Label: RESILIENCE LIFT EXTREME ULTRA FIRMING SPF 15- octinoxate, octisalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 11559-932-01, 11559-932-02 - 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 June 21, 2011
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS: WATER [] NEOPENTYL GLYCOL DIHEPTANOATE [] CETYL ALCOHOL [] GLYCERIN [] POLYETHYLENE [] DI-C12-15 ALKYL FUMARATE [] PETROLATUM [] HYDROGENATED LECITHIN [] BUTYLENE GLYCOL [] PENTYLENE GLYCOL [] OCTYLDODECYL MYRISTATE [] ISOCETYL ALCOHOL [] HYDROGENATED POLYISOBUTENE [] HEXYLDECYL STEARATE [] PENTAERYTHRITYL TETRAETHYLHEXANOATE [] BEHENYL ALCOHOL [] POTATO STARCH MODIFIED [] ALGAE EXTRACT [] OLEA EUROPAEA (OLIVE) FRUIT EXTRACT [] PERSEA GRATISSIMA (AVOCADO) OIL [] TRITICUM VULGARE (WHEAT BRAN) EXTRACT [] COLEUS BARBATUS EXTRACT [] CUCUMIS MELO (MELON) FRUIT EXTRACT [] ISOMERIZED LINOLEIC ACID [] DIMETHICONE [] MIMOSA TENUIFLORA BARK EXTRACT [] YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE [] AMINOPROPYL ASCORBYL PHOSPHATE [] THERMUS THERMOPHILLUS FERMENT [] C12-16 ALCOHOLS [] GLYCERYL STEARATE [] CHOLESTEROL/POTASSIUM SULFATE [] OCTYLDODECYL NEOPENTANOATE [] ACETYL GLUCOSAMINE [] LINOLEIC ACID [] PEG-100 STEARATE [] CAFFEINE [] GLYCINE SOJA (SOYBEAN) STEROLS [] PALMITIC ACID [] POLYMETHYL METHACRYLATE [] PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) SEED EXTRACT [] SODIUM HYALURONATE [] DECARBOXY CARNOSINE HCL [] ADENOSINE PHOSPHATE [] POTASSIUM SORBATE [] CREATINE [] TREHALOSE [] SORBITOL [] POLYSILICONE-11 [] ACETYL HEXAPEPTIDE-8 [] PROPYLENE GLYCOL DICAPRYLATE [] HYDROLYZED FISH (PISCES) COLLAGEN [] LECITHIN [] HYDROXYETHYLCELLULOSE [] MALTODEXTRIN [] HEXYLENE GLYCOL [] LAURDIMONIUM HYDROXYPROPYL HYDROLYZED SOY PROTEIN [] SODIUM STEARATE [] SODIUM CITRATE [] ALUMINUM STEARATE [] CAPRYLYL GLYCOL [] FRAGRANCE (PARFUM) [] XANTHAN GUM [] DISODIUM EDTA [] PHENOXYETHANOL [] MICA [] TITANIUM DIOXIDE (CI 77891) [] RED 4 (CI 14700) [] YELLOW 5 (CI 19140)
- WARNINGS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RESILIENCE LIFT EXTREME ULTRA FIRMING SPF 15
octinoxate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11559-932 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) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) PETROLATUM (UNII: 4T6H12BN9U) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PENTYLENE GLYCOL (UNII: 50C1307PZG) OCTYLDODECYL MYRISTATE (UNII: S013N99GR8) ISOCETYL ALCOHOL (UNII: 1800H64066) DOCOSANOL (UNII: 9G1OE216XY) STARCH, POTATO (UNII: 8I089SAH3T) OLIVE OIL (UNII: 6UYK2W1W1E) AVOCADO OIL (UNII: 6VNO72PFC1) WHEAT BRAN (UNII: 6L966A1IMR) PLECTRANTHUS BARBATUS ROOT (UNII: V5741391RG) CUCUMBER (UNII: YY7C30VXJT) DIMETHICONE (UNII: 92RU3N3Y1O) ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV) YEAST (UNII: 3NY3SM6B8U) C12-16 ALCOHOLS (UNII: S4827SZE3L) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CHOLESTEROL (UNII: 97C5T2UQ7J) POTASSIUM SULFATE (UNII: 1K573LC5TV) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) LINOLEIC ACID (UNII: 9KJL21T0QJ) PEG-100 STEARATE (UNII: YD01N1999R) CAFFEINE (UNII: 3G6A5W338E) SOY STEROL (UNII: PL360EPO9J) PALMITIC ACID (UNII: 2V16EO95H1) ALMOND OIL (UNII: 66YXD4DKO9) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ADENOSINE PHOSPHATE (UNII: 415SHH325A) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CREATINE (UNII: MU72812GK0) TREHALOSE (UNII: B8WCK70T7I) SORBITOL (UNII: 506T60A25R) ACETYL HEXAPEPTIDE-3 (UNII: L4EL31FWIL) PROPYLENE GLYCOL DICAPRYLATE (UNII: 581437HWX2) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) MALTODEXTRIN (UNII: 7CVR7L4A2D) HEXYLENE GLYCOL (UNII: KEH0A3F75J) SODIUM CITRATE (UNII: 1Q73Q2JULR) CAPRYLYL GLYCOL (UNII: 00YIU5438U) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENOXYETHANOL (UNII: HIE492ZZ3T) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C RED NO. 4 (UNII: X3W0AM1JLX) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11559-932-01 1 in 1 CARTON 1 NDC:11559-932-02 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 05/01/2008 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