FDA.reportPublic FDA data

Mary Kay TimeWise Repair Volu-Firm Day Cream Broad Spectrum SPF 30

Manufacturer
Mary Kay Inc. | Englewood Lab Inc.
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:44:13

Label at a glance#

ProductMary Kay TimeWise Repair Volu-Firm Day Cream Broad Spectrum SPF 30
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Label structure9 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

apply liberally 15 minutes before sun exposure      use a water-resistant sunscreen if swimming or sweating      reapply at least every 2 hours Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:      limit time in the sun, es...

Storage and handling

protect this product from excessive heat and direct sun. Store above 32° F / 0° C.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 9%

Octisalate 4.5%

Octocrylene 4%

Oxybenzone 4.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  •      use a water-resistant sunscreen if swimming or sweating
  •      reapply at least every 2 hours
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  •      limit time in the sun, especially from 10 a.m. - 2 p.m.
  •      wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, butylene glycol, glycerin, cetearyl alcohol, behenyl alcohol, dicaprylyl carbonate, ammonium acryloyldimethyltaurate/VP copolymer, dimethicone, ceteareth-25, pentylene glycol, tripeptide-1, tocopheryl acetate, hexylresorcinol, sodium PCA, centella asiatica meristem cell culture, silybum marianum fruit extract, cestrum latifolium leaf extract, calcium ketogluconate, 4-t-butylcyclohexanol, disodium ethylene dicocamide PEG-15 disulfate, bisabolol, xanthan gum, methyldihydrojasmonate, ethylene brassylate, ethyl linalool, disodium EDTA, trimethylbenzenepropanol, isobutyl methyl tetrahydropyranol, gamma-undecalactone, phenylisohexanol, sodium benzoate, tetradecyl aminobutyroylvalylaminobutyric urea trifuoroacetate, silica, triethanolamine, citric acid, propanediol, caprylyl glycol, decylene glycol, hydroxypropyl cyclodextrin, phenoxyethanol, hexylene glycol, ethylhexylglycerin, 1,2-hexanediol, magnesium chloride, iodopropynyl butylcarbamate

Other information

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun. Store above 32° F / 0° C.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-627-9529

Principal Display Panel - 48 g carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mary Kay

timewise repair

volu-firm day cream

sunscreen

broad spectrum

spf 30

1.7 OZ. NET WT. / 48 g

image of cartonimage of carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51531-0549-32020-07-22C16284748780-1ab0e2407-2786-f274-e053-dbdaa90a6471Mary Kay TimeWise Repair VoluFirm Day Cream SPF 30 (2018 update) Drug Facts
51531-0549-72020-07-22C16284748780-1ab0e2407-2786-f274-e053-dbdaa90a6471Mary Kay TimeWise Repair VoluFirm Day Cream SPF 30 (2018 update) Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51531-0549-3Mary Kay TimeWise Repair Volu-Firm Day Cream Broad Spectrum SPF 309 g in 1 TUBECREAM97
51531-0549-7Mary Kay TimeWise Repair Volu-Firm Day Cream Broad Spectrum SPF 301 in 1 CARTONCREAM17
51531-0549-7Mary Kay TimeWise Repair Volu-Firm Day Cream Broad Spectrum SPF 3048 g in 1 JARCREAM487

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51531-0549MARY KAY TIMEWISE REPAIR VOLU-FIRM DAY CREAM BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MARY KAY INC.]7Current NDC, Legacy NDC, 3 package rows20241219_5f09503e-c455-4ac2-8d07-e8e66c2daa32.zip

Products#

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

DailyMed product names page 1 of 2 · 52 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51531-054951531-0549-7, 51531-0549-3

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 50 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
GLYCERINPDC6A3C0OXIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DOCOSANOL9G1OE216XYIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
DIMETHICONE92RU3N3Y1OIACT
CETEARETH-258FA93U5T67IACT
PENTYLENE GLYCOL50C1307PZGIACT
PHENOXYETHANOLHIE492ZZ3TIACT
METHYL DIHYDROJASMONATE (SYNTHETIC)3GW44CIE3YIACT
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATEQI9A6U005WIACT
CALCIUM 2-KETOGLUCONATE8K5SM7SI6YIACT
HEXYLRESORCINOLR9QTB5E82NIACT
4-TERT-BUTYLCYCLOHEXANOLK0H1405S9CIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ETHYLENE BRASSYLATE9A87HC7RODIACT
CAPRYLYL GLYCOL00YIU5438UIACT
EDETATE DISODIUM7FLD91C86KIACT
ETHYL LINALOOLSF2JS9GF5TIACT
TROLAMINE9O3K93S3TKIACT
LEVOMENOL24WE03BX2TIACT
DECYLENE GLYCOLS57M60MI88IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
HYDROXYPROPYL .ALPHA.-CYCLODEXTRINZFR0T80O4YIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CENTELLA ASIATICA7M867G6T1UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
TRIMETHYLBENZENEPROPANOL7S411YY2VYIACT
2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OLVK5ZHH2T3FIACT
MILK THISTLEU946SH95EEIACT
.GAMMA.-UNDECALACTONEQB1T0AG2YLIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
PHENYLISOHEXANOLM56178H183IACT
PROPANEDIOL5965N8W85TIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
CESTRUM LATIFOLIUM LEAFO2618B6E88IACT

Source Document#

Source XML

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
Mary Kay TimeWise Repair Volu-Firm Day Cream Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEMary Kay Inc.5f09503e-c455-4ac2-8d07-e8e66c2daa322024-12-17WarningsExact identifier
ndc (package): 51531-0549-7
ndc (package): 51531-0549-3
ndc (product): 51531-0549
ndc11 (package): 51531054903
ndc11 (package): 51531054907
spl id: 2979fb06-9f81-957e-e063-6294a90aafbf
spl set id: 5f09503e-c455-4ac2-8d07-e8e66c2daa32

Reported adverse events (FAERS/openFDA)#

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