NUTRITIOUS- titanium dioxide liquid

NUTRITIOUS by

Drug Labeling and Warnings

NUTRITIOUS by is a Otc medication manufactured, distributed, or labeled by Estee Lauder Inc., ELGC Kabushiki Kaisha, Estee Lauder Pennsylvania Distribution Center 2 (PADC 2), ARAMIS, INC, ESTEE LAUDER COSMETICS DISTRIBUTION CENTER, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTEC KEYSTONE, NORTHTEC BRISTOL, NORTHTEC KEYSTONE, WHITMAN LABORATORIES, LTD., Aveda Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

TITANIUM DIOXIDE 2.40%

INGREDIENTS

WATER CYCLOPENTASILOXANE PHENYL TRIMETHICONE GLYCERIN BUTYLENE GLYCOL HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER PEG-10 DIMETHICONE DIMETHICONE QUATERNIUM-90 BENTONITE SILICA OCTYLDODECYL STEAROYL STEARATE ETHYLHEXYLGLYCERIN PHENYL METHICONE PUNICA GRANATUM (POMEGRANATE) STEROLS POLYSILICONE-11 TRIFLUOROMETHYL C1-4 ALKYL DIMETHICONE POLYGLYCERYL-4 ISOSTEARATE HEXYL LAURATE CETYL PEG/PPG-10/1 DIMETHICONE C9-15 FLUOROALCOHOL PHOSPHATE LAURETH-7 LECITHIN PROPYLENE CARBONATE TOCOPHERYL ACETATE TRIETHOXYCAPRYLYLSILANE METHICONE TALC NYLON-12 ZINC STEARATE TETRAHEXYLDECYL ASCORBATE ALUMINA ZEOLITE SODIUM CHLORIDE XANTHAN GUM MAGNESIUM ALUMINUM SILICATE CALCIUM SILICATE DISODIUM EDTA POTASSIUM SORBATE SORBIC ACID SODIUM DEHYDROACETATE PHENOXYETHANOL CHLORPHENESIN [+/- TITANIUM DIOXIDE (CI 77891) MICA IRON OXIDES (CI 77491, CI 77492, CI 77499) ZINC OXIDE (CI 77947) CHROMIUM HYDROXIDE GREEN (CI 77289)]

WARNING

Keep out of eyes.

Stop use if irritation occurs.

Keep out of reach of children.

SPL UNCLASSIFIED SECTION

© ESTĒE LAUDER, DIST.
NEW YORK, N.Y. 10022

PRINCIPAL DISPLAY PANEL - 30 ml Carton

ESTĒE LAUDER

Nutritious
Vita-Mineral Makeup

SPF 10

1 FL. OZ. LIQ./30 ml e

INGREDIENTS AND APPEARANCE

NUTRITIOUS   VITA-MINERAL MAKEUP SPF 10
titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-739
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.4 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
LAURETH-7 (UNII: Z95S6G8201)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TALC (UNII: 7SEV7J4R1U)
ZINC STEARATE (UNII: H92E6QA4FV)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
XANTHAN GUM (UNII: TTV12P4NEE)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
CALCIUM SILICATE (UNII: S4255P4G5M)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SORBIC ACID (UNII: X045WJ989B)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-739-01	1 in 1 CARTON
1		30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	11/22/2008

Labeler - Estee Lauder Inc. (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC Kabushiki Kaisha		712808195	RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE, RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Business Operations
ARAMIS, INC		042918826	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 COSMETICS, LTD		253616536	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE

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
NORTEC KEYSTONE		787336577	MANUFACTURE, RELABEL, REPACK

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
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE