DOUBLE WEAR MINERAL RICH LOOSE POWDER MAKEUP SPF 12- titanium dioxide powder

DOUBLE WEAR by

Drug Labeling and Warnings

DOUBLE WEAR by is a Otc medication manufactured, distributed, or labeled by ESTEE LAUDER 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., INTERCOS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT: TITANIUM DIOXIDE 2.2%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: TALC [] ZINC STEARATE [] CAPRYLYL METHICONE [] OCTYLDODECYL STEAROYL STEARATE [] BIS-HYDROXYETHOXYPROPYL DIMETHICONE/IPDI COPOLYMER ETHYLCARBAMTE [] CAPRYLYL GLYCOL [] HEXYLENE GLYCOL [] DEHYDROACETIC ACID []  [+/- MICA [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] ZINC OXIDE (CI 77947) [] TITANIUM DIOXIDE (CI 77891) [] YELLOW 5 LAKE (CI 19140) [] CHROMIUM OXIDE GREENS (CI 77288) [] CHROMIUM HYDROXIDE GREEN (CI 77289) [] FERRIC FERROCYANIDE (CI 77510) [] CARMINE (CI 75470) [] BISMUTH OXYCHLORIDE (CI 77163) [] BLUE 1 LAKE (CI 42090)]

WARNINGS

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL:

ESTEE LAUDER

DOUBLE WEAR

MINERAL RICH LOOSE POWDER MAKEUP

SPF 12

NT WT 0.39 OZ/ 11 g

ESTEE LAUDER DIST

NEW YORK, NY 10022

INGREDIENTS AND APPEARANCE

DOUBLE WEAR  MINERAL RICH LOOSE POWDER MAKEUP SPF 12
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
ZINC STEARATE (UNII: H92E6QA4FV)
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
MICA (UNII: V8A1AW0880)
ZINC OXIDE (UNII: SOI2LOH54Z)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
CHROMIC OXIDE (UNII: X5Z09SU859)
COCHINEAL (UNII: TZ8Z31B35M)
FERRIC FERROCYANIDE (UNII: TLE294X33A)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-014-01	1 in 1 CARTON
1	NDC: 11559-014-02	11 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/01/2010

Labeler - ESTEE LAUDER INC (005914387)

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
INTERCOS		071352058	manufacture