Label: SKIN FOUNDATION MINERAL MAKEUP SPF 15- titanium dioxide, octinoxate powder
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Contains inactivated NDC Code(s)
NDC Code(s): 64141-111-01, 64141-111-02 - Packager: Bobbi Brown Professional Cosmetics 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 September 19, 2011
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS: VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER [] HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER [] POLYSILICONE-11 [] SILICA [] POLYMETHYLSILSESQUIOXANE [] PHENYL TRIMETHICONE [] GLYCINE SOJA (SOYBEAN) SEED EXTRACT [] PANTHENOL [] CERAMIDE 2 [] CERAMIDE 3 [] GLYCERIN [] ERGOTHIONEINE [] SODIUM HYALURONATE [] C9-15 FLUOROALCOHOL PHOSPHATE [] TRIMETHYLSILOXYSILICATE [] TOCOPHERYL ACETATE [] ASCORBYL PALMITATE [] CAPRYLYL GLYCOL [] ASCORBYL TOCOPHERYL MALEATE [] MAGNESIUM STEARATE [] NYLON-12 [] LAURETH-12 [] ALUMINA [] AMINOPROPYL ASCORBYL PHOSPHATE [] ALUMINUM HYDROXIDE [] [+/- MICA [] TITANIUM DIOXIDE (CI 77891) [] ZINC OXIDE (CI 77947) [] IRON OXIDES (CI 77491, CI 77492, CI 77499)
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INGREDIENTS AND APPEARANCE
SKIN FOUNDATION MINERAL MAKEUP SPF 15
titanium dioxide, octinoxate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64141-111 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 7.8 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.6 g in 100 g Inactive Ingredients Ingredient Name Strength POLYSILICONE-15 (UNII: F8DRP5BB29) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) SOYBEAN (UNII: L7HT8F1ZOD) PANTHENOL (UNII: WV9CM0O67Z) CERAMIDE 2 (UNII: C04977SRJ5) CERAMIDE 3 (UNII: 4370DF050B) GLYCERIN (UNII: PDC6A3C0OX) ERGOTHIONEINE (UNII: BDZ3DQM98W) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TRIMETHYLSILANE (UNII: 9L70DJH2K0) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASCORBYL PALMITATE (UNII: QN83US2B0N) CAPRYLYL GLYCOL (UNII: 00YIU5438U) MAGNESIUM STEARATE (UNII: 70097M6I30) LAURETH-12 (UNII: OAH19558U1) ALUMINUM OXIDE (UNII: LMI26O6933) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) MICA (UNII: V8A1AW0880) ZINC OXIDE (UNII: SOI2LOH54Z) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64141-111-01 1 in 1 CARTON 1 NDC:64141-111-02 6 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/01/2011 Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279) 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 Aramis Inc. 042918826 manufacture 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 Estee Lauder Pennsylvania Distribution Center 2 828534516 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics, Ltd. 255175580 manufacture Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics, Ltd 253616536 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 Kabushiki Kaisha 712808195 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
