Label: STUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10- titanium dioxide liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 10348-001-01, 10348-001-02 - Packager: SMASHBOX BEAUTY 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 June 29, 2011
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS: WATER [] CYCLOPENTASILOXANE [] TRIMETHYLSILOXYSILICATE [] BUTYLENE GLYCOL [] TRIMETHYL PENTAPHENYL TRISILOXANE [] SILICA [] PHENYL TRIMETHICONE [] MAGNESIUM SULFATE [] POLYGLYCERYL-3 DIISOSTEARATE [] TRIBEHENIN [] PEG-10 DIMETHICONE [] BIS-PEG/PPG-14/14 DIMETHICONE [] TOCOPHERYL ACETATE [] SODIUM HYALURONATE [] GLYCERIN [] ETHYLHEXYLGLYCERIN [] POLYGLYCERYL-4 ISOSTEARATE [] CETYL PEG/PPG-10/1 DIMETHICONE [] METHICONE [] TETRAMETHYL HEXAPHENYL TETRASILOXANE [] PHENYL METHICONE [] DIMETHICONE [] LAURETH-7 [] POLYMETHYLSILSESQUIOXANE [] HEXYL LAURATE [] DISTEARDIMONIUM HECTORITE [] CELLULOSE GUM [] PROPYLENE CARBONATE [] ALUMINA [] XANTHAN GUM [] DIMETHICONE SILYLATE [] SORBIC ACID [] PHENOXYETHANOL [] CHLORPHENESIN [] [+/- IRON OXIDES (CI 77491, CI 77492, CI 77499) [] TITANIUM DIOXIDE (CI 77891)]
- WHEN USING
- WARNINGS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
STUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10
titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10348-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4.7 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) TRIBEHENIN (UNII: 8OC9U7TQZ0) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) GLYCERIN (UNII: PDC6A3C0OX) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) DIMETHICONE (UNII: 92RU3N3Y1O) LAURETH-7 (UNII: Z95S6G8201) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) HEXYL LAURATE (UNII: 4CG9F9W01Q) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) PROPYLENE CARBONATE (UNII: 8D08K3S51E) ALUMINUM OXIDE (UNII: LMI26O6933) XANTHAN GUM (UNII: TTV12P4NEE) SORBIC ACID (UNII: X045WJ989B) PHENOXYETHANOL (UNII: HIE492ZZ3T) CHLORPHENESIN (UNII: I670DAL4SZ) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10348-001-01 1 in 1 CARTON 1 NDC:10348-001-02 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2009 Labeler - SMASHBOX BEAUTY COSMETICS, INC (945344414) 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