PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35- octinoxate, octisalate, zinc oxide, oxybenzone cream 
MAKEUP 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: OCTINOXATE 7.40% [] OCTISALATE 4.00% [] ZINC OXIDE 3.50% [] OXYBENZONE 2.50% [] TITANIUM DIOXIDE 1.10%

INACTIVE INGREDIENTS: WATER\AQUA\EAU [] DIMETHICONE [] BUTYLENE GLYCOL [] PHENYL TRIMETHICONE [] PENTYLENE GLYCOL [] GLYCERYL STEARATE [] BEHENYL ALCOHOL [] TRIOCTYLDODECYL CITRATE [] POLYMETHYLSILSESQUIOXANE [] OCTYLDODECYL STEAROYL STEARATE [] PEG-40 STEARATE [] POLYGLYCERYL-10 PENTASTEARATE [] OCTYLDODECYL NEOPENTANOATE [] TOCOPHERYL ACETATE [] CAFFEINE [] GLYCYRRHETINIC ACID [] UREA [] SODIUM HYALURONATE [] SQUALANE [] HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE [] TRITICUM VULGARE (WHEAT) GERM EXTRACT [] LAMINARIA SACCHARINA EXTRACT [] GLYCERIN [] LECITHIN [] POLYGLYCERYL-6 POLYRICINOLEATE [] CHOLESTEROL [] TREHALOSE [] SODIUM PCA [] ORYZANOL [] AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER [] SUCROSE [] SODIUM STEAROYL LACTYLATE [] XANTHAN GUM [] POLYQUATERNIUM-51 [] ISOPROPYL TITANIUM TRIISOSTEARATE [] TRIETHOXYCAPRYLYLSILANE [] SILICA [] ALUMINA [] LINOLEIC ACID [] STEARIC ACID [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] DISODIUM EDTA [] PHENOXYETHANOL [] CHLORPHENESIN [] SODIUM DEHYDROACETATE []  [+/- MICA [] TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] BISMUTH OXYCHLORIDE (CI 77163) [] BLUE 1 LAKE (CI 42090) [] CARMINE (CI 75470) [] CHROMIUM HYDROXIDE GREEN (CI 77289) [] FERRIC FERROCYANIDE (CI 77510) [] YELLOW 5 LAKE (CI 19140)]

DIRECTIONS: SMOOTH EVENLY ALL OVER THE FACE OR TO THE DESIRED AREAS AFTER MOISTURIZER WITH FINGERTIPS, SPONGE OR BRUSH.

WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. IF IRRITATION PERSISTS, DISCONTINUE USE AND CONTACT A HEALTH CARE PRACTITIONER.

KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL:

MAC

PREP + PRIME

FORTIFIED SKIN ENHANCER

SPF 35


NT WT 1.0 FL OZ/ 30 ML



DISTR BY MAKE UP ART COSMETICS

TORONTO, ONTARIO, CANADA M5V 1R7

FOLDING CARTON




PREP AND PRIME  FORTIFIED SKIN ENHANCER SPF 35
octinoxate, octisalate, zinc oxide, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40046-0039
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.4 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.0 mL  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.5 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2.5 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
DOCOSANOL (UNII: 9G1OE216XY)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CAFFEINE (UNII: 3G6A5W338E)  
ENOXOLONE (UNII: P540XA09DR)  
UREA (UNII: 8W8T17847W)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SQUALANE (UNII: GW89575KF9)  
BARLEY (UNII: 5PWM7YLI7R)  
WHEAT GERM (UNII: YR3G369F5A)  
GLYCERIN (UNII: PDC6A3C0OX)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
TREHALOSE (UNII: B8WCK70T7I)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
GAMMA ORYZANOL (UNII: SST9XCL51M)  
SUCROSE (UNII: C151H8M554)  
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
LINOLEIC ACID (UNII: 9KJL21T0QJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:40046-0039-11 in 1 CARTON
1NDC:40046-0039-230 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/01/2011
Labeler - MAKEUP 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: 8e82c4a4-fbc9-46bb-980e-31e302be7f7a
Set id: a1b22e6f-5dde-48b0-86f2-305b1bc67c0c
Version: 1
Effective Time: 20110714
 
MAKEUP ART COSMETICS