ACTIVE INGREDIENT: OCTINOXATE 7.5%

INACTIVE INGREDIENTS: WATER [] BUTYLENE GLYCOL [] TRIETHYLHEXANOIN [] SQUALANE [] PROPYLENE GLYCOL STEARATE [] CAPRYLIC/CAPRIC TRIGLYCERIDE [] STEARIC ACID [] GLYCERIN [] KAOLIN [] BETA VULGARIS (BEET) ROOT EXTRACT [] HABERLEA RHODOPENSIS LEAF EXTRACT [] TAMARINDUS INDICA SEED GUM [] YEAST EXTRACT [] MAGNESIUM CHLORIDE [] SODIUM CHLORIDE [] ZINC CHLORIDE [] POTASSIUM CHLORIDE [] LYSINE [] TOCOPHEROL [] PANTHENOL [] POLYSORBATE 20 [] LECITHIN [] TROMETHAMINE [] XANTHAN GUM [] ASCORBYL PALMITATE [] RETINYL PALMITATE [] CAPRYLYL GLYCOL [] SIMETHICONE [] CETYL ALCOHOL [] HYDROGENATED LECITHIN [] MAGNESIUM ALUMINUM SILICATE [] ISOSTEARIC ACID [] HEXYLENE GLYCOL [] PENTYLENE GLYCOL [] DISODIUM EDTA [] POTASSIUM SORBATE [] PHENOXYETHANOL [] [+/- MICA [] TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] CHROMIUM OXIDE GREENS (CI 77288)]

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

PRINCIPAL DISPLAY PANEL:

MAC

SATINFINISH SPF 15

FOUNDATION

30 ML/1 FL OZ

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

MINERALIZE SATIN FOUNDATION SPF 15 FOUNDATION
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:40046-0042
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)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SQUALANE (UNII: GW89575KF9)
ISOSTEARIC ACID (UNII: X33R8U0062)
GLYCERIN (UNII: PDC6A3C0OX)
KAOLIN (UNII: 24H4NWX5CO)
STEARIC ACID (UNII: 4ELV7Z65AP)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
BEET (UNII: N487KM8COK)
YEAST (UNII: 3NY3SM6B8U)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ZINC CHLORIDE (UNII: 86Q357L16B)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
LYSINE (UNII: K3Z4F929H6)
ALPHA-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
PANTHENOL (UNII: WV9CM0O67Z)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TROMETHAMINE (UNII: 023C2WHX2V)
XANTHAN GUM (UNII: TTV12P4NEE)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
2-OCTANOL (UNII: 66B0DD5E40)
CETYL ALCOHOL (UNII: 936JST6JCN)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description
Packaging
1	NDC:40046-0042-1	1 in 1 CARTON
1	NDC:40046-0042-2	30 mL in 1 BOTTLE, GLASS

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	09/01/2006

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

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