PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35

Dosage form: cream
Ingredients: OCTINOXATE 7.4mL in 100mL, OCTISALATE 4.0mL in 100mL, ZINC OXIDE 3.5mL in 100mL, OXYBENZONE 2.5mL in 100mL, TITANIUM DIOXIDE 1.1mL in 100mL
Labeler: MAKEUP ART COSMETICS
NDC Code: 40046-0039

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.

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




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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.4 mL  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE4.0 mL  in 100 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE3.5 mL  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE2.5 mL  in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE1.1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
DIMETHICONE 
BUTYLENE GLYCOL 
PHENYL TRIMETHICONE 
PENTYLENE GLYCOL 
GLYCERYL MONOSTEARATE 
DOCOSANOL 
POLYMETHYLSILSESQUIOXANE (11 MICRONS) 
OCTYLDODECYL STEAROYL STEARATE 
PEG-40 STEARATE 
OCTYLDODECYL NEOPENTANOATE 
ALPHA-TOCOPHEROL ACETATE 
CAFFEINE 
ENOXOLONE 
UREA 
HYALURONATE SODIUM 
SQUALANE 
BARLEY 
WHEAT GERM 
GLYCERIN 
LECITHIN, SOYBEAN 
CHOLESTEROL 
TREHALOSE 
SODIUM PYRROLIDONE CARBOXYLATE 
GAMMA ORYZANOL 
SUCROSE 
SODIUM STEAROYL LACTYLATE 
XANTHAN GUM 
TRIETHOXYCAPRYLYLSILANE 
SILICON DIOXIDE 
ALUMINUM OXIDE 
LINOLEIC ACID 
STEARIC ACID 
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) 
EDETATE DISODIUM 
PHENOXYETHANOL 
CHLORPHENESIN 
SODIUM DEHYDROACETATE 
MICA 
FERRIC OXIDE RED 
FD&C YELLOW NO. 5 
Packaging
#Item CodePackage Description
1NDC:40046-0039-11 TUBE (TUBE) 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/FEIOperations
ESTEE LAUDER COSMETICS, LTD205952385manufacture
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER N.V.370151326manufacture
Establishment
NameAddressID/FEIOperations
Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
Establishment
NameAddressID/FEIOperations
Aramis Inc.042918826manufacture
Establishment
NameAddressID/FEIOperations
Northtec Bristol949264774manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Northtec Keystone618107429manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics, Ltd.255175580manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics, Ltd253616536manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics Distribution Center208579636repack, relabel
Establishment
NameAddressID/FEIOperations
Estee Lauder Kabushiki Kaisha712808195relabel, repack
Establishment
NameAddressID/FEIOperations
Whitman Laboratories Ltd.216866277manufacture
Establishment
NameAddressID/FEIOperations
Aveda Corporation071352058manufacture

Revised: 07/2011
 
MAKEUP ART COSMETICS

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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