FDA.reportPublic FDA data

Mary Kay Foundation Primer

Product NDC
51531-0850
11-digit product format
515310850
Labeler code
51531
Product ID
51531-0850_297c8c3c-d5db-d017-e063-6294a90a65ce
Type
HUMAN OTC DRUG
Nonproprietary name
avobenzone, homosalate, octisalate, octocrylene
Dosage form
GEL
Route
TOPICAL
Labeler
Mary Kay Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-03-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
2.5; 9; 5; 3 g/100mL; g/100mL; g/100mL; g/100mL
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 Foundation Primer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE2.5 g/100mL
HOMOSALATE9 g/100mL
OCTISALATE5 g/100mL
OCTOCRYLENE3 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
59d25b44-1adb-4790-8ce6-2d847a06b8b3Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51531-0850-02020-07-22C16284748780-1ab0e2407-3638-f274-e053-dbdaa90a6471Mary Kay Foundation Primer SPF 15 Drug Facts
51531-0850-12020-07-22C16284748780-1ab0e2407-3638-f274-e053-dbdaa90a6471Mary Kay Foundation Primer SPF 15 Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51531-0850-0Mary Kay Foundation Primer0.5 mL in 1 PACKETGEL0.57
51531-0850-1Mary Kay Foundation Primer1 in 1 CARTONGEL17
51531-0850-1Mary Kay Foundation Primer29 mL in 1 TUBEGEL297

