Label: RESILIENCE LIFT FIRMING SCULPTING FACE AND NECK SPF15 NORMAL COMBO SKIN- octinoxate, titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 11559-013-01, 11559-013-02 - 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 July 1, 2011
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
INACTIVE NGREDIENTS: WATER [] CETYL ETHYLHEXANOATE [] BUTYLENE GLYCOL [] GLYCERYL STEARATE [] PEG-100 STEARATE [] OCTYLDODECYL NEOPENTANOATE [] GLYCERIN [] POLYETHYLENE [] HYDROGENATED LECITHIN [] PENTYLENE GLYCOL [] PLANKTON EXTRACT [] LAMINARIA DIGITATA EXTRACT [] BEHENYL ALCOHOL [] ALGAE EXTRACT [] PERSEA GRATISSIMA (AVOCADO) OIL [] CUCUMIS MELO (MELON) FRUIT EXTRACT [] POTASSIUM HYDROXIDE [] MIMOSA TENUIFLORA BARK EXTRACT [] YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE [] AMINOPROPYL ASCORBYL PHOSPHATE [] THERMUS THERMOPHILLUS FERMENT [] SACCHAROMYCES FERMENT LYSATE FILTRATE [] ARTEMIA EXTRACT [] CHOLESTEROL/POTASSIUM SULFATE [] ACETYL GLUCOSAMINE [] LINOLEIC ACID [] LECITHIN [] WHEY PROTEIN\LACTIS PROTEIN\PROTEINE DU PETIT-LAIT [] TOCOPHERYL ACETATE [] CAFFEINE [] ERGOTHIONEINE [] POLYMETHYL METHACRYLATE [] SODIUM HYALURONATE [] DECARBOXY CARNOSINE HCL [] STEARIC ACID [] ZINC PCA [] TREHALOSE [] DIETHYLHEXYL SYRINGYLIDENEMALONATE [] SORBITOL [] ACETYL HEXAPEPTIDE-8 [] CITRIC ACID [] HYDROGENATED STARCH HYDROLYSATE [] PROPYLENE GLYCOL DICAPRYLATE [] CAPRYLIC/CAPRIC TRIGLYCERIDE [] MALTODEXTRIN [] MALACHITE [] HEXYLENE GLYCOL [] ETHYLHEXYLGLYCERIN [] PHYTOSTEROLS [] CAPRYLYL GLYCOL [] CARBOMER [] SILICA [] ALUMINA [] FRAGRANCE (PARFUM) [] XANTHAN GUM [] DISODIUM EDTA [] BHT [] PHENOXYETHANOL [] POTASSIUM SORBATE [] SODIUM DEHYDROACETATE [] MICA [] TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499)
- WARNINGS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RESILIENCE LIFT FIRMING SCULPTING FACE AND NECK SPF15 NORMAL COMBO SKIN
octinoxate, titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11559-013 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 TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.4 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETYL ETHYLHEXANOATE (UNII: 134647WMX4) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) GLYCERIN (UNII: PDC6A3C0OX) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) PENTYLENE GLYCOL (UNII: 50C1307PZG) DOCOSANOL (UNII: 9G1OE216XY) SODIUM ALGINATE (UNII: C269C4G2ZQ) AVOCADO OIL (UNII: 6VNO72PFC1) MUSKMELON (UNII: ZV095H5633) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) MIMOSA TENUIFLORA BARK (UNII: 515MQE449I) YEAST (UNII: 3NY3SM6B8U) SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) CHOLESTEROL (UNII: 97C5T2UQ7J) POTASSIUM SULFATE (UNII: 1K573LC5TV) N-ACETYLGLUCOSAMINE (UNII: V956696549) LINOLEIC ACID (UNII: 9KJL21T0QJ) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) WHEY (UNII: 8617Z5FMF6) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CAFFEINE (UNII: 3G6A5W338E) ERGOTHIONEINE (UNII: BDZ3DQM98W) HYALURONATE SODIUM (UNII: YSE9PPT4TH) STEARIC ACID (UNII: 4ELV7Z65AP) ZINC PIDOLATE (UNII: C32PQ86DH4) TREHALOSE (UNII: B8WCK70T7I) SORBITOL (UNII: 506T60A25R) ACETYL HEXAPEPTIDE-3 (UNII: L4EL31FWIL) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PROPYLENE GLYCOL DICAPRYLATE (UNII: 581437HWX2) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) MALTODEXTRIN (UNII: 7CVR7L4A2D) HEXYLENE GLYCOL (UNII: KEH0A3F75J) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALUMINUM OXIDE (UNII: LMI26O6933) XANTHAN GUM (UNII: TTV12P4NEE) EDETATE DISODIUM (UNII: 7FLD91C86K) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PHENOXYETHANOL (UNII: HIE492ZZ3T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11559-013-01 1 in 1 CARTON 1 NDC:11559-013-02 50 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/01/2010 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
