RE-NUTRIV- titanium dioxide cream

RE-NUTRIV by

Drug Labeling and Warnings

RE-NUTRIV 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]

WARNING

Keep out of eyes.

Stop use if irritation occurs.

Keep out of reach of children.

ACTIVE INGREDIENT

TITANIUM DIOXIDE 1.40%

INGREDIENTS

WATER\AQUA\EAU CYCLOPENTASILOXANE PHENYL TRIMETHICONE BUTYLENE GLYCOL CETYL DIMETHICONE DIMETHICONE PENTAERYTHRITYL TETRAETHYLHEXANOATE OCTYLDODECYL STEAROYL STEARATE PEG/PPG-18/18 DIMETHICONE CETYL PEG/PPG-10/1 DIMETHICONE MAGNESIUM SULFATE SILYBUM MARIANUM (LADY'S THISTLE) EXTRACT TOCOPHERYL ACETATE ASCORBYL PALMITATE CAFFEINE SODIUM HYALURONATE 7-DEHYDROCHOLESTEROL PHYTOSPHINGOSINE PEG-8 SUCROSE CHOLESTEROL LAURETH-7 LINOLEIC ACID HYDROGENATED LECITHIN METHICONE DISTEARDIMONIUM HECTORITE PALMITOYL OLIGOPEPTIDE XANTHAN GUM ZINC STEARATE TRIMETHYLSILOXYSILICATE GLYCERYL POLYMETHACRYLATE TRIETHYL CITRATE ALUMINA FRAGRANCE (PARFUM) BHT PHENOXYETHANOL CHLOROXYLENOL IMIDAZOLIDINYL UREA [+/- IRON OXIDES (CI 77491, CI 77492, CI 77499) TITANIUM DIOXIDE (CI 77891) MICA] <ILN36837>

PRINCIPAL DISPLAY PANEL - 30 ml CARTON

ESTĒE LAUDER
Re-Nutriv

Intensive Lifting Makeup
SPF 15

POIDS NET WT. 1.1 OZ./30 ml e

INGREDIENTS AND APPEARANCE

RE-NUTRIV   INTENSIVE LIFTNG MAKE UP SPF15
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-769
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.4 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
MILK THISTLE (UNII: 822I9LEJ7S)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CAFFEINE (UNII: 3G6A5W338E)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SUCROSE (UNII: C151H8M554)
CHOLESTEROL (UNII: 97C5T2UQ7J)
LAURETH-7 (UNII: Z95S6G8201)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)
XANTHAN GUM (UNII: TTV12P4NEE)
ZINC STEARATE (UNII: H92E6QA4FV)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
ALUMINUM OXIDE (UNII: LMI26O6933)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
IMIDUREA (UNII: M629807ATL)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-769-01	1 in 1 CARTON
1		30 mL in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/1999

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