PREP AND PRIME FACE PROTECTION SPF 50- zinc oxide, octinoxate cream

PREP and PRIME FACE PROTECTION by

Drug Labeling and Warnings

PREP and PRIME FACE PROTECTION by is a Otc medication manufactured, distributed, or labeled by MAKEUP 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, NIPPON SHIKIZAI INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS: ZINC OXIDE 16.10% [] OCTINOXATE 7.50%

INACTIVE INGREDIENT

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

WARNINGS

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

MAC

PREP + PRIME

FACE PROTECT

PROTECTION

SPF 50

1 FL OZ/ 30 ML

makeup art cosmetics

toronto, canada

INGREDIENTS AND APPEARANCE

PREP AND PRIME FACE PROTECTION  SPF 50
zinc oxide, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 40046-0047
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	16.1 mL  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
METHYL GLUCETH-10 (UNII: N0MWT4C7WH)
GLYCERIN (UNII: PDC6A3C0OX)
CAFFEINE (UNII: 3G6A5W338E)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
SUCROSE (UNII: C151H8M554)
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
CELLULOSE ACETATE (UNII: 3J2P07GVB6)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBIC ACID (UNII: X045WJ989B)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 40046-0047-1	1 in 1 CARTON
1	NDC: 40046-0047-2	30 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2006

Labeler - MAKEUP 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

Establishment
Name	Address	ID/FEI	Business Operations
NIPPON SHIKIZAI INC		692572936	manufacture