RE-NUTRIV  INTENSIVE LIFTNG MAKE UP SPF15- titanium dioxide cream 
ESTEE LAUDER INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ESTĒE LAUDER
Re-Nutriv

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

Principal Display Panel  - 30 ml CARTON
RE-NUTRIV   INTENSIVE LIFTNG MAKE UP SPF15
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11559-769
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.4 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11559-769-011 in 1 CARTON
130 mL in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35212/01/1999
Labeler - ESTEE LAUDER INC (005914387)
Establishment
NameAddressID/FEIBusiness Operations
ELGC Kabushiki Kaisha712808195RELABEL, REPACK
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE, RELABEL, REPACK
Establishment
NameAddressID/FEIBusiness Operations
ARAMIS, INC042918826MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK, RELABEL
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
NORTEC KEYSTONE787336577MANUFACTURE, RELABEL, REPACK
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC BRISTOL949264774MANUFACTURE, RELABEL, REPACK
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC KEYSTONE618107429MANUFACTURE, RELABEL, REPACK
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058MANUFACTURE

Revised: 9/2011
Document Id: b15b2cb1-51f7-453d-b500-ea0a00851eec
Set id: 0391ab4c-28e6-4e13-94ca-6978e28929ad
Version: 1
Effective Time: 20110919
 
ESTEE LAUDER INC