Label: DOUBLE MATTE OIL CONTROL MAKEUP SPF 15- octinoxate liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 11559-732-01 - 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 29, 2011
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- ACTIVE INGREDIENT
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INGREDIENTS
WATER•CYCLOPENTASILOXANE•TRIMETHYLSILOXYSILICATE•BUTYLENE GLYCOL•SILICA•PEG/PPG-18/18 DIMETHICONE•POLYGLYCERYL-3 DIISOSTEARATE•MAGNESIUM SULFATE•TRIBEHENIN•HYDROLYZED SOY PROTEIN•COCONUT ACID•CHAMOMILLA RECUTITA (MATRICARIA) EXTRACT• URTICA DIOICA (NETTLE) EXTRACT•MELISSA OFFICINALIS (BALM MINT) EXTRACT•EQUISETUM HIEMALE (HORSETAIL) EXTRACT•AESCULUS HIPPOCASTANUM (HORSE CHESTNUT) BARK EXTRACT•ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT•SALVIA OFFICINALIS (SAGE) LEAF EXTRACT•PHENYL TRIMETHICONE•KAOLIN•PROPYLENE CARBONATE•METHICONE•TRIETHYL CITRATE•DISTEARDIMONIUM HECTORITE•LAURETH-7•CELLULOSE GUM•ALUMINA•DISODIUM EDTA•BHT•POTASSIUM SORBATE•PHENOXYETHANOL•[+/- MICA•TITANIUM DIOXIDE (CI 77891)•IRON OXIDES (CI 77491, CI 77492, CI 77499)]
- SPL UNCLASSIFIED SECTION
- WARNING
- PRINCIPAL DISPLAY PANEL - 30 ml Carton
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INGREDIENTS AND APPEARANCE
DOUBLE MATTE OIL CONTROL MAKEUP SPF 15
octinoxate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11559-732 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.2 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) TRIBEHENIN (UNII: 8OC9U7TQZ0) COCONUT ACID (UNII: 40U37V505D) MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) URTICA DIOICA LEAF (UNII: X6M0DRN46Q) MELISSA OFFICINALIS (UNII: YF70189L0N) EQUISETUM HYEMALE (UNII: 59677RXH25) AESCULUS HIPPOCASTANUM BARK (UNII: 7U76MXL14N) ROSEMARY (UNII: IJ67X351P9) SAGE (UNII: 065C5D077J) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) KAOLIN (UNII: 24H4NWX5CO) PROPYLENE CARBONATE (UNII: 8D08K3S51E) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) LAURETH-7 (UNII: Z95S6G8201) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) ALUMINUM OXIDE (UNII: LMI26O6933) EDETATE DISODIUM (UNII: 7FLD91C86K) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PHENOXYETHANOL (UNII: HIE492ZZ3T) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 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:11559-732-01 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 01/01/1998 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
