ACTIVE INGREDIENT: OCTINOXATE 7.50%

INACTIVE INGREDIENTS: WATER [] DIMETHICONE [] PHENYL TRIMETHICONE [] TALC [] BUTYLENE GLYCOL [] POLYMETHYL METHACRYLATE [] POLYDECENE [] GLYCERYL DILAURATE [] CAPRYLYL GLYCOL [] TEA-ISOSTEARATE [] TEA-STEARATE [] KAOLIN [] TOCOPHERYL ACETATE [] ASCORBYL PALMITATE [] RETINYL PALMITATE [] HYDROGENATED LECITHIN [] PANTETHINE [] XANTHAN GUM [] CELLULOSE GUM [] TETRADIBUTYL PENTAERITHRITYL HYDROXYHYDROCINNAMATE [] HEXYLENE GLYCOL [] STEARETH-21 [] MAGNESIUM ALUMINUM SILICATE [] STEARETH-2 [] POLYPERFLUOROMETHYLISOPROPYL ETHER [] STEARYL ALCOHOL [] DISODIUM EDTA [] PHENOXYETHANOL [] [+/- TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] CHROMIUM OXIDE GREENS (CI 77288)]

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

MAC

SELECT

SPF 15

FOUNDATION

1.0 FL/OZ/ 30 ML

DISTR. MAKEUP ART COSMETICS
ONTARIO, CANADA

SELECT SPF 15 FOUNDATION
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:40046-0052
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)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TALC (UNII: 7SEV7J4R1U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TROLAMINE (UNII: 9O3K93S3TK)
STEARIC ACID (UNII: 4ELV7Z65AP)
KAOLIN (UNII: 24H4NWX5CO)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
PANTETHINE (UNII: 7K81IL792L)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
STEARETH-21 (UNII: 53J3F32P58)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CHROMIC OXIDE (UNII: X5Z09SU859)

#	Item Code	Package Description
Packaging
1	NDC:40046-0052-1	1 in 1 CARTON
1	NDC:40046-0052-2	30 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	12/01/2001

Labeler - MAKEUP ART COSMETICS (010597206)

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

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

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

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

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

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

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

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

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

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

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

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

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