NDC | 11559-727-01, 11559-727-02 |
Set ID | bd1b687b-6062-4a0d-9d3c-dc7ea63f3a42 |
Category | HUMAN OTC DRUG LABEL |
Packager | ESTEE LAUDER INC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS: TALC [] POLYMETHYLSILSESQUIOXANE [] HYDROGENATED POLYDECENE [] BORON NITRIDE [] CALCIUM ALUMINUM BOROSILICATE [] METHICONE [] TRIETHOXYCAPRYLYLSILANE [] MAGNESIUM MYRISTATE [] PHYTOSTEROLS [] TETRAHEXYLDECYL ASCORBATE [] ZEOLITE [] CAPRYLYL GLYCOL [] CALCIUM SILICATE [] HYDROGENATED STYRENE/ ISOPRENE COPOLYMER [] SODIUM CHLORIDE [] TOCOPHERYL ACETATE [] LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER [] HEXYLENE GLYCOL [] ZINC STEARATE [] SILICA [] POTASSIUM SORBATE [] PHENOXYETHANOL [] [+/- TITANIUM DIOXIDE (CI 77891) [] BISMUTH OXYCHLORIDE (CI 77163) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] MICA [] YELLOW 5 LAKE (CI 19140) [] FERRIC FERROCYANIDE (CI 77510) [] BLUE 1 LAKE (CI 42090) [] CHROMIUM OXIDE GREENS (CI 77288) [] CHROMIUM HYDROXIDE GREEN (CI 77289) [] CARMINE (CI 75470)]
- WARNINGS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NUTRITIOUS VITA MINERAL LOOSE POWDER MAKEUP SPF 15
titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11559-727 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.1 g in 100 g Inactive Ingredients Ingredient Name Strength HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7) TALC (UNII: 7SEV7J4R1U) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) BORON NITRIDE (UNII: 2U4T60A6YD) DIMETHICONE (UNII: 92RU3N3Y1O) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) MAGNESIUM MYRISTATE (UNII: Z1917F0578) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CALCIUM SILICATE (UNII: S4255P4G5M) SODIUM CHLORIDE (UNII: 451W47IQ8X) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HEXYLENE GLYCOL (UNII: KEH0A3F75J) ZINC STEARATE (UNII: H92E6QA4FV) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) MICA (UNII: V8A1AW0880) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FERRIC FERROCYANIDE (UNII: TLE294X33A) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) CHROMIC OXIDE (UNII: X5Z09SU859) COCHINEAL (UNII: TZ8Z31B35M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11559-727-01 1 in 1 CARTON 1 NDC:11559-727-02 15 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/01/2010 Labeler - ESTEE LAUDER INC (005914387) 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