ACTIVE INGREDIENT

OCTINOXATE 7.50%

INGREDIENTS

WATER\AQUA\EAU, DIMETHICONE, SILICA, CETYL DIMETHICONE, PHENYL TRIMETHICONE, BUTYLENE GLYCOL, POLYDECENE, GLYCERYL DILAURATE, ISOSTEARIC ACID, TROMETHAMINE, TOCOPHERYL ACETATE, SODIUM HYALURONATE, SUCROSE, HYDROGENATED LECITHIN, CAFFEINE, LINOLEIC ACID, XANTHAN GUM, CELLULOSE GUM, CHOLESTEROL, POLYETHYLENE, MAGNESIUM ALUMINUM SILICATE, PEG-9 DIMETHICONE, ETHYLHEXYLGLYCERIN, CAPRYLYL GLYCOL, HEXYLENE GLYCOL, TETRADIBUTYL PENTAERITHRITYL HYDROXYHYDROCINNAMATE, STEARETH-21, STEARETH-2, STEARIC ACID, POLYPERFLUOROMETHYLISOPROPYL ETHER, TETRASODIUM EDTA, BENZOIC ACID, DEHYDROACETIC ACID, PHENOXYETHANOL [+/- MICA, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499), CHROMIUM OXIDE GREENS (CI 77288)] <ILN32363>

WARNING

KEEP OUT OF EYES.

STOP USE IF IRRITATION OCCURS.

KEEP OUT OF REACH OF CHILDREN.

DIST. BY/PAR: MAKE-UP ART COSMETICS
TORONTO, ONTARIO, CANADA M5V 1R7,
LONDON W1K 3BQ. / M3H2

PRINCIPAL DISPLAY PANEL - 50 ML Bottle Carton

M•A•C

SELECT TINT SPF 15

50 ML/1.7 US FL OZ e

PRINCIPAL DISPLAY PANEL - 50 ML Bottle Carton

MAC SELECT TINT SPF 15
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:40046-0055
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERYL DILAURATE (UNII: MFL3ZIE8SK)
ISOSTEARIC ACID (UNII: X33R8U0062)
TROMETHAMINE (UNII: 023C2WHX2V)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SUCROSE (UNII: C151H8M554)
CAFFEINE (UNII: 3G6A5W338E)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CHOLESTEROL (UNII: 97C5T2UQ7J)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
STEARETH-21 (UNII: 53J3F32P58)
STEARETH-2 (UNII: V56DFE46J5)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE SODIUM (UNII: MP1J8420LU)
BENZOIC ACID (UNII: 8SKN0B0MIM)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CHROMIC OXIDE (UNII: X5Z09SU859)

#	Item Code	Package Description
Packaging
1	NDC:40046-0055-1	1 in 1 CARTON
1		50 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	08/01/2002

Labeler - MAKEUP ART COSMETICS (010597206)

Name	Address	ID/FEI	Business Operations
Establishment
ELGC K.K.		712808195	RELABEL(40046-0055) , REPACK(40046-0055)

Name	Address	ID/FEI	Business Operations
Establishment
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE(40046-0055) , RELABEL(40046-0055) , REPACK(40046-0055)

Name	Address	ID/FEI	Business Operations
Establishment
Estee Lauder Inc.		042918826	MANUFACTURE(40046-0055)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	RELABEL(40046-0055) , REPACK(40046-0055)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COSMETICS, LTD		253616536	MANUFACTURE(40046-0055)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(40046-0055)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE(40046-0055)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER N.V.		370151326	MANUFACTURE(40046-0055)

Name	Address	ID/FEI	Business Operations
Establishment
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(40046-0055)

Name	Address	ID/FEI	Business Operations
Establishment
NORTEC KEYSTONE		943871157	MANUFACTURE(40046-0055) , RELABEL(40046-0055) , REPACK(40046-0055)

Name	Address	ID/FEI	Business Operations
Establishment
NORTHTEC BRISTOL		959338336	MANUFACTURE(40046-0055) , RELABEL(40046-0055) , REPACK(40046-0055)

Name	Address	ID/FEI	Business Operations
Establishment
NORTHTEC KEYSTONE		949264774	MANUFACTURE(40046-0055) , RELABEL(40046-0055) , REPACK(40046-0055)

Name	Address	ID/FEI	Business Operations
Establishment
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(40046-0055)

Name	Address	ID/FEI	Business Operations
Establishment
Aveda Corporation		071352058	MANUFACTURE(40046-0055)

Name	Address	ID/FEI	Business Operations
Establishment
Pennsylvania Logistics Center		078364654	REPACK(40046-0055) , RELABEL(40046-0055)