LIP CONDITIONER SPF 15- octinoxate, octisalate, titanium dioxide lipstick

LIP CONDITIONER by

Drug Labeling and Warnings

LIP CONDITIONER by is a Otc medication manufactured, distributed, or labeled by MAKE UP ART COSMETICS, 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, MANA COSMETICS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS: OCTINOXATE 7.50% [] OCTISALATE 5.00% [] TITANIUM DIOXIDE 1.00%

INACTIVE INGREDIENT

INGREDIENTS: RICINUS COMMUNIS (CASTOR) SEED OIL [] CANOLA OIL\HUILE DE COLZA [] DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE/HEXASTEARATE/HEXAROSINATE [] OZOKERITE [] GLYCERYL ROSINATE [] CETYL LACTATE [] EUPHORBIA CERIFERA (CANDELILLA) WAX\CANDELILLA CERA\CIRE DE CANDELILLA [] MYRISTYL LACTATE [] CETYL ACETATE [] BEESWAX\CERA ALBA\CIRE D’ABEILLE [] FRAGRANCE (PARFUM) [] SILICA [] ZEA MAYS (CORN) STARCH [] PERSEA GRATISSIMA (AVOCADO) OIL [] TRITICUM VULGARE (WHEAT) GERM OIL [] PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL [] BUTYROSPERMUM PARKII (SHEA BUTTER) [] HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL [] ANTHEMIS NOBILIS (CHAMOMILE) FLOWER EXTRACT [] ASTROCARYUM MURUMURU BUTTER [] TOCOPHEROL [] TOCOPHERYL ACETATE [] ASCORBYL PALMITATE [] RETINYL PALMITATE [] POLYDECENE [] SACCHARIN [] BISABOLOL

WARNINGS

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL:

MAC

LIP CONDITIONER STICK

SPF 15

4.8 g/0.16 oz

distr make up art cosmetics

Toronto, Ontario

Canada m5v 1r7

INGREDIENTS AND APPEARANCE

LIP CONDITIONER  SPF 15
octinoxate, octisalate, titanium dioxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 40046-0053
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CASTOR OIL (UNII: D5340Y2I9G)
CERESIN (UNII: Q1LS2UJO3A)
CANDELILLA WAX (UNII: WL0328HX19)
MYRISTYL LACTATE (UNII: 1D822OC34X)
YELLOW WAX (UNII: 2ZA36H0S2V)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
AVOCADO OIL (UNII: 6VNO72PFC1)
WHEAT GERM OIL (UNII: 14C97E680P)
ALMOND OIL (UNII: 66YXD4DKO9)
SHEA BUTTER (UNII: K49155WL9Y)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SACCHARIN (UNII: FST467XS7D)
LEVOMENOL (UNII: 24WE03BX2T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 40046-0053-1	1 in 1 CARTON
1	NDC: 40046-0053-2	4.8 g in 1 CARTRIDGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2005

Labeler - MAKE UP ART COSMETICS (010597206)

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
MANA COSMETICS INC		078870292	manufacture