Label: STUDIO FOUNDATION SPF 15- octinoxate and titanium dioxide stick
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Contains inactivated NDC Code(s)
NDC Code(s): 40046-0057-1 - 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 August 16, 2012
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- WARNING
- ACTIVE INGREDIENTS
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INGREDIENTS
DI-PPG-3-MYRISTYL ETHER ADIPATE, PHENYL TRIMETHICONE, SILICA, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, DIMETHICONE, TRIBEHENIN, C20-40 ALCOHOLS, ISONONYL ISONONANOATE, OZOKERITE, ALOE BARBADENSIS LEAF EXTRACT, TOCOPHERYL ACETATE, ASCORBYL PALMITATE, RETINYL PALMITATE, LECITHIN, ALUMINUM STEARATE, TRIMETHYLSILOXYSILICATE, SORBITAN LAURATE, PROPYLENE GLYCOL LAURATE, PROPYLENE GLYCOL STEARATE, POLYSORBATE 20, STEARIC ACID [+/- TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499)] <ILN29118>
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 9 g Tube Carton
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INGREDIENTS AND APPEARANCE
STUDIO FOUNDATION SPF 15
octinoxate and titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:40046-0057 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 5 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.9 g in 100 g Inactive Ingredients Ingredient Name Strength DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIMETHICONE (UNII: 92RU3N3Y1O) TRIBEHENIN (UNII: 8OC9U7TQZ0) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASCORBYL PALMITATE (UNII: QN83US2B0N) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ALUMINUM STEARATE (UNII: U6XF9NP8HM) SORBITAN MONOLAURATE (UNII: 6W9PS8B71J) PROPYLENE GLYCOL MONOLAURATE (UNII: 668Z5835Z3) PROPYLENE GLYCOL STEARATE (UNII: MZM1I680W0) POLYSORBATE 20 (UNII: 7T1F30V5YH) STEARIC ACID (UNII: 4ELV7Z65AP) 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:40046-0057-1 1 in 1 CARTON 1 9 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 08/06/2003 Labeler - MAKEUP ART COSMETICS (010597206) Establishment Name Address ID/FEI Business Operations ELGC K.K. 712808195 RELABEL(40046-0057) , REPACK(40046-0057) Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(40046-0057) , RELABEL(40046-0057) , REPACK(40046-0057) Establishment Name Address ID/FEI Business Operations Estee Lauder Inc. 042918826 MANUFACTURE(40046-0057) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(40046-0057) , RELABEL(40046-0057) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 253616536 MANUFACTURE(40046-0057) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(40046-0057) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(40046-0057) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(40046-0057) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(40046-0057) Establishment Name Address ID/FEI Business Operations NORTEC KEYSTONE 943871157 MANUFACTURE(40046-0057) , RELABEL(40046-0057) , REPACK(40046-0057) Establishment Name Address ID/FEI Business Operations NORTHTEC BRISTOL 959338336 MANUFACTURE(40046-0057) , RELABEL(40046-0057) , REPACK(40046-0057) Establishment Name Address ID/FEI Business Operations NORTHTEC KEYSTONE 949264774 MANUFACTURE(40046-0057) , RELABEL(40046-0057) , REPACK(40046-0057) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(40046-0057) Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 MANUFACTURE(40046-0057) Establishment Name Address ID/FEI Business Operations Pennsylvania Logistics Center 078364654 REPACK(40046-0057) , RELABEL(40046-0057) Establishment Name Address ID/FEI Business Operations PRIVATE LABEL SELECT LTD 005415463 MANUFACTURE(40046-0057)
