ILLUMINATING FINISH- titanium dioxide, octinoxate powder

ILLUMINATING FINISH by

Drug Labeling and Warnings

ILLUMINATING FINISH 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:  TITANIUM DIOXIDE 6.30% [] OCTINOXATE 3.00%

INACTIVE INGREDIENTS:

TALC [] SILICA [] ZINC STEARATE [] OCTYLDODECYL STEAROYL STEARATE [] HYDROGENATED COCO-GLYCERIDES [] NELUMBIUM SPECIOSUM FLOWER EXTRACT [] TRIETHOXYCAPRYLYLSILANE [] PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE [] DIMETHICONE [] CAPRYLYL GLYCOL [] HEXYLENE GLYCOL [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] DEHYDROACETIC ACID []  [+/- BISMUTH OXYCHLORIDE (CI 77163) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] YELLOW 5 LAKE (CI 19140) [] YELLOW 6 LAKE (CI 15985) [] TITANIUM DIOXIDE (CI 77891) [] MICA [] RED 30 LAKE (CI 73360)]

WHEN USING

DIRECTIONS: FOR MEDIUM COVERAGE APPLY WITH DRY SPONGE. FOR FULL COVERAGE APPLY WITH DAMPENED SPONGE.

WARNINGS

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL:

BOBBI BROWN

ILLUMINATING FINISH POWDER
COMPACT FOUNDATION SPF 12

0.45 OZ/13 g



DIST. BOBBI BROWN PROFESSIONAL COSMETICS INC
NEW YORK, NY 10022

INGREDIENTS AND APPEARANCE

ILLUMINATING FINISH   COMPACT FOUNDATION SPF 12
titanium dioxide, octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64141-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6.3 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.0 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64141-007-01	1 in 1 CARTON
1	NDC: 64141-007-02	13 g in 1 CASE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/01/2010

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