ACTIVE INGREDIENTS: OCTINOXATE 7.50% [] OCTISALATE 5.00%

INACTIVE INGREDIENTS: PETROLATUM [] RICINUS COMMUNIS (CASTOR) SEED OIL [] POLYBUTENE [] MICROCRYSTALLINE WAX\CERA MICROCRISTALLINA\CIRE MICROCRISTALLINE [] ETHYLENE/PROPYLENE/STYRENE COPOLYMER [] HYDROGENATED POLYISOBUTENE [] SILICA [] TOCOPHERYL ACETATE [] SQUALANE [] LECITHIN [] PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL [] BUTYROSPERMUM PARKII (SHEA BUTTER) [] PERSEA GRATISSIMA (AVOCADO) OIL UNSAPONIFIABLES [] LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER WAX [] ASTROCARYUM MURUMURU SEED BUTTER [] POLYDECENE [] CHOLESTEROL [] TRITICUM VULGARE (WHEAT) GERM OIL [] POLYETHYLENE [] BUTYLENE/ETHYLENE/STYRENE COPOLYMER [] TRIETHOXYCAPRYLYLSILANE [] CALCIUM ALUMINUM BOROSILICATE [] TIN OXIDE [] FLAVOR (AROMA) [] SACCHARIN [] LINALOOL [] GERANIOL [] BHT [] TETRAHEXYLDECYL ASCORBATE [] [+/- MICA [] TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] BLUE 1 LAKE (CI 42090) [] RED 6 (CI 15850) [] RED 7 LAKE (CI 15850) [] RED 28 LAKE (CI 45410) [] RED 30 LAKE (CI 73360) [] RED 33 LAKE (CI 17200) [] YELLOW 5 LAKE (CI 19140) [] YELLOW 6 LAKE (CI 15985)

WARNING: STOP USE IF IRRITATION OCCURS.

PRINCIPAL DISPLAY PANEL:

MAC

TINTED LIP CONDITIONER SPF 15

+ LAVENDER

15 ML/0.5 US FL OZ.

DISTR. BY MAKEUP ART COSMETICS
TORONTO, ONTARIO, CANADA, M5V 1R7

TINTED LIP CONDITIONER SPF 15 PLUS LAVENDER
octinoxate, octisalate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:40046-0041
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mL in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)
CASTOR OIL (UNII: D5340Y2I9G)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYISOBUTYLENE (35000 MW) (UNII: 98553S1MHQ)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ALMOND OIL (UNII: 66YXD4DKO9)
SHEA BUTTER (UNII: K49155WL9Y)
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)
CHOLESTEROL (UNII: 97C5T2UQ7J)
WHEAT GERM OIL (UNII: 14C97E680P)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLTRIETHOXYSILANE (UNII: LDC331P08E)
STANNIC OXIDE (UNII: KM7N50LOS6)
SACCHARIN (UNII: FST467XS7D)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
D&C RED NO. 6 (UNII: 481744AI4O)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description
Packaging
1	NDC:40046-0041-1	1 in 1 CARTON
1	NDC:40046-0041-2	15 mL in 1 JAR

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	09/01/2010

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