Label: DOUBLE WEAR MINERAL RICH LOOSE POWDER MAKEUP SPF 12- titanium dioxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 11559-014-01, 11559-014-02 - Packager: ESTEE LAUDER 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 November 11, 2011
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS: TALC [] ZINC STEARATE [] CAPRYLYL METHICONE [] OCTYLDODECYL STEAROYL STEARATE [] BIS-HYDROXYETHOXYPROPYL DIMETHICONE/IPDI COPOLYMER ETHYLCARBAMTE [] CAPRYLYL GLYCOL [] HEXYLENE GLYCOL [] DEHYDROACETIC ACID [] [+/- MICA [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] ZINC OXIDE (CI 77947) [] TITANIUM DIOXIDE (CI 77891) [] YELLOW 5 LAKE (CI 19140) [] CHROMIUM OXIDE GREENS (CI 77288) [] CHROMIUM HYDROXIDE GREEN (CI 77289) [] FERRIC FERROCYANIDE (CI 77510) [] CARMINE (CI 75470) [] BISMUTH OXYCHLORIDE (CI 77163) [] BLUE 1 LAKE (CI 42090)]
- WARNINGS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DOUBLE WEAR MINERAL RICH LOOSE POWDER MAKEUP SPF 12
titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11559-014 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.2 g in 100 g Inactive Ingredients Ingredient Name Strength TALC (UNII: 7SEV7J4R1U) ZINC STEARATE (UNII: H92E6QA4FV) OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HEXYLENE GLYCOL (UNII: KEH0A3F75J) DEHYDROACETIC ACID (UNII: 2KAG279R6R) MICA (UNII: V8A1AW0880) ZINC OXIDE (UNII: SOI2LOH54Z) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) CHROMIC OXIDE (UNII: X5Z09SU859) COCHINEAL (UNII: TZ8Z31B35M) FERRIC FERROCYANIDE (UNII: TLE294X33A) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11559-014-01 1 in 1 CARTON 1 NDC:11559-014-02 11 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/01/2010 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 INTERCOS 071352058 manufacture
