Label: NUTRITIOUS- titanium dioxide liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 11559-739-01 - 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 October 28, 2011
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- ACTIVE INGREDIENT
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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
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 ml Carton
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INGREDIENTS AND APPEARANCE
NUTRITIOUS VITA-MINERAL MAKEUP SPF 10
titanium dioxide liquidProduct 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
