Label: RESILIENCE LIFT FIRMING SCULPTING FACE AND NECK CREME SPF 15 NML COMBO- octinoxate, octisalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 11559-011-01, 11559-011-02 - 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 April 19, 2011
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS: WATER [] NEOPENTYL GLYCOL DIHEPTANOATE [] CETYL ALCOHOL [] PENTAERYTHRITYL TETRAETHYLHEXANOATE [] GLYCERIN [] POLYETHYLENE [] DI-C12-15 ALKYL FUMARATE [] PETROLATUM [] HYDROGENATED LECITHIN [] BUTYLENE GLYCOL [] PENTYLENE GLYCOL [] OCTYLDODECYL MYRISTATE [] HYDROGENATED POLYISOBUTENE [] HEXYLDECYL STEARATE [] DIMETHICONE [] LAMINARIA DIGITATA EXTRACT [] BEHENYL ALCOHOL [] POTATO STARCH MODIFIED [] ALGAE EXTRACT [] PERSEA GRATISSIMA (AVOCADO) OIL [] COLEUS BARBATUS EXTRACT [] CUCUMIS MELO (MELON) FRUIT EXTRACT [] MIMOSA TENUIFLORA BARK EXTRACT [] YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE [] PLANKTON EXTRACT [] AMINOPROPYL ASCORBYL PHOSPHATE [] THERMUS THERMOPHILLUS FERMENT [] SACCHAROMYCES FERMENT LYSATE FILTRATE [] ARTEMIA EXTRACT [] C12-16 ALCOHOLS [] GLYCERYL STEARATE [] CHOLESTEROL/POTASSIUM SULFATE [] OCTYLDODECYL NEOPENTANOATE [] ACETYL GLUCOSAMINE [] LINOLEIC ACID [] WHEY PROTEIN [] PEG-100 STEARATE [] TOCOPHERYL ACETATE [] CAFFEINE [] ERGOTHIONEINE [] GLYCINE SOJA (SOYBEAN) STEROLS [] PALMITIC ACID [] POLYMETHYL METHACRYLATE [] SODIUM HYALURONATE [] DECARBOXY CARNOSINE HCL [] STEARIC ACID [] POTASSIUM SORBATE [] CREATINE [] ZINC PCA [] GLUCOSE [] TREHALOSE [] DIETHYLHEXYL SYRINGYLIDENEMALONATE [] SORBITOL [] POLYSILICONE-11 [] ACETYL HEXAPEPTIDE-8 [] CITRIC ACID [] LACTOPEROXIDASE [] GLUCOSE OXIDASE [] HYDROGENATED STARCH HYDROLYSATE [] PROPYLENE GLYCOL DICAPRYLATE [] CAPRYLIC/CAPRIC TRIGLYCERIDE [] MALTODEXTRIN [] MALACHITE [] HEXYLENE GLYCOL [] ETHYLHEXYLGLYCERIN [] PHYTOSTEROLS [] CAPRYLYL GLYCOL [] SODIUM HYDROXIDE [] SILICA [] ALUMINA [] FRAGRANCE (PARFUM) [] XANTHAN GUM [] DISODIUM EDTA [] BHT [] PHENOXYETHANOL [] MICA [] TITANIUM DIOXIDE (CI 77891) [] RED 4 (CI 14700) [] YELLOW 5 (CI 19140)
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RESILIENCE LIFT FIRMING SCULPTING FACE AND NECK CREME SPF 15 NML COMBO
octinoxate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11559-011 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 3.5 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) PETROLATUM (UNII: 4T6H12BN9U) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PENTYLENE GLYCOL (UNII: 50C1307PZG) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) DIMETHICONE (UNII: 92RU3N3Y1O) LAMINARIA SACCHARINA (UNII: RTR3OGP8ET) AVOCADO OIL (UNII: 6VNO72PFC1) CUCUMBER (UNII: YY7C30VXJT) SEAWEED (UNII: 477TV3P5UX) SACCHAROMYCES LYSATE (UNII: R85W246Z1C) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CHOLESTEROL (UNII: 97C5T2UQ7J) GLUCOSAMINE (UNII: N08U5BOQ1K) LINOLEIC ACID (UNII: 9KJL21T0QJ) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) CAFFEINE (UNII: 3G6A5W338E) HYALURONATE SODIUM (UNII: YSE9PPT4TH) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CREATINE (UNII: MU72812GK0) TREHALOSE (UNII: B8WCK70T7I) SORBITOL (UNII: 506T60A25R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HEXYLENE GLYCOL (UNII: KEH0A3F75J) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) XANTHAN GUM (UNII: TTV12P4NEE) EDETATE DISODIUM (UNII: 7FLD91C86K) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PHENOXYETHANOL (UNII: HIE492ZZ3T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11559-011-01 1 in 1 CARTON 1 NDC:11559-011-02 50 mL in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2011 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
