Label: RE-NUTRIV- titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 11559-769-01 - Packager: ESTEE LAUDER INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated September 19, 2011
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- Official Label (Printer Friendly)
- WARNING
- ACTIVE INGREDIENT
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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
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INGREDIENTS AND APPEARANCE
RE-NUTRIV INTENSIVE LIFTNG MAKE UP SPF15
titanium dioxide creamProduct 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
