FDA.reportPublic FDA data

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

Product NDC
51531-0549
11-digit product format
515310549
Labeler code
51531
Product ID
51531-0549_2979fb06-9f81-957e-e063-6294a90aafbf
Type
HUMAN OTC DRUG
Nonproprietary name
avobenzone, homosalate, octisalate, octocrylene, oxybenzone
Dosage form
CREAM
Route
TOPICAL
Labeler
Mary Kay Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-05-16
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength
3; 9; 4.5; 4; 4.5 g/100g; g/100g; g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Mary Kay TimeWise Repair Volu-Firm Day Cream Broad Spectrum SPF 30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 g/100g
HOMOSALATE9 g/100g
OCTISALATE4.5 g/100g
OCTOCRYLENE4 g/100g
OXYBENZONE4.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup
95OOS7VE0YInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5f09503e-c455-4ac2-8d07-e8e66c2daa32Available on FDA.report

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

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 16 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Daily Wear Face Protection Mineral Based Sunscreen SPF 16 - Fair LightZINC OXIDEREJUVA MINERALS INC2abccc86-01d4-e45c-e063-6294a90a7f8b2026-07-02WarningsExact identifier
application number: M020
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
application number: M020
Sunscreen SPF 50AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5%Worthy Promotional Productsf5e2a412-e891-411d-85da-89f38cd61a9b2026-07-02WarningsExact identifier
application number: M020
Bath and Body Works SPF Bronze KissAVOBENZONE,HOMOSALATE,OCTISALATEBath & Body Works, Inc.5606c57b-7fdb-4317-e063-6294a90a996c2026-07-02WarningsExact identifier
application number: M020
Evereden Kids Mineral Sunscreen SPF 30ZINC OXIDEEden Brands Incbba219a4-de83-76fd-e053-2995a90a2d692026-07-01WarningsExact identifier
application number: M020
Kids Mineral Face Cream SPF20ZINC OXIDEEden Brands Incfbfccb0c-e459-3282-e053-6394a90ad95d2026-07-01WarningsExact identifier
application number: M020
Evereden Fluid Silk Mineral Sunscreen PRO SPF50TITANIUM DIOXIDE, ZINC OXIDEEden Brands Inc.2cb7773f-9a05-ad02-e063-6294a90af0242026-07-01WarningsExact identifier
application number: M020
Zinc Oxide 20%SUNSCREEN SPF 50The Beach Roosterc2e57236-f184-4fa8-8fd5-c44cbf2300582026-07-01WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID WATERY SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEISNTREE Inc.557477a2-def8-740b-e063-6294a90ad2872026-06-30WarningsExact identifier
application number: M020
HealthyDerm tallow mineral sunscreen SPF50ZINC OXIDE 25%VIRENTIA LLC557b0b1f-8cd9-735a-e063-6294a90ad60e2026-06-30WarningsExact identifier
application number: M020
OHUI Ultimate Cover CC Cushion Compact 01 Light BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d2f9c54b-ac4e-5141-e053-2a95a90aa2b82026-06-30WarningsExact identifier
application number: M020
Christian Dior Invisible UV Stick Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEParfums Christian Dior8e3840b2-b404-474f-aff7-dec3a64a70a42026-06-29WarningsExact identifier
application number: M020
TOCOBO Blur Finish Sun Cushion Cotton BlueHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEPICTON Co., Ltd.4d6ddee3-9a76-6c9c-e063-6394a90a15292026-06-29WarningsExact identifier
application number: M020
Sun Bum Coconut Lip 30 Sunscreen Lip BalmAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC20d942fa-93de-45a8-e063-6294a90a2b492026-06-29WarningsExact identifier
application number: M020
AVON ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENZINC OXIDETHE AVON COMPANY54f7c1d1-acdb-fd25-e063-6294a90a81732026-06-29WarningsExact identifier
application number: M020
Earth Baby Broad Spectrum SPF 30SUNSCREENEarth Baby, Inc.42556876-74ea-38e6-e054-00144ff8d46c2026-06-28WarningsExact identifier
application number: M020
TOCOBO Cotton Airy Sun StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPICTON CO., Ltd.55364026-c55a-b370-e063-6294a90ae0d12026-06-27WarningsExact identifier
application number: M020
Sun Does Matter Daily Face SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDESundoesmatter Company Inc.553687d8-d4e1-8361-e063-6294a90a24fe2026-06-27WarningsExact identifier
application number: M020
ORLASKIN HYDRATING SUNSCREEN SPF 50OCTOCRYLENE ETHYLHEXYL METHOXYCINNAMATE ETHYLHEXYL SALICYLATE AVOBENZONEGuangzhou Yapheon Health Industry Co., Ltd.552b4c87-4621-d5a7-e063-6294a90a042e2026-06-26WarningsExact identifier
application number: M020
Bath and Body Works SPF Waikiki Beach CoconutAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEBath & Body Works, Inc.1c30de8a-4d29-bbac-e063-6294a90a84d92026-06-26WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51531-0549-3515310549039 g in 1 TUBE (51531-0549-3) 9 g2019-05-160000-00-00NoNoCurrent
51531-0549-7515310549071 JAR in 1 CARTON (51531-0549-7) / 48 g in 1 JAR1 jar2019-05-160000-00-00NoNoCurrent