- WARNING
- ACTIVE INGREDIENT
-
INGREDIENTS
WATER (AQUA PURIFICATA) PURIFIED, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, SILICA, DIMETHICONE, PHENYL TRIMETHICONE, BIS-PEG/PPG-14/14 DIMETHICONE, MAGNESIUM SULFATE, TRIMETHYLSILOXYSILICATE, TITANIUM DIOXIDE, TOCOPHERYL ACETATE, RETINYL PALMITATE, ASCORBYL PALMITATE, DISTEARDIMONIUM HECTORITE, TRIETHOXYCAPRYLYLSILANE, POLYGLYCERYL-4 ISOSTEARATE, HEXYL LAURATE, CETYL PEG/PPG-10/1 DIMETHICONE, LAURETH-7, TRIETHYL CITRATE, PHENOXYETHANOL, METHYLPARABEN [+/-(MAY CONTAIN): MICA, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499), BISMUTH OXYCHLORIDE (CI 77163), CHROMIUM OXIDE GREENS (CI 77288)] <ILN28730>
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 ML Bottle Carton
-
INGREDIENTS AND APPEARANCE
MAC HYPER REAL SPF 15 FOUNDATION
octinoxate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:40046-0056 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIMETHICONE (UNII: 92RU3N3Y1O) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) MAGNESIUM SULFATE (UNII: DE08037SAB) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ASCORBYL PALMITATE (UNII: QN83US2B0N) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) LAURETH-7 (UNII: Z95S6G8201) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLPARABEN (UNII: A2I8C7HI9T) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) CHROMIC OXIDE (UNII: X5Z09SU859) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:40046-0056-1 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 06/01/2003 Labeler - MAKEUP ART COSMETICS (010597206) Establishment Name Address ID/FEI Business Operations ELGC K.K. 712808195 RELABEL(40046-0056) , REPACK(40046-0056) Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(40046-0056) , RELABEL(40046-0056) , REPACK(40046-0056) Establishment Name Address ID/FEI Business Operations Estee Lauder Inc. 042918826 MANUFACTURE(40046-0056) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(40046-0056) , RELABEL(40046-0056) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 253616536 MANUFACTURE(40046-0056) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(40046-0056) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(40046-0056) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(40046-0056) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(40046-0056) Establishment Name Address ID/FEI Business Operations NORTEC KEYSTONE 943871157 MANUFACTURE(40046-0056) , RELABEL(40046-0056) , REPACK(40046-0056) Establishment Name Address ID/FEI Business Operations NORTHTEC BRISTOL 959338336 MANUFACTURE(40046-0056) , RELABEL(40046-0056) , REPACK(40046-0056) Establishment Name Address ID/FEI Business Operations NORTHTEC KEYSTONE 949264774 MANUFACTURE(40046-0056) , RELABEL(40046-0056) , REPACK(40046-0056) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(40046-0056) Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 MANUFACTURE(40046-0056) Establishment Name Address ID/FEI Business Operations Pennsylvania Logistics Center 078364654 REPACK(40046-0056) , RELABEL(40046-0056)