Label: EQUALIZER- titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 11559-736-01 - 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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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INGREDIENTS
CYCLOPENTASILOXANE • WATER • BUTYLENE GLYCOL • POLYMETHYL METHACRYLATE • DIMETHICONE • ISOTETRACOSANE • HEXYLENE GLYCOL • PEG/PPG-18/18 DIMETHICONE • OCTYLDODECYL STEAROYL STEARATE • HYDROLYZED SOY PROTEIN • ISOSTEARYL NEOPENTANOATE • CHAMOMILLA RECUTITA (MATRICARIA) EXTRACT • LECITHIN • COCONUT ACID • DISTEARDIMONIUM HECTORITE • C9-15 FLUOROALCOHOL PHOSPHATE • POLYETHYLENE • LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER • POLYGLYCERYL-4 ISOSTEARATE • HEXYL LAURATE • CETYL PEG/PPG-10/1 DIMETHICONE • TOCOPHERYL LINOLEATE/OLEATE • SILICA • SODIUM CHLORIDE • LAURETH-7 • PROPYLENE CARBONATE • ALUMINA • DISODIUM EDTA • PHENOXYETHANOL • [+/- MICA • IRON OXIDES (CI 77491, CI 77492, CI 77499) • TITANIUM DIOXIDE (CI 77891) • CHROMIUM HYDROXIDE GREEN (CI 77289) • CHROMIUM OXIDE GREENS (CI 77288)]
- WARNING
- PRINCIPAL DISPLAY PANEL - 30 ml Carton
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INGREDIENTS AND APPEARANCE
EQUALIZER SMART MAKEUP SPF 10
titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11559-736 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 mL in 100 mL Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE (UNII: 92RU3N3Y1O) HEXYLENE GLYCOL (UNII: KEH0A3F75J) OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C) MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) COCONUT ACID (UNII: 40U37V505D) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) LAURETH-7 (UNII: Z95S6G8201) PROPYLENE CARBONATE (UNII: 8D08K3S51E) ALUMINUM OXIDE (UNII: LMI26O6933) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENOXYETHANOL (UNII: HIE492ZZ3T) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11559-736-01 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 12/26/2008 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