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXMARY KAY FOUNDATION PRIMER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) GEL [MARY KAY INC.]1
HOMOSALATEACTIVE INGREDIENTV06SV4M95SMARY KAY FOUNDATION PRIMER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) GEL [MARY KAY INC.]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WMARY KAY FOUNDATION PRIMER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) GEL [MARY KAY INC.]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMMARY KAY FOUNDATION PRIMER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) GEL [MARY KAY INC.]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXMARY KAY FOUNDATION PRIMER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) GEL [MARY KAY INC.]1
HOMOSALATEACTIVE MOIETYV06SV4M95SMARY KAY FOUNDATION PRIMER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) GEL [MARY KAY INC.]1
OCTISALATEACTIVE MOIETY4X49Y0596WMARY KAY FOUNDATION PRIMER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) GEL [MARY KAY INC.]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMMARY KAY FOUNDATION PRIMER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) GEL [MARY KAY INC.]1
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQMARY KAY FOUNDATION PRIMER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) GEL [MARY KAY INC.]1
DIPROPYLENE GLYCOL DIBENZOATEINACTIVE INGREDIENT6OA5ZDY41OMARY KAY FOUNDATION PRIMER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) GEL [MARY KAY INC.]1
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT)INACTIVE INGREDIENTAG75W62QYUMARY KAY FOUNDATION PRIMER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) GEL [MARY KAY INC.]1
ISODODECANEINACTIVE INGREDIENTA8289P68Y2MARY KAY FOUNDATION PRIMER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) GEL [MARY KAY INC.]1
NEOPENTYL GLYCOL DIHEPTANOATEINACTIVE INGREDIENT5LKW3C543XMARY KAY FOUNDATION PRIMER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) GEL [MARY KAY INC.]1
POLYESTER-7INACTIVE INGREDIENT0841698D2FMARY KAY FOUNDATION PRIMER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) GEL [MARY KAY INC.]1
PPG-15 STEARYL ETHER BENZOATEINACTIVE INGREDIENT80D2J6361MMARY KAY FOUNDATION PRIMER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) GEL [MARY KAY INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MARY KAY FOUNDATION PRIMER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) GEL [MARY KAY INC.]1
TRIBEHENININACTIVE INGREDIENT8OC9U7TQZ0MARY KAY FOUNDATION PRIMER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) GEL [MARY KAY INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51531-0850MARY KAY FOUNDATION PRIMER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) GEL [MARY KAY INC.]7Current NDC, Legacy NDC, 3 package rows20241219_59d25b44-1adb-4790-8ce6-2d847a06b8b3.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 14 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UV RESTORE FACE SERUM SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATECOSMAX USA564b8070-ee59-0c24-e063-6294a90ad9a92026-07-10WarningsExact identifier
application number: M020
COCO-EVE COCONUT MILK BODY SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOSMAX USA564b80c2-16e0-fb5f-e063-6394a90a50d22026-07-10WarningsExact identifier
application number: M020
COCO EVE SUNNY HONEY HIGHLIGHTER BODY SPF 50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONECOSMAX USA564b9b1f-3d5b-4349-e063-6294a90a3b772026-07-10WarningsExact identifier
application number: M020
NORWEX Lip Glaze Broad Spectrum SPF 30 HazelnutZINC OXIDECOSMAX USA564ba912-c44b-4940-e063-6294a90a28fa2026-07-10WarningsExact identifier
application number: M020
MISTINE UV INVISIBLE FACE SHEER SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOSMAX USA564bbb5f-4000-390d-e063-6294a90a408d2026-07-10WarningsExact identifier
application number: M020
PEACH AND LILY SUN COVER MINERAL SUNSCREEN SPF 30ZINC OXIDECOSMAX USA564bb5f9-5ac5-548b-e063-6394a90a84622026-07-10WarningsExact identifier
application number: M020
ILLUSION LUMINOUS GLOW FOUNDATIONAVOBENZONE, HOMOSALATE, AND OCTISALATEKingdom Animalia, LLC DBA Hourglass Cosmeticscf6a7e1a-7bca-439c-808a-80262f095f842026-07-10WarningsExact identifier
application number: M020
Tula Skincare Protect and Glow Daily Facial Sunscreen Gel SPF 30AVOBENZONE, HOMOSALATE, AND OCTISALATEThe Procter & Gamble Manufacturing Company30a063fa-e537-a2c1-e063-6394a90a6a832026-07-09WarningsExact identifier
application number: M020
Olay Complete Lightweight with Sunscreen Broad Spectrum SPF 15 SensitiveOCTINOXATE AND ZINC OXIDEThe Procter & Gamble Manufacturing Company3cb971e1-34f1-ee89-e063-6394a90a52a92026-07-09WarningsExact identifier
application number: M020
Olay Complete Lightweight with Sunscreen Broad Spectrum SPF 30 SensitiveOCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDEThe Procter & Gamble Manufacturing Company3cb9de81-f05e-9697-e063-6394a90a69c52026-07-09WarningsExact identifier
application number: M020
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
application number: M020
Sunny C Sunscreen SPF 50SUNNY C SUNSCREENMIXIK, INC.4ed2a482-6c63-69f5-e063-6394a90ad3ee2026-07-08WarningsExact identifier
application number: M020
Ultra Violette Supreme Screen Broad Spectrum SPF 50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEGrace and Fire USA Inc.24389324-19db-7eb5-e063-6394a90ad7fb2026-07-08WarningsExact identifier
application number: M020
ANEW ULTIMATE DAY MULTI-PERFORMANCECREAM SPF 25 SUNSCREENAVOBENZONE, HOMOSALATE, OCTINOXATE,OXYBENZONECOSMAX USA, CORPORATION562053d4-12bd-976e-e063-6394a90a59de2026-07-08WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
application number: M020
Sun Protection Mineral SPF 30ZINC OXIDEderma ebf6474a7-a21f-49cb-86e6-e5c40dbd34c32026-07-08WarningsExact identifier
application number: M020
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
application number: M020
Bath and Body Works SPF Pink DreamAVOBENZONE,HOMOSALATE,OCTISALATEBath & Body Works, Inc.560785f5-9126-12ba-e063-6294a90ac9462026-07-07WarningsExact identifier
application number: M020
Bath and Body Works SPF Sunkissed BerryAVOBENZONE,HOMOSALATE,OCTISALATEBath & Body Works, Inc.56078698-8655-12bd-e063-6294a90ad34c2026-07-07WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51531-0850-051531085000.5 mL in 1 PACKET (51531-0850-0) 2012-03-010000-00-00YesNoCurrent
51531-0850-1515310850011 TUBE in 1 CARTON (51531-0850-1) / 29 mL in 1 TUBE1 tube2012-03-010000-00-00NoNoCurrent