RESILIENCE LIFT FIRMING SCULPTING FACE AND NECK CREME SPF 15 NML COMBO- octinoxate, octisalate cream 
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 INGREDIENT: 7.5% OCTINOXATE

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)

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 CREME

SPF 15

NORMAL/COMBINATION SKIN



NET WT. 1.7 OZ/ 50 ML




ESTEE LAUDER DISTR
NEW YORK, NY 10022

FOLDING CARTON







RESILIENCE LIFT  FIRMING SCULPTING FACE AND NECK CREME SPF 15 NML COMBO
octinoxate, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11559-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11559-011-011 in 1 CARTON
1NDC:11559-011-0250 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/2011
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: 4/2011
Document Id: 61256a00-2974-4f15-977f-47cc7aafb4f7
Set id: 863d85d8-3996-40c3-af9f-ea84ef22bfb3
Version: 1
Effective Time: 20110419
 
ESTEE LAUDER INC