RICH LIP COLOR SPF 12- octinoxate, octisalate lipstick

RICH LIP COLOR by

Drug Labeling and Warnings

RICH LIP COLOR by is a Otc medication manufactured, distributed, or labeled by Bobbi Brown Professional Cosmetics Inc., 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, Intercos . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS: OCTINOXATE 5.00% [] OCTISALATE 2.50%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: OCTYLDODECANOL [] TRIISOSTEARIN [] DIISOSTEARYL MALATE [] DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE [] MICROCRYSTALLINE WAX [] POLYETHYLENE [] POLYBUTENE [] PARAFFIN [] VP/HEXADECENE COPOLYMER [] CAPRYLIC/CAPRIC TRIGLYCERIDE [] HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER [] OZOKERITE [] DICALCIUM PHOSPHATE [] IRVINGIA GABONENSIS KERNEL BUTTER [] OCTYLDODECYL PCA [] HYDROGENATED COCO-GLYCERIDES [] DIPALMITOYL HYDROXYPROLINE [] STEARALKONIUM BENTONITE [] ETHYL VANILLIN [] PROPYLENE CARBONATE [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] TOCOPHEROL [] SILICA []  [+/- MICA [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] RED 7 LAKE (CI 15850) [] BLUE 1 LAKE (CI 42090) [] YELLOW 5 LAKE (CI 19140) [] YELLOW 10 (CI 47005) [] RED 22 LAKE (CI 45380) [] RED 30 LAKE (CI 73360) [] CARMINE (CI 75470) [] TITANIUM DIOXIDE (CI 77891) [] RED 30 (CI 73360) [] RED 6 (CI 15850) [] YELLOW 6 LAKE (CI 15985) [] RED 33 LAKE (CI 17200) [] RED 21 (CI 45380) [] ORANGE 5 (CI 45370) [] RED 28 LAKE (CI 45410) [] YELLOW 5 (CI 19140) [] YELLOW 10 LAKE (CI 47005) [] BRONZE POWDER (CI 77400) [] RED 22 (CI 45380)

WARNINGS

WARNING: STOP USE IF IRRITATION OCCURS.

PRINCIPAL DISPLAY PANEL

BOBBI BROWN

RICH LIP COLOR SPF 12

NET WT. 0.13 oz/ 3.8 g

Distr. Bobbi Brown Professional Cosmetics

New York, NY 10022

INGREDIENTS AND APPEARANCE

RICH LIP COLOR  SPF 12
octinoxate, octisalate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64141-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5.0 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
PARAFFIN (UNII: I9O0E3H2ZE)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
IRVINGIA GABONENSIS SEED (UNII: 0J4W1PR213)
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
VANILLIN (UNII: CHI530446X)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
TOCOPHEROL (UNII: R0ZB2556P8)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
COCHINEAL (UNII: TZ8Z31B35M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64141-009-01	1 in 1 CARTON
1	NDC: 64141-009-02	3.8 g in 1 CARTRIDGE

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

Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)

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
Intercos		338578473	manufacture