RESILIENCE LIFT FIRMING SCULPTING FACE AND NECK SPF15 NORMAL COMBO SKIN- octinoxate, titanium dioxide lotion 
ESTEE LAUDER INC

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.

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ACTIVE INGREDIENTS: OCTINOXATE 7.50% [] TITANIUM DIOXIDE 1.40%

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)

WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL:


ESTEE LAUDER

RESILIENCE LIFT

FIRMING/SCULPTING FACE AND NECK

LOTION

SPF15

NORMAL/COMBO SKIN

NET WT. 1.7 OZ LIQ/50 ML



ESTEE LAUDER, DISTR

NEW YORK, NY 10022

FOLDING CARTON

RESILIENCE LIFT  FIRMING SCULPTING FACE AND NECK SPF15 NORMAL COMBO SKIN
octinoxate, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11559-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.4 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11559-013-011 in 1 CARTON
1NDC:11559-013-0250 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/01/2010
Labeler - ESTEE LAUDER INC (005914387)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD205952385manufacture
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326manufacture
Establishment
NameAddressID/FEIBusiness Operations
Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aramis Inc.042918826manufacture
Establishment
NameAddressID/FEIBusiness Operations
Northtec Bristol949264774manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Northtec Keystone618107429manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd.255175580manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd253616536manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Distribution Center208579636repack, relabel
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Kabushiki Kaisha712808195relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Whitman Laboratories Ltd.216866277manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058manufacture

Revised: 7/2011
Document Id: a5160066-95d9-4184-9452-bd120e3d66fe
Set id: 649b623a-5792-4935-8730-bae67a4dcc28
Version: 1
Effective Time: 20110701
 
ESTEE LAUDER INC