FDA.reportPublic FDA data

Mary Kay TimeWise Repair Volu-Firm Set

Product NDC
51531-8434
11-digit product format
515318434
Labeler code
51531
Product ID
51531-8434_297ccd9b-dcd0-1eb6-e063-6394a90ad1d9
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
Dosage form
KIT
Labeler
Mary Kay Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-08-16
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 Set
Listing expiration
2026-12-31

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d459e2f7-dc78-4519-9733-01495fc447a2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
0b1603b8-969e-b082-f6f5-ad66d8a6ea8aProduct name220200325
19041f15-771b-3d3a-88fc-f5e2d079cd6dProduct name220200325
1987d950-08e4-4b70-adeb-fb67a71142abProduct name220200325
8825ddf7-1520-4680-b0ee-684e2fa73672Product name220200325
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
267a6f34-90b4-2f48-3063-4f505d06a7beProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51531-8434-0Mary Kay TimeWise Repair Volu-Firm Set1 in 1 CARTONKIT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51531-8434MARY KAY TIMEWISE REPAIR VOLU-FIRM SET (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) KIT [MARY KAY INC.]5Current NDC, Legacy NDC, 1 package rows20241222_d459e2f7-dc78-4519-9733-01495fc447a2.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 19 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Not there spf broad spectrum spf40 moisturizerAVOBENZONE 3% ,HOMOSALATE 10% ,OCTISALATE 5% ,OCTOCRYLENE 8% ,ZINC OXIDE 4%Foshan Sugar Max Cosmetics CO.,Ltd546f0474-4102-26d0-e063-6394a90a388b2026-06-17WarningsExact identifier
application number: M020
Ultra Violette Velvet Screen Blurring Mineral Skinscreen Broad Spectrum SPF 40ZINC OXIDEGrace and Fire USA Inc.52d4b1c1-7431-4f8c-e063-6294a90ad4822026-06-17WarningsExact identifier
application number: M020
EVIL GOODS TALLOW SUNSCREEN SPF30ZINC OXIDEMoes Group LLC54751f23-5723-0407-e063-6294a90a4a962026-06-17WarningsExact identifier
application number: M020
Amber Sunglaze Sheer Body Mist Sunscreen SPF30AVOBENZONE, OCTISALATE, OCTOCRYLENEKoco Life LLC5478fb36-e972-f824-e063-6294a90a567f2026-06-17WarningsExact identifier
application number: M020
Elaine Sterling Hydrating SunscreenZINC OXIDEElaine Sterling Enterprises5479e862-aca5-7541-e063-6394a90ad0c52026-06-17WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Day Cream Sunscreen Broad Spectrum SPF 25AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS545aa56a-ed07-acd6-e063-6394a90ae0c72026-06-16WarningsExact identifier
application number: M020
MAYBELLINE NEW YORK FIT ME DEWY PLUS SMOOTH FOUNDATION SPF 18 SUNSCREENOCTISALATELOreal USA Products Inc3b99ab06-ba4c-4ddd-a057-60028eedd67d2026-06-16WarningsExact identifier
application number: M020
TERRA LOTUS SPF 50 ORGANIC TALLOW SUNSCREENZINCOXIDEMoes Group LLC54617bf2-1d8d-531e-e063-6294a90a70802026-06-16WarningsExact identifier
application number: M020
Daily Defence Mineral Sunscreen SPF 50 Fragrance FreeZINC OXIDEUltraceuticals Pty Ltd5461ee82-0297-ce22-e063-6294a90a729b2026-06-16WarningsExact identifier
application number: M020
GlowBiotics Tinted Sunscreen SPF 30ZINC OXIDERum Brands, LLC544dba29-4785-4ab6-e063-6394a90a17b32026-06-16WarningsExact identifier
application number: M020
Societe Prime and DefendZINC OXIDE SUNSCREENSociete Clinical Skincare5439bd31-5ee1-9bca-e063-6394a90a748c2026-06-16WarningsExact identifier
application number: M020
Societe CoverShield Tinted SPFZINC OXIDESociete Clinical Skincare545efbc4-82d4-f126-e063-6294a90a97102026-06-16WarningsExact identifier
application number: M020
TITAN TALLOW SPF 50 ORGANIC TALLOW SUNSCREENZINC OXIDEMoes Group LLC546b0702-a3cc-fd6f-e063-6394a90af8492026-06-16WarningsExact identifier
application number: M020
365 WHOLE FOODS MARKET MINERAL SPF 30ZINC OXIDEWhole Foods Market, Inc.5ce712d6-cafd-4a80-9f8c-2149fdebff542026-06-16WarningsExact identifier
application number: M020
365 WHOLE FOODS MARKET MINERAL SPF 50ZINC OXIDEWhole Foods Market, Inc.1f8387be-d871-435b-baef-e537c67a510a2026-06-15WarningsExact identifier
application number: M020
365 WHOLE FOODS MARKET SUNSCREEN CLEAR COCONUT VANILLA SPF 50OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND HOMOSALATEWhole Foods Market, Inc.82771f22-0197-40ba-97d2-2386152790ed2026-06-15WarningsExact identifier
application number: M020
365 WHOLE FOODS MARKET SUNSCREEN CLEAR COCONUT VANILLA SPF 30OCTOCRYLENE, OCTISALATE, AND AVOBENZONEWhole Foods Market, Inc.1c31f466-6a0d-46ce-9346-d2a0eb46c8d02026-06-15WarningsExact identifier
application number: M020
Shield by HEALTHY SKIN LAB MD SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEHEALTHY SKIN LAB LIMITED6838b754-9915-48ff-af35-5338dbd06ac42026-06-15WarningsExact identifier
application number: M020
Solvyn Mineral Sunscreen SPF 50ZINC OXIDESolvyn Skin LLCb0a8d028-87d2-4339-8879-c62cbf8415f22026-06-15WarningsExact identifier
application number: M020
Amrit Ocean Resort Mineral Sunscreen SPF 50ZINC OXIDESolvyn Skin, LLC112364cd-a445-46c2-b2f3-f9705d682cf62026-06-15WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51531-8434-0515318434001 KIT in 1 CARTON (51531-8434-0) * 29 mL in 1 BOTTLE, GLASS * 127 g in 1 TUBE * 48 g in 1 JAR * 14 g in 1 TUBE, WITH APPLICATOR * 48 g in 1 JAR1 kit2019-08-160000-00-00NoNoCurrent