NUTRITIOUS VITA MINERAL LOOSE POWDER MAKEUP SPF 15- titanium dioxide powder

NUTRITIOUS by

Drug Labeling and Warnings

NUTRITIOUS 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., Aveda Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT: TITANIUM DIOXIDE 2.10%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: TALC [] POLYMETHYLSILSESQUIOXANE [] HYDROGENATED POLYDECENE [] BORON NITRIDE [] CALCIUM ALUMINUM BOROSILICATE [] METHICONE [] TRIETHOXYCAPRYLYLSILANE [] MAGNESIUM MYRISTATE [] PHYTOSTEROLS [] TETRAHEXYLDECYL ASCORBATE [] ZEOLITE [] CAPRYLYL GLYCOL [] CALCIUM SILICATE [] HYDROGENATED STYRENE/ ISOPRENE COPOLYMER [] SODIUM CHLORIDE [] TOCOPHERYL ACETATE [] LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER [] HEXYLENE GLYCOL [] ZINC STEARATE [] SILICA [] POTASSIUM SORBATE [] PHENOXYETHANOL []  [+/- TITANIUM DIOXIDE (CI 77891) [] BISMUTH OXYCHLORIDE (CI 77163) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] MICA [] YELLOW 5 LAKE (CI 19140) [] FERRIC FERROCYANIDE (CI 77510) [] BLUE 1 LAKE (CI 42090) [] CHROMIUM OXIDE GREENS (CI 77288) [] CHROMIUM HYDROXIDE GREEN (CI 77289) [] CARMINE (CI 75470)]

WARNINGS

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

PRINCIPAL DISPLAY PANEL

ESTEE LAUDER

NUTRITIOUS

VITA-MINERAL LOOSE POWDER

MAKEUP

SPF 15

NT WT 0.52 OZ/15 g

DISTR ESTEE LAUDER INC

NEW YORK, NY 10022

INGREDIENTS AND APPEARANCE

NUTRITIOUS  VITA MINERAL LOOSE POWDER MAKEUP SPF 15
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-727
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
TALC (UNII: 7SEV7J4R1U)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
BORON NITRIDE (UNII: 2U4T60A6YD)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CALCIUM SILICATE (UNII: S4255P4G5M)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ZINC STEARATE (UNII: H92E6QA4FV)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MICA (UNII: V8A1AW0880)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FERRIC FERROCYANIDE (UNII: TLE294X33A)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CHROMIC OXIDE (UNII: X5Z09SU859)
COCHINEAL (UNII: TZ8Z31B35M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-727-01	1 in 1 CARTON
1	NDC: 11559-727-02	15 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/01/2010

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
Aveda Corporation		071352058	manufacture