Label: MINERALIZE SPF 15 FOUNDATION LOOSE- titanium dioxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 40046-0031-1, 40046-0031-2 - Packager: MAKEUP ART COSMETICS
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated September 12, 2011
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS: MICA [] HORDEUM DISTICHON (BARLEY) EXTRACT\EXTRAIT D'ORGE A DEUX RANGS [] TRITICUM VULGARE (WHEAT) GERM OIL [] ASCORBYL PALMITATE [] TOCOPHERYL ACETATE [] SQUALANE [] METHICONE [] POTASSIUM SORBATE [] CHLORPHENESIN [] [+/- TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] BISMUTH OXYCHLORIDE (CI 77163) [] BLUE 1 (CI 42090) [] CARMINE (CI 75470) [] CHROMIUM HYDROXIDE GREEN (CI 77289) [] CHROMIUM OXIDE GREENS (CI 77288) [] FERRIC FERROCYANIDE (CI 77510) [] YELLOW 5 LAKE (CI 19140) [] ZINC OXIDE (CI 77947)
- WARNINGS
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INGREDIENTS AND APPEARANCE
MINERALIZE SPF 15 FOUNDATION LOOSE
titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:40046-0031 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 7.0 g in 100 g Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880) BARLEY BRAN (UNII: 2TXV6Z67KP) WHEAT GERM OIL (UNII: 14C97E680P) ASCORBYL PALMITATE (UNII: QN83US2B0N) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SQUALANE (UNII: GW89575KF9) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CHLORPHENESIN (UNII: I670DAL4SZ) FERRIC OXIDE RED (UNII: 1K09F3G675) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) COCHINEAL (UNII: TZ8Z31B35M) CHROMIC OXIDE (UNII: X5Z09SU859) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) ALUMINUM OXIDE (UNII: LMI26O6933) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:40046-0031-1 1 in 1 CARTON 1 NDC:40046-0031-2 8.5 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/01/2007 Labeler - MAKEUP ART COSMETICS (010597206) 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 Establishment Name Address ID/FEI Business Operations CRYSTAL CLAIRE COSMETICS 205493484 manufacture