STUDIO MOISTURE FIX SPF 15- zinc oxide, octinoxate lotion

STUDIO MOISTURE FIX by

Drug Labeling and Warnings

STUDIO MOISTURE FIX 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 INGREDIENTS: ZINC OXIDE 6.70% [] OCTINOXATE 3.50%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: WATER [] DIMETHICONE [] C12-15 ALKYL BENZOATE [] BUTYLENE GLYCOL [] SILICA [] ISONONYL ISONONANOATE [] GLYCERIN [] TOCOPHERYL ACETATE [] CHOLESTEROL [] ASTROCARYUM MURUMURU BUTTER [] CAFFEINE [] SODIUM RNA [] SODIUM HYALURONATE [] PHYTOSPHINGOSINE [] HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE [] PORIA COCOS SCLEROTIUM EXTRACT [] THERMUS THERMOPHILLUS FERMENT [] POLYGONUM CUSPIDATUM ROOT EXTRACT [] SACCHAROMYCES LYSATE EXTRACT [] YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE [] TRITICUM VULGARE (WHEAT) GERM EXTRACT [] SUCROSE [] MAGNESIUM ASCORBYL PHOSPHATE [] POLYSORBATE 20 [] SQUALANE [] POLYSORBATE 80 [] GLYCERYL STEARATE [] PEG-100 STEARATE [] STEARETH-21 [] PVP [] SODIUM CITRATE [] CITRIC ACID [] DISTEARDIMONIUM HECTORITE [] CETYL ESTERS [] HEXYLENE GLYCOL [] POLYETHYLENE [] POLYHYDROXYSTEARIC ACID [] ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER [] AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER [] ISOHEXADECANE [] CAPRYLYL GLYCOL [] TRIETHOXYCAPRYLYLSILANE [] LINOLEIC ACID [] DISODIUM EDTA [] PROPYLENE GLYCOL DICAPRATE [] FRAGRANCE (PARFUM) [] BHT [] PHENOXYETHANOL [] CHLORPHENESIN

WHEN USING

DIRECTIONS: SMOOTH OVER CLEAN FACE AND THROAT

WARNINGS

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

PRINCIPAL DISPLAY PANEL

PRINICIPAL DISPLAY PANEL

MAC

STUDIO

MOISTURE FIX

SPF 15

1.7 US FL OZ/ 50 ML

DISTR MAKE-UP ART COSMETICS

TORONTO, ONTARIO, CANADA, M5V1R7

INGREDIENTS AND APPEARANCE

STUDIO MOISTURE FIX  SPF 15
zinc oxide, octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 40046-0046
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.7 mL  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
GLYCERIN (UNII: PDC6A3C0OX)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHOLESTEROL (UNII: 97C5T2UQ7J)
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)
CAFFEINE (UNII: 3G6A5W338E)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BARLEY (UNII: 5PWM7YLI7R)
FU LING (UNII: XH37TWY5O4)
POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7)
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)
YEAST (UNII: 3NY3SM6B8U)
WHEAT GERM (UNII: YR3G369F5A)
SUCROSE (UNII: C151H8M554)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SQUALANE (UNII: GW89575KF9)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
STEARETH-21 (UNII: 53J3F32P58)
POVIDONE K17 (UNII: C67P1734QJ)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CETYL ESTERS WAX (UNII: D072FFP9GU)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ISOHEXADECANE (UNII: 918X1OUF1E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 40046-0046-1	1 in 1 CARTON
1	NDC: 40046-0046-2	50 mL in 1 BOTTLE

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

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