TINTED LIP CONDITIONER SPF 15- octinoxate, octisalate gel

TINTED LIP CONDITIONER by

Drug Labeling and Warnings

TINTED LIP CONDITIONER 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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS: OCTINOXATE 7.50% [] OCTISALATE 5.00%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: PETROLATUM [] RICINUS COMMUNIS (CASTOR) SEED OIL [] POLYBUTENE [] MICROCRYSTALLINE WAX \CERA MICROCRISTALLINA\CIRE MICROCRISTALLINE [] ETHYLENE/PROPYLENE/STYRENE COPOLYMER [] HYDROGENATED POLYISOBUTENE [] FRAGRANCE (PARFUM) [] SILICA [] BUTYROSPERMUM PARKII (SHEA BUTTER) [] PERSEA GRATISSIMA (AVOCADO) OIL UNSAPONIFIABLES [] TRITICUM VULGARE (WHEAT) GERM OIL [] CHAMOMILLA RECUTITA (MATRICARIA) FLOWER OIL [] ASTROCARYUM MURUMURU BUTTER [] PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL [] TOCOPHERYL ACETATE [] RETINYL PALMITATE [] CHOLESTEROL [] LECITHIN [] SQUALANE [] POLYETHYLENE [] POLYDECENE [] BUTYLENE/ETHYLENE/STYRENE COPOLYMER [] TRIETHOXYCAPRYLYLSILANE [] TETRAHEXYLDECYL ASCORBATE [] SACCHARIN [] VANILLIN [] BHT []  [+/- 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) [] YELLOW 10 LAKE (CI 47005)

WARNINGS

WARNING: STOP USE IF IRRITATION OCCURS.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL:

MAC

TINTED LIP CONDITIONER SPF 15

15 ML/0.5 US FL OZ.

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

INGREDIENTS AND APPEARANCE

TINTED LIP CONDITIONER  SPF 15
octinoxate, octisalate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 40046-0051
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)
TRIETHOXYCAPRYLYLSILANE (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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 40046-0051-1	1 in 1 CARTON
1	NDC: 40046-0051-2	15 mL in 1 JAR

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

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