TIME ZONE LINE AND WRINKLE REDUCING CREME SPF 15 FOR DRY SKIN- 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: OCTISALATE 5.00% [] AVOBENZONE 3.00%

INGREDIENTS: WATER\AQUA\EAU [] DIMETHICONE [] BUTYROSPERMUM PARKII (SHEA BUTTER) [] POLYESTER-8 [] BUTYLENE GLYCOL [] DI-C12-15 ALKYL FUMARATE [] STEARETH-21 [] PENTAERYTHRITYL TETRAETHYLHEXANOATE [] SUCROSE [] CETYL ALCOHOL [] NEOPENTYL GLYCOL DIETHYLHEXANOATE [] HDI/PPG/POLYCAPROLACTONE CROSSPOLYMER [] GLYCERIN [] STEARETH-2 [] ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER [] CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT [] ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT [] SELAGINELLA TAMARISCINA (SPIKE MOSS) EXTRACT [] CITRUS RETICULATA (TANGERINE) PEEL EXTRACT [] HUMULUS LUPULUS (HOPS) EXTRACT [] YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE [] TRITICUM VULGARE (WHEAT BRAN) EXTRACT [] HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE [] TAMARINDUS INDICA SEED EXTRACT [] ARGANIA SPINOSA LEAF EXTRACT [] HYDROLYZED RICE EXTRACT [] PADINA PAVONICA THALLUS EXTRACT [] LARIX SIBIRICA WOOD EXTRACT [] POLYGONUM CUSPIDATUM ROOT EXTRACT [] VITIS VINIFERA (GRAPE) SEED EXTRACT [] SIGESBECKIA ORIENTALIS (ST. PAUL'S WORT) EXTRACT [] PUNICA GRANATUM (POMEGRANATE) JUICE EXTRACT [] OLEA EUROPAEA (OLIVE) FRUIT EXTRACT [] CENTAURIUM ERYTHRAEA (CENTAURY) EXTRACT [] LAMINARIA SACCHARINA EXTRACT [] CHOLESTEROL [] CREATINE [] ADENOSINE PHOSPHATE [] HELIANTHUS ANNUUS (SUNFLOWER) SEEDCAKE [] CAFFEINE [] POLYETHYLENE [] PVP/HEXADECENE COPOLYMER [] CETYL DIMETHICONE [] ISOHEXADECANE [] DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE [] PPG-15 STEARYL ETHER [] POLYSILICONE-11 [] TOCOPHERYL ACETATE [] LINOLENIC ACID [] PHYTANTRIOL [] SODIUM HYALURONATE [] TREHALOSE [] ACETYL GLUCOSAMINE [] HYALURONIC ACID [] ETHYLHEXYLGLYCERIN [] ACETYL HEXAPEPTIDE-8 [] CAPRYLYL GLYCOL [] PROPYLENE GLYCOL DICAPRATE [] SODIUM PCA [] PROPYLENE GLYCOL HEPTANOATE [] POLYSORBATE 80 [] CYCLODEXTRIN [] LINOLEIC ACID [] ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER [] NEOPENTYL GLYCOL DIISOSTEARATE [] TROMETHAMINE [] HEXYLENE GLYCOL [] SILICA [] FRAGRANCE (PARFUM) [] NORDIHYDROGUAIARETIC ACID [] ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE [] DISODIUM EDTA [] PHENOXYETHANOL [] POLYAMINOPROPYL BIGUANIDE [] MICA

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

DRY SKIN



1.7 OZ/ 50 ML



ESTEE LAUDER DISTR.
NY, NY 10022

folding carton

 
TIME ZONE  LINE AND WRINKLE REDUCING CREME SPF 15 FOR DRY SKIN
octsalate, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11559-728
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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
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)  
MICA (UNII: V8A1AW0880)  
POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11559-728-011 in 1 CARTON
1NDC:11559-728-0250 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: ad2d5eca-9665-4aec-868a-ab0640843622
Set id: 5618c08e-2e0c-4352-a3dc-ebc1e1c6e2e5
Version: 1
Effective Time: 20110722
 
ESTEE LAUDER INC