TIME ZONE

Manufacturer
ESTEE LAUDER INC | ESTEE LAUDER COSMETICS, LTD | ESTEE LAUDER N.V. | Len-Ron Manufacturing Division of Aramis Inc. | Aramis Inc. | Northtec Bristol | Northtec Keystone | Estee Lauder Pennsylvania Distribution Center 2 | Estee Lauder Cosmetics, Ltd. | Estee Lauder Cosmetics Distribution Center | Estee Lauder Kabushiki Kaisha | Whitman Laboratories Ltd. | Aveda Corporation
Effective date
2011-07-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:28:54

Label at a glance#

ProductTIME ZONE LINE AND WRINKLE REDUCING CREME SPF 15 FOR DRY SKIN
Active ingredientOCTISALATE, AVOBENZONE
Label structure5 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS: OCTISALATE 5.00% [] AVOBENZONE 3.00%

INACTIVE INGREDIENT SECTION

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

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


KEEP OUT OF REACH OF CHILDREN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


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
folding carton

 

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11559-728-012020-01-31C16284748780-19d75b9d0-afa8-f424-e053-dadaa90a57ce5618c08e-2e0c-4352-a3dc-ebc1e1c6e2e5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11559-728-01TIME ZONELINE AND WRINKLE REDUCING CREME SPF 15 FOR DRY SKIN1 in 1 CARTONCREAM11
11559-728-02TIME ZONELINE AND WRINKLE REDUCING CREME SPF 15 FOR DRY SKIN50 mL in 1 JARCREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11559-728TIME ZONE LINE AND WRINKLE REDUCING CREME SPF 15 FOR DRY SKIN (OCTSALATE, AVOBENZONE) CREAM [ESTEE LAUDER INC]1Legacy NDC, 2 package rows20110726_5618c08e-2e0c-4352-a3dc-ebc1e1c6e2e5.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
OCTISALATEACTIVE MOIETY4X49Y0596W1
BARLEYINACTIVE INGREDIENT5PWM7YLI7R1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U1
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27E1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
CHOLESTEROLINACTIVE INGREDIENT97C5T2UQ7J1
CREATINEINACTIVE INGREDIENTMU72812GK01
CUCUMBERINACTIVE INGREDIENTYY7C30VXJT1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR71
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH1
LINOLEIC ACIDINACTIVE INGREDIENT9KJL21T0QJ1
MICAINACTIVE INGREDIENTV8A1AW08801
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1E1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYAMINOPROPYL BIGUANIDEINACTIVE INGREDIENT322U039GMF1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4M1
SACCHARINA LATISSIMA WHOLEINACTIVE INGREDIENTRTR3OGP8ET1
SACCHAROMYCES LYSATEINACTIVE INGREDIENTR85W246Z1C1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
TAMARIND SEEDINACTIVE INGREDIENT6AHP8A7OML1
TREHALOSEINACTIVE INGREDIENTB8WCK70T7I1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11559-72811559-728-02, 11559-728-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 310 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET / ORAL33.34 mgExact identifier — unii candidate
21 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLOTION / TOPICAL22 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TAMPON / VAGINALNAExact identifier — unii candidate
49 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / VAGINAL8 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / INTRA-ARTICULAR1 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / VAGINAL0.75 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, FILM COATED / ORAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE PARTICLES / ORAL170 mgExact identifier — unii candidate
49 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TRANSDERMAL8.12 mgExact identifier — unii candidate
2 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ELOTION / TOPICAL300 mgExact identifier — unii candidate
9 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, ORALLY DISINTEGRATING / ORAL9 mgExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYRUP / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7TABLET, EXTENDED RELEASE / ORAL0.64 mgExact identifier — unii candidate
18 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / SOFT TISSUE0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, CHEWABLE / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRALESIONAL0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSPRAY / RESPIRATORY (INHALATION)0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KPOWDER, FOR SUSPENSION / ORAL285 mgExact identifier — unii candidate
77 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii candidate
20 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION/ DROPS / OPHTHALMIC0.13 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL / TOPICAL1.16 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE / ORAL300 mgExact identifier — unii candidate
49 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MAEROSOL, FOAM / TOPICAL30 mgExact identifier — unii candidate
13 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SUSPENSION, EXTENDED RELEASE / ORAL70 mgExact identifier — unii candidate
49 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ELOTION / TOPICAL32468 mgExact identifier — unii candidate
5 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET / ORALNAExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
CHOLESTEROLCHOLESTEROL97C5T2UQ7JLOTION / TOPICAL20 mgExact identifier — unii candidate
10 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SUSPENSION / ORAL400 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7TAPE / TOPICALNAExact identifier — unii candidate
18 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, FILM COATED, EXTENDED RELEASE / ORAL59 mgExact identifier — unii candidate
20 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / ORAL432 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / RECTAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE / ORAL1190 mgExact identifier — unii candidate
49 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7GEL / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4AEROSOL, FOAM / VAGINAL3 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / INTRAVENOUS0.03 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / NASAL100 mg/100mlExact identifier — unii candidate
77 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ad2d5eca-9665-4aec-868a-ab06408436225618c08e-2e0c-4352-a3dc-ebc1e1c6e2e52011-07-22WarningsExact identifier
spl id: ad2d5eca-9665-4aec-868a-ab0640843622
spl set id: 5618c08e-2e0c-4352-a3dc-ebc1e1c6e2e5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.