THE TREATMENT POWDER FOUNDATION SPF 15- titanium dioxide, octinoxate powder

THE TREATMENT POWDER FOUNDATION by

Drug Labeling and Warnings

THE TREATMENT POWDER FOUNDATION by is a Otc medication manufactured, distributed, or labeled by MAX HUBER RESEARCH LAB 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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS: TITANIUM DIOXIDE, 4.9% [] OCTINOXATE 4.5%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: TALC [] DIMETHICONE [] SILICA [] BORON NITRIDE [] OCTYLDODECYL STEAROYL STEARATE [] NYLON-12 [] POLYMETHYL METHACRYLATE [] YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE [] POLYGLYCERYL-3 DIISOSTEARATE [] POLYPERFLUOROMETHYLISOPROPYL ETHER [] METHICONE [] MALACHITE [] TOURMALINE [] ZEOLITE [] CAPRYLYL GLYCOL [] ORYZANOL [] TOCOPHERYL ACETATE [] CALCIUM CARBONATE [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] HEXYLENE GLYCOL [] PHENOXYETHANOL [] SORBIC ACID []  [+/- MICA [] BISMUTH OXYCHLORIDE (CI 77163) [] TITANIUM DIOXIDE (CI 77891) [] ZINC OXIDE (CI 77947) [] IRON OXIDES (CI 77491, CI 77492, CI 77499)]

WARNINGS

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL:

skin color de la mer

LA MER

the treatment powder foundation

spf 15

nt wt. 0.35 oz./10 g

MAX HUBER RESEARCH LABS INC DISTR.

NEW YORK, NY 10022

INGREDIENTS AND APPEARANCE

THE TREATMENT POWDER FOUNDATION  SPF 15
titanium dioxide, octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65966-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.9 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BORON NITRIDE (UNII: 2U4T60A6YD)
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)
YEAST (UNII: 3NY3SM6B8U)
CUPRIC CARBONATE (UNII: 9AOA5F11GJ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GAMMA ORYZANOL (UNII: SST9XCL51M)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CALCIUM CARBONATE (UNII: H0G9379FGK)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SORBIC ACID (UNII: X045WJ989B)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
ZINC OXIDE (UNII: SOI2LOH54Z)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65966-111-01	1 in 1 CARTON
1	NDC: 65966-111-02	10 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2008

Labeler - MAX HUBER RESEARCH LAB INC (926708694)

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