TIME ZONE LINE AND WRINKLE REDUCING CREME SPF 15 FOR DRY SKIN

Dosage form: cream
Ingredients: OCTISALATE 5.0mL in 100mL, AVOBENZONE 3.0mL in 100mL
Labeler: ESTEE LAUDER INC
NDC Code: 11559-728

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.

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


 
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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (OCTISALATE) OCTISALATE5.0 mL  in 100 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE3.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL 
GLYCERIN 
DIMETHICONE 
CETYL ALCOHOL 
GLYCERYL MONOSTEARATE 
SACCHAROMYCES LYSATE 
CUCUMBER 
OLIVE OIL 
BARLEY 
TAMARIND SEED 
SACCHARINA LATISSIMA WHOLE 
CHOLESTEROL 
HIGH DENSITY POLYETHYLENE 
LINOLEIC ACID 
TREHALOSE 
CREATINE 
CAPRYLYL GLYCOL 
POLYSORBATE 60 
HYALURONATE SODIUM 
SILICON DIOXIDE 
CARBOMER HOMOPOLYMER TYPE C 
EDETATE DISODIUM 
PHENOXYETHANOL 
MICA 
POLYAMINOPROPYL BIGUANIDE 
Packaging
#Item CodePackage Description
1NDC:11559-728-011 JAR (JAR) 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/FEIOperations
ESTEE LAUDER COSMETICS, LTD205952385manufacture
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER N.V.370151326manufacture
Establishment
NameAddressID/FEIOperations
Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
Establishment
NameAddressID/FEIOperations
Aramis Inc.042918826manufacture
Establishment
NameAddressID/FEIOperations
Northtec Bristol949264774manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Northtec Keystone618107429manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics, Ltd.255175580manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics, Ltd253616536manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics Distribution Center208579636repack, relabel
Establishment
NameAddressID/FEIOperations
Estee Lauder Kabushiki Kaisha712808195relabel, repack
Establishment
NameAddressID/FEIOperations
Whitman Laboratories Ltd.216866277manufacture
Establishment
NameAddressID/FEIOperations
Aveda Corporation071352058manufacture

Revised: 07/2011
 
ESTEE LAUDER INC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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