Label: MAC SELECT TINT SPF 15- octinoxate liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 40046-0055-1 - Packager: MAKEUP ART COSMETICS
- 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 May 2, 2012
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- ACTIVE INGREDIENT
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INGREDIENTS
WATER\AQUA\EAU, DIMETHICONE, SILICA, CETYL DIMETHICONE, PHENYL TRIMETHICONE, BUTYLENE GLYCOL, POLYDECENE, GLYCERYL DILAURATE, ISOSTEARIC ACID, TROMETHAMINE, TOCOPHERYL ACETATE, SODIUM HYALURONATE, SUCROSE, HYDROGENATED LECITHIN, CAFFEINE, LINOLEIC ACID, XANTHAN GUM, CELLULOSE GUM, CHOLESTEROL, POLYETHYLENE, MAGNESIUM ALUMINUM SILICATE, PEG-9 DIMETHICONE, ETHYLHEXYLGLYCERIN, CAPRYLYL GLYCOL, HEXYLENE GLYCOL, TETRADIBUTYL PENTAERITHRITYL HYDROXYHYDROCINNAMATE, STEARETH-21, STEARETH-2, STEARIC ACID, POLYPERFLUOROMETHYLISOPROPYL ETHER, TETRASODIUM EDTA, BENZOIC ACID, DEHYDROACETIC ACID, PHENOXYETHANOL [+/- MICA, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499), CHROMIUM OXIDE GREENS (CI 77288)] <ILN32363>
- WARNING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 ML Bottle Carton
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INGREDIENTS AND APPEARANCE
MAC SELECT TINT SPF 15
octinoxate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:40046-0055 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERYL DILAURATE (UNII: MFL3ZIE8SK) ISOSTEARIC ACID (UNII: X33R8U0062) TROMETHAMINE (UNII: 023C2WHX2V) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SUCROSE (UNII: C151H8M554) CAFFEINE (UNII: 3G6A5W338E) LINOLEIC ACID (UNII: 9KJL21T0QJ) XANTHAN GUM (UNII: TTV12P4NEE) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) CHOLESTEROL (UNII: 97C5T2UQ7J) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HEXYLENE GLYCOL (UNII: KEH0A3F75J) STEARETH-21 (UNII: 53J3F32P58) STEARETH-2 (UNII: V56DFE46J5) STEARIC ACID (UNII: 4ELV7Z65AP) EDETATE SODIUM (UNII: MP1J8420LU) BENZOIC ACID (UNII: 8SKN0B0MIM) DEHYDROACETIC ACID (UNII: 2KAG279R6R) PHENOXYETHANOL (UNII: HIE492ZZ3T) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) CHROMIC OXIDE (UNII: X5Z09SU859) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:40046-0055-1 1 in 1 CARTON 1 50 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 08/01/2002 Labeler - MAKEUP ART COSMETICS (010597206) Establishment Name Address ID/FEI Business Operations ELGC K.K. 712808195 RELABEL(40046-0055) , REPACK(40046-0055) Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(40046-0055) , RELABEL(40046-0055) , REPACK(40046-0055) Establishment Name Address ID/FEI Business Operations Estee Lauder Inc. 042918826 MANUFACTURE(40046-0055) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 RELABEL(40046-0055) , REPACK(40046-0055) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 253616536 MANUFACTURE(40046-0055) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(40046-0055) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(40046-0055) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(40046-0055) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(40046-0055) Establishment Name Address ID/FEI Business Operations NORTEC KEYSTONE 943871157 MANUFACTURE(40046-0055) , RELABEL(40046-0055) , REPACK(40046-0055) Establishment Name Address ID/FEI Business Operations NORTHTEC BRISTOL 959338336 MANUFACTURE(40046-0055) , RELABEL(40046-0055) , REPACK(40046-0055) Establishment Name Address ID/FEI Business Operations NORTHTEC KEYSTONE 949264774 MANUFACTURE(40046-0055) , RELABEL(40046-0055) , REPACK(40046-0055) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(40046-0055) Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 MANUFACTURE(40046-0055) Establishment Name Address ID/FEI Business Operations Pennsylvania Logistics Center 078364654 REPACK(40046-0055) , RELABEL(40046-0055)
