TIME ZONE LINE AND WRINKLE REDUCING CREME SPF 15 NORMAL COMBO SKIN- octinoxate, octsalate, avobenzone 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 INGREDIENTS: OCTINOXATE 7.50% [] OCTISALATE 5.00% [] AVOBENZONE 3.00%

INACTIVE INGREDIENTS: WATER [] BUTYLENE GLYCOL [] OCTYLDODECYL MYRISTATE [] GLYCERIN [] NEOPENTYL GLYCOL DIHEPTANOATE [] DIMETHICONE [] CETYL ALCOHOL [] PENTYLENE GLYCOL [] GLYCERYL STEARATE [] BEHENYL ALCOHOL [] YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE [] PUNICA GRANATUM (POMEGRANATE) JUICE EXTRACT [] CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT [] HUMULUS LUPULUS (HOPS) EXTRACT [] SELAGINELLA TAMARISCINA (SPIKE MOSS) EXTRACT [] POLYGONUM CUSPIDATUM ROOT EXTRACT [] VITIS VINIFERA (GRAPE) SEED EXTRACT [] ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT [] CITRUS RETICULATA (TANGERINE) PEEL EXTRACT [] OLEA EUROPAEA (OLIVE) FRUIT EXTRACT [] TRITICUM VULGARE (WHEAT BRAN) EXTRACT [] HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE [] TAMARINDUS INDICA SEED EXTRACT [] ARGANIA SPINOSA LEAF EXTRACT [] LAMINARIA SACCHARINA EXTRACT [] LARIX SIBIRICA WOOD EXTRACT [] CENTAURIUM ERYTHRAEA (CENTAURY) EXTRACT [] PADINA PAVONICA THALLUS EXTRACT [] HYDROLYZED RICE EXTRACT [] CAPRYLIC/CAPRIC/MYRISTIC/STEARIC TRIGLYCERIDE [] SIGESBECKIA ORIENTALIS EXTRACT [] CHOLESTEROL [] POLYETHYLENE [] PENTAERYTHRITYL TETRAETHYLHEXANOATE [] CAFFEINE [] LINOLEIC ACID [] HYDROGENATED LECITHIN [] LINOLENIC ACID [] PEG-100 STEARATE [] PHYTANTRIOL [] TREHALOSE [] PVP/HEXADECENE COPOLYMER [] ACETYL GLUCOSAMINE [] CREATINE [] HDI/PPG/POLYCAPROLACTONE CROSSPOLYMER [] CAPRYLYL GLYCOL [] ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER [] POLYSILICONE-11 [] HYALURONIC ACID [] ISOHEXADECANE [] ACETYL HEXAPEPTIDE-8 [] PROPYLENE GLYCOL DICAPRATE [] SODIUM PCA [] ADENOSINE PHOSPHATE [] HELIANTHUS ANNUUS (SUNFLOWER) SEEDCAKE [] POLYSORBATE 80 [] SODIUM HYALURONATE [] SILICA [] HEXYLENE GLYCOL [] NORDIHYDROGUAIARETIC ACID [] CYCLODEXTRIN [] POTASSIUM CARBOMER [] CARBOMER [] FRAGRANCE (PARFUM) [] ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE [] DISODIUM EDTA [] PHENOXYETHANOL

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


KEEP OUT OF REACH OF CHILDREN


PRINCIPAL DISPLAY PANEL:


ESTEE LAUDER

TIME ZONE

LINE AND WRINKLE REDUCING CREAM

SPF 15

NORMAL/COMBINATION SKIN



1.7 OZ/ 50 ML



ESTEE LAUDER DISTR.
NY, NY 10022


folding carton


TIME ZONE  LINE AND WRINKLE REDUCING CREME SPF 15 NORMAL COMBO SKIN
octinoxate, octsalate, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11559-737
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) OCTISALATE5.0 mL  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
CUCUMBER (UNII: YY7C30VXJT)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
BARLEY (UNII: 5PWM7YLI7R)  
TAMARIND SEED (UNII: 6AHP8A7OML)  
SACCHARINA LATISSIMA WHOLE (UNII: RTR3OGP8ET)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
LINOLEIC ACID (UNII: 9KJL21T0QJ)  
TREHALOSE (UNII: B8WCK70T7I)  
CREATINE (UNII: MU72812GK0)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11559-737-011 in 1 CARTON
1NDC:11559-737-0250 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/01/2009
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: c1f40cf7-0c05-4f20-b8a7-63056e305da7
Set id: 4f6a335a-c6df-4076-b6b5-371ecb03be29
Version: 1
Effective Time: 20110722
 
ESTEE LAUDER INC