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 55 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EWC Slow Lightweight Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEEWC Ventures, LLC063426b8-d1cf-4ee2-8ab8-ff007227eab82026-03-10WarningsExact identifier
application number: M020
Olay Vitamin C Brightening Facial Moisturizer with Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company4cb268ea-f2b5-ddd1-e063-6394a90a1e962026-03-10WarningsExact identifier
application number: M020
Vacation Grand Cuvee Shimmer SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation INC.e0b3d90b-ba56-43e5-aa68-8e5f473628ff2026-03-09WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique ANTHELIOS UVPRO SPORT INVISIBLE SUNSCREEN BROAD SPECTRUM SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA, Inc.77f46325-600c-40ff-94fc-ea82d43134c22026-03-09WarningsExact identifier
application number: M020
Civant 50 Sunscreen Broad Spectrum SPF 50OCTOCRYLENE, ZINC OXIDECivant LLCe23622b8-49dd-45b9-8c51-1a83181cc7bd2026-03-09WarningsExact identifier
application number: M020
HydroScreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEMETHODIQ INC.4c9d5dfd-d790-fffc-e063-6294a90a4d302026-03-09WarningsExact identifier
application number: M020
Sunsei SPF 45 SunscreenZINC OXIDEShimoda Prime Products, LLC3d48e3e2-18c7-e004-e063-6294a90af4f22026-03-09WarningsExact identifier
application number: M020
Sunsei SPF 30 SunscreenZINC OXIDEShimoda Prime Products, LLC68df620b-7c1c-448c-93fd-91459e393c642026-03-09WarningsExact identifier
application number: M020
EADEM SUNSUEDE DAILY SUNSCREEN AND BLURRING PRIMER SPF50 PLUSAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEADEM, Inc.4ca05e2f-f0c5-821c-e063-6294a90a90b82026-03-09WarningsExact identifier
application number: M020
COOLA SunBlur Primer SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC4c6439e8-abda-663a-e063-6394a90ac43b2026-03-06WarningsExact identifier
application number: M020
COOLA SunBlur Makeup Mist SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC4c666a82-293e-06df-e063-6294a90ad5512026-03-06WarningsExact identifier
application number: M020
No 7 Restore and Renew Multi Action Fragrance Free Day Cream SPF 25AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS4d6d1fda-da78-62ed-e063-6294a90ac1052026-03-06WarningsExact identifier
application number: M020
Palio Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATESole Palio LLC071d5113-8fe8-44bb-8322-542eafc2800a2026-03-05WarningsExact identifier
application number: M020
Olay Age Defying Classic Broad Spectrum SPF 15OCTINOXATE AND ZINC OXIDEThe Procter & Gamble Manufacturing Company4c49dbf1-d1fe-ad4a-e063-6394a90af1512026-03-05WarningsExact identifier
application number: M020
SPF 70 Kids SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDerma Care Research Labs, LLC0aadc378-dc34-9a37-e063-6294a90ad49e2026-03-05WarningsExact identifier
application number: M020
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL B50OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION4490f968-46b6-44d2-af2d-5130b52c88612026-03-05WarningsExact identifier
application number: M020
Sunscreen SPF 50SUNSCREEN SPF 50Guangzhou Ariel Biotech Co., Ltd.14b9ec0e-6fff-44b1-e063-6394a90aab972026-03-05WarningsExact identifier
application number: M020
belif Aqua bomb - glow sunstick SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H CO., LTD.4c35fbbc-a79d-318f-e063-6394a90a30a72026-03-04WarningsExact identifier
application number: M020
Kids Mineral Sunscreen Stick SPF 50ZINC OXIDESmalls Brand LLC DBA Roe Wellness4c37855b-08c0-0aa7-e063-6394a90a88422026-03-04WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Toleriane Double Repair Moisturizer UV Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Incbe03b588-afbd-41d1-be96-444d735c97682026-03-03WarningsExact 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