Label: DOUBLE WEAR STAY IN PLACE SPF 10 MAKEUP- titanium dioxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 11559-729-01, 11559-729-02 - 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 October 4, 2011
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- ACTIVE INGREDIENT
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INDICATIONS & USAGE
INACTIVE INGREDIENTS: TALC [] ISOSTEARYL PALMITATE [] SILICA [] CALCIUM SILICATE [] BORON NITRIDE [] METHICONE [] TRIMETHYLSILOXYSILICATE [] PHENYL TRIMETHICONE [] POLYMETHYLSILSESQUIOXANE [] METHYL METHACRYLATE CROSSPOLYMER [] CAPRYLYL GLYCOL [] ADIPIC ACID/NEOPENTYL GLYCOL CROSSPOLYMER [] POLYPROPYLENE [] HEXYLENE GLYCOL [] PHENOXYETHANOL [] [+/- IRON OXIDES (CI 77491, CI 77492, CI 77499) [] MICA [] CHROMIUM OXIDE GREENS (CI 77288) [] CHROMIUM HYDROXIDE GREEN (CI 77289) [] CARMINE (CI 75470) [] BISMUTH OXYCHLORIDE (CI 77163) [] TITANIUM DIOXIDE (CI 77891)]
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INGREDIENTS AND APPEARANCE
DOUBLE WEAR STAY IN PLACE SPF 10 MAKEUP
titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11559-729 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4.0 g in 100 g Inactive Ingredients Ingredient Name Strength TALC (UNII: 7SEV7J4R1U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CALCIUM SILICATE (UNII: S4255P4G5M) BORON NITRIDE (UNII: 2U4T60A6YD) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) HEXYLENE GLYCOL (UNII: KEH0A3F75J) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) MICA (UNII: V8A1AW0880) CHROMIC OXIDE (UNII: X5Z09SU859) COCHINEAL (UNII: TZ8Z31B35M) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11559-729-01 1 in 1 CARTON 1 NDC:11559-729-02 12 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/01/2007 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
