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

folding carton

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - MAKEUP ART COSMETICS (010597206)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COSMETICS, LTD		205952385	manufacture

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER N.V.		370151326	manufacture

Name	Address	ID/FEI	Business Operations
Establishment
Len-Ron Manufacturing Division of Aramis Inc.		809771152	manufacture

Name	Address	ID/FEI	Business Operations
Establishment
Aramis Inc.		042918826	manufacture

Name	Address	ID/FEI	Business Operations
Establishment
Northtec Bristol		949264774	manufacture, relabel, repack

Name	Address	ID/FEI	Business Operations
Establishment
Northtec Keystone		618107429	manufacture, relabel, repack

Name	Address	ID/FEI	Business Operations
Establishment
Estee Lauder Pennsylvania Distribution Center 2		828534516	manufacture, relabel, repack

Name	Address	ID/FEI	Business Operations
Establishment
Estee Lauder Cosmetics, Ltd.		255175580	manufacture

Name	Address	ID/FEI	Business Operations
Establishment
Estee Lauder Cosmetics, Ltd		253616536	manufacture

Name	Address	ID/FEI	Business Operations
Establishment
Estee Lauder Cosmetics Distribution Center		208579636	repack, relabel

Name	Address	ID/FEI	Business Operations
Establishment
Estee Lauder Kabushiki Kaisha		712808195	relabel, repack

Name	Address	ID/FEI	Business Operations
Establishment
Whitman Laboratories Ltd.		216866277	manufacture

Name	Address	ID/FEI	Business Operations
Establishment
Aveda Corporation		071352058	manufacture

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