MINERALIZE SATIN FOUNDATION SPF 15 FOUNDATION- octinoxate liquid

MINERALIZE by

Drug Labeling and Warnings

MINERALIZE by is a Otc medication manufactured, distributed, or labeled by MAKEUP 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, MANA COSMETICS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT: OCTINOXATE 7.5%

INACTIVE INGREDIENT

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)]

WARNINGS

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL:

MAC

SATINFINISH SPF 15

FOUNDATION

30 ML/1 FL OZ

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

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - MAKEUP 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

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