THE RADIANT CONCEALER SPF 15- titanium dioxide cream

THE RADIANT CONCEALER by

Drug Labeling and Warnings

THE RADIANT CONCEALER 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, Toshiki Pigment Company Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT: TITANIUM DIOXIDE 4.65%

INACTIVE INGREDIENT

INGREDIENTS: ISOCETYL MYRISTATE [] METHYL METHACRYLATE CROSSPOLYMER [] DIISOSTEARYL MALATE [] COPERNICIA CERIFERA (CARNAUBA) WAX\CERA CARNAUBA\CIRE DE CARNAUBA [] POLYGLYCERYL-2 OLEATE [] EUPHORBIA CERIFERA (CANDELILLA) WAX\CANDELILLA CERA\CIRE DE CANDELILLA [] ALUMINUM HYDROXIDE [] POLYETHYLENE [] TOCOPHEROL [] TOCOPHERYL ACETATE [] ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT [] GLYCINE SOJA (SOYBEAN) OIL [] PHAEODACTYLUM TRICORNOTUM EXTRACT [] SANTALUM ALBUM SEED EXTRACT [] PORIA COCOS SCLEROTIUM EXTRACT [] SODIUM RNA [] TOURMALINE [] DIMETHICONE SILYLATE [] DIMETHICONE [] CALCIUM CARBONATE [] MALACHITE [] PHYTOSPHINGOSINE [] CAPRYLIC/CAPRIC TRIGLYCERIDE [] ALLYL METHACRYLATES CROSSPOLYMER [] BISABOLOL [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] ISOPROPYL TITANIUM TRIISOSTEARATE [] HYDROGENATED COTTONSEED OIL [] TIN OXIDE [] ALUMINA [] SILICA []  [+/- MICA [] TITANIUM DIOXIDE (CI 77891) [] 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 RADIANT CONCEALER SPF 25

NT WT. 0.11 OZ/3.5 g

MAX HUBER RESEARCH LABS INC DISTR

NEW YORK, NY 10022

INGREDIENTS AND APPEARANCE

THE RADIANT CONCEALER  SPF 15
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65966-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.65 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
METHYL METHACRYLATE (UNII: 196OC77688)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ROSEMARY (UNII: IJ67X351P9)
SOYBEAN OIL (UNII: 241ATL177A)
SEAWEED (UNII: 477TV3P5UX)
FU LING (UNII: XH37TWY5O4)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CALCIUM CARBONATE (UNII: H0G9379FGK)
CUPRIC CARBONATE (UNII: 9AOA5F11GJ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
LEVOMENOL (UNII: 24WE03BX2T)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)
STANNIC OXIDE (UNII: KM7N50LOS6)
ALUMINUM OXIDE (UNII: LMI26O6933)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65966-010-01	1 in 1 CARTON
1	NDC: 65966-010-02	3.5 g 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 - 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

Establishment
Name	Address	ID/FEI	Business Operations
Toshiki Pigment Company Limited		690723812	manufacture