STUDIO MOISTURE FIX SPF 15- zinc oxide, octinoxate lotion 
MAKE UP ART COSMETICS

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENTS: ZINC OXIDE 6.70% [] OCTINOXATE 3.50%

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


DIRECTIONS: SMOOTH OVER CLEAN FACE AND THROAT

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


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

FOLDING CARTON





STUDIO MOISTURE FIX  SPF 15
zinc oxide, octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40046-0046
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.7 mL  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:40046-0046-11 in 1 CARTON
1NDC:40046-0046-250 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/01/2006
Labeler - MAKE UP ART COSMETICS (010597206)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD205952385manufacture
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326manufacture
Establishment
NameAddressID/FEIBusiness Operations
Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aramis Inc.042918826manufacture
Establishment
NameAddressID/FEIBusiness Operations
Northtec Bristol949264774manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Northtec Keystone618107429manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd.255175580manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd253616536manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Distribution Center208579636repack, relabel
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Kabushiki Kaisha712808195relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Whitman Laboratories Ltd.216866277manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058manufacture

Revised: 7/2011
Document Id: 39b10a01-cdd9-4b41-857e-3f8ea313843a
Set id: fada26d2-f858-4916-8ebd-d28078a5b3cd
Version: 1
Effective Time: 20110715
 
MAKE UP ART COSMETICS