PREP and PRIME FACE PROTECTION SPF 50

Dosage form: cream
Ingredients: ZINC OXIDE 16.1mL in 100mL, OCTINOXATE 7.5mL in 100mL
Labeler: MAKEUP ART COSMETICS
NDC Code: 40046-0047

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: ZINC OXIDE 16.10% [] OCTINOXATE 7.50%

INACTIVE INGREDIENTS: WATER\AQUA\EAU [] CYCLOPENTASILOXANE [] BUTYLENE GLYCOL [] PEG-7 DIMETHICONE [] CYCLOHEXASILOXANE [] DIMETHICONE [] PHENYL TRIMETHICONE [] VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER [] METHYL GLUCETH-10 [] GLYCERIN [] DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER [] CAFFEINE [] TOCOPHEROL [] SUCROSE [] STEARYL GLYCYRRHETINATE [] CELLULOSE ACETATE [] METHICONE [] PEG/PPG-19/19 DIMETHICONE [] MAGNESIUM SULFATE [] SILICA DIMETHYL SILYLATE [] SILICA [] SORBIC ACID [] PHENOXYETHANOL [] CHLORPHENESIN

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

PRINCIPAL DISPLAY PANEL



MAC

PREP + PRIME

FACE PROTECT

PROTECTION

SPF 50



1 FL OZ/ 30 ML



makeup art cosmetics

toronto, canada




PREP AND PRIME FACE PROTECTION  SPF 50
zinc oxide, octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40046-0047
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE16.1 mL  in 100 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 5 
BUTYLENE GLYCOL 
DIMETHICONE 
CYCLOMETHICONE 6 
PHENYL TRIMETHICONE 
METHYL GLUCETH-10 
GLYCERIN 
CAFFEINE 
ALPHA-TOCOPHEROL 
SUCROSE 
STEARYL GLYCYRRHETINATE 
CELLULOSE ACETATE 
MAGNESIUM SULFATE, UNSPECIFIED 
SILICON DIOXIDE 
SORBIC ACID 
PHENOXYETHANOL 
CHLORPHENESIN 
Packaging
#Item CodePackage Description
1NDC:40046-0047-11 TUBE (TUBE) in 1 CARTON
1NDC:40046-0047-230 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/2006
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
Establishment
NameAddressID/FEIOperations
NIPPON SHIKIZAI INC692572936manufacture

Revised: 09/2011
 
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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