Label: TRACELESS SKIN RESPONSIVE TINT- octinoxate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 59158-731-01, 59158-731-02 - Packager: PRESCRIPTIVES 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 April 5, 2011
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
WATER [] PHENYL TRIMETHICONE [] SILICA [] DIMETHICONE [] CETYL DIMETHICONE [] BUTYLENE GLYCOL [] POLYDECENE [] GLYCERYL DILAURATE [] ISOSTEARIC ACID [] CERAMIDE 2 [] SODIUM HYALURONATE [] ACETYL HEXAPEPTIDE-8 [] CAFFEINE [] SUCROSE [] HYDROGENATED LECITHIN [] TOCOPHERYL ACETATE [] CHOLESTEROL [] LINOLEIC ACID [] PEG-9 DIMETHICONE [] STEARETH-21 [] STEARETH-2 [] STEARIC ACID [] CITRUS AURANTIUM DULCIS (ORANGE) [] METHYLDIHYDROJASMONATE [] DIMETHYL OCTENOL [] PHENETHYL ALCOHOL [] FLORALOZONE [] POLYPERFLUOROMETHYLISOPROPYL ETHER [] MAGNESIUM ALUMINUM SILICATE [] CELLULOSE GUM [] XANTHAN GUM [] TROMETHAMINE [] TETRASODIUM EDTA [] BHT [] PHENOXYETHANOL [] CHLOROXYLENOL [] [+/- MICA [] TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499)
- WARNINGS
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INGREDIENTS AND APPEARANCE
TRACELESS SKIN RESPONSIVE TINT
octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59158-731 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.0 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ISOSTEARIC ACID (UNII: X33R8U0062) HYALURONATE SODIUM (UNII: YSE9PPT4TH) CAFFEINE (UNII: 3G6A5W338E) SUCROSE (UNII: C151H8M554) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) CHOLESTEROL (UNII: 97C5T2UQ7J) LINOLEIC ACID (UNII: 9KJL21T0QJ) XANTHAN GUM (UNII: TTV12P4NEE) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59158-731-01 1 in 1 CARTON 1 NDC:59158-731-02 30 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/01/2001 Labeler - PRESCRIPTIVES INC. (151701588) 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
