FDA.reportPublic FDA data

Timewise Day Solution sunscreen SPF 35

Manufacturer
Mary Kay Inc.
Effective date
2012-03-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:31:04

Label at a glance#

ProductTimewise Day Solution sunscreen SPF 35
Active ingredientOxybenzone, Avobenzone, Octisalate, Homosalate, OCTOCRYLENE
Label structure6 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION


Active Ingredients ; HOMOSALATE (10% w/w) ,OCTISALATE(5% w/w),OXYBENZONE(4%w/w), OCOCRYLENE (2% w/w), AVOBENZONE(2% w/w)

WARNINGS SECTION


Warnings; For external use only. Not to be swalloed. Avoid contact with the eyes. Discontinue use if signs of irritation or rash appear.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. Do not stay too long in the sun, even while using a sunscreen product.

INDICATIONS & USAGE SECTION

Indication; Broad-spectrum UVA/UVB protection.

INACTIVE INGREDIENT SECTION

Water,Dimethicone, Butylene Glycol,Styrene/Acrylates Copolymer,C12-15 Alkyl Benzoate,Dicapryl Carbonate,Glycerin,Ceteareth-25,Dimethicone Crosspolymer,Magnesium Aluminum Silicate, Acetyl Dipeptide-1,Cetyl Ester, Plankton Extract,Hydrolyzed Algin, Adenosin, Pentylene Glycol , Tocopheryl Acetate,Crithmum Marithimum Extract,Ascorbic Acid,Hydrogenated Lecithin,Hydroxyethylcellulose,Dipropylene Glycol,Dibenzoate Acrylate / C12-22 Alkyl Methacrylate Crosspolymer ,Disodium Ethylene Dicocamide PEG-15 Disulfate,Sorbic Acid ,Caprylyl Glycol, PPG-15 Stearyl Ether Benzoate,Propylene Glycol , Xanthan Gum, Cyclopentasiloxane, PEG-75,PEG-150,PEG-6 Cetyl Dimethicone,PEG-4 Laurate,Laureth-3 ,Disodium EDTA , Ammonium Hydroxide,Iodopropyl Butylcarbamate,Methylparaben,Phenoxyethanol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

 IMAGE OF CARTONIMAGE OF CARTON

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51531-8363-02020-01-31C16284748780-19d75b9d0-1447-f424-e053-dadaa90a57ce604f72ee-ba5a-4d36-9e29-bb78e4977e0c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51531-8363-0Timewise Day Solution sunscreen SPF 3529 mL in 1 BOTTLE, DISPENSINGCREAM291

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51531-8363TIMEWISE DAY SOLUTION SUNSCREEN SPF 35 (HOMOSALATE,OCTISALATE,OXYBENZONE,OCTOCRYLENE,AVOBENZONE ) CREAM [MARY KAY INC.]1Legacy NDC, 1 package rows20120305_604f72ee-ba5a-4d36-9e29-bb78e4977e0c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOX1
HomosalateACTIVE INGREDIENTV06SV4M95S1
OctisalateACTIVE INGREDIENT4X49Y0596W1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM1
OxybenzoneACTIVE INGREDIENT95OOS7VE0Y1
AvobenzoneACTIVE MOIETYG63QQF2NOX1
HomosalateACTIVE MOIETYV06SV4M95S1
OctisalateACTIVE MOIETY4X49Y0596W1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM1
OxybenzoneACTIVE MOIETY95OOS7VE0Y1
Butylene GlycolINACTIVE INGREDIENT3XUS85K0RA1
C12-15 Alkyl BenzoateINACTIVE INGREDIENTA9EJ3J61HQ1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51531-836351531-8363-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
Oxybenzone95OOS7VE0YACTIB
AvobenzoneG63QQF2NOXACTIB
Octisalate4X49Y0596WACTIB
HomosalateV06SV4M95SACTIB
Water059QF0KO0RIACT
Butylene Glycol3XUS85K0RAIACT
C12-15 Alkyl BenzoateA9EJ3J61HQIACT
OCTOCRYLENE5A68WGF6WMACTIB

Source Document#

Source XML · Source PDF

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 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Butylene GlycolBUTYLENE GLYCOL3XUS85K0RASYSTEM / TRANSDERMAL8.12 mgExact identifier — unii candidate
2 equally ranked IID candidates
Butylene GlycolBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 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
ab14546e-9ffa-415d-9899-f2d60184b7f7604f72ee-ba5a-4d36-9e29-bb78e4977e0c2012-03-01WarningsExact identifier
spl id: ab14546e-9ffa-415d-9899-f2d60184b7f7
spl set id: 604f72ee-ba5a-4d36-9e29-bb78e4977e0c

Reported adverse events (FAERS/openFDA)#

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