAGNESIUM ALUMINUM SILICATE [] CARBOMER [] STEARETH-2 [] CELLULOSE GUM [] PVP [] PALMITOYL OLIGOPEPTIDE [] GLYCERYL POLYMETHACRYLATE [] METHYLDIHYDROJASMONATE [] XANTHAN GUM [] CAPRYLYL GLYCOL [] STEARIC ACID [] SODIUM CITRATE [] PEG-8 [] GLYCERIN [] DISODIUM EDTA [] HEXYLENE GLYCOL [] BHT [] PHENOXYETHANOL [] CHLORPHENESIN [] CHLOROXYLENOL []  [+/- MICA [] TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499)

WHEN USING

DIRECTIONS: AFTER CLEANSING, APPLY TO CLEAN SKIN WITH FINGERTIPS, SPONGE OR BRUSH

WARNINGS

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL:

MAC

STUDIO MOISTURE TINT

SPF 15



40 ML/1.3 US FL OZ




DISTR MAKE UP ART COSMETICS
TORONTO, ONTARIO, CANADA, M5V 1R7

INGREDIENTS AND APPEARANCE

STUDIO MOISTURE TINT  SPF 15
octinoxate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 40046-0033
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
STEARETH-21 (UNII: 53J3F32P58)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOSTEARIC ACID (UNII: X33R8U0062)
TROMETHAMINE (UNII: 023C2WHX2V)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CHOLESTEROL (UNII: 97C5T2UQ7J)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CAFFEINE (UNII: 3G6A5W338E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
SUCROSE (UNII: C151H8M554)
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TREHALOSE (UNII: B8WCK70T7I)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
STEARETH-2 (UNII: V56DFE46J5)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)
XANTHAN GUM (UNII: TTV12P4NEE)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 40046-0033-1	1 in 1 CARTON
1	NDC: 40046-0033-2	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	01/01/2009

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