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 9 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Continuous Correction CreamHOMOSALATE 10% OCTISALATE 4.9% OCTOCRYLENE 4%Baxter of California, LLC14b05c8c-0398-2973-e063-6394a90a8a862026-07-31WarningsExact identifier
application number: M020
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
application number: M020
MELAO GHK-Cu PEPTIDE SUNSCREENBUTYL METHOXYDIBENZOYLMETHANE,ETHYLHEXYL SALICYLATE,HOMOSALATE,OCTOCRYLENEGuangdong Aimu Biological Technology Co., Ltd57a8c34a-d6c9-c03e-e063-6394a90a7af12026-07-29WarningsExact identifier
application number: M020
BelleJoss BROAD SPECTRUM SPF 50BROAD SPECTRUM SPF 50Guangzhou Liyan Cosmetics Technology Co., Ltd.57c07f29-2e23-d18a-e063-6394a90a10202026-07-29WarningsExact identifier
application number: M020
BemeJolie BROAD SPECTRUM SPF 50BROAD SPECTRUM SPF 50Guangzhou Liyan Cosmetics Technology Co., Ltd.57c27cea-bb0c-5d2d-e063-6394a90a1b482026-07-29WarningsExact identifier
application number: M020
DeFlameALLANTOINNoon Aesthetics M.R. Ltd2628bd73-0ca9-497b-bcd9-088444cd62be2026-07-28WarningsExact identifier
application number: M020
Native Mineral Suncare Broad Spectrum SPF 30 UnscentedZINC OXIDEThe Procter & Gamble Manufacturing Company3a89238b-d1ee-d7fa-e063-6294a90ae55f2026-07-28WarningsExact identifier
application number: M020
First Aid Beauty FAB Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Companydfb1b42e-c821-1a41-e053-2995a90acf952026-07-28WarningsExact identifier
application number: M020
HEB 50 Pumpkin Spice Latte Scent SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B.579f3274-398e-7eab-e063-6394a90afe352026-07-27WarningsExact identifier
application number: M020
LUXE COLOR FOUNDATIONOCTINOXATE 7% ZINC OXIDE 5%Guangzhou Huixue Biotechnology Co., Ltd.576c3496-702f-808c-e063-6394a90a53c32026-07-25WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Day Cream Sunscreen Broad Spectrum SPF 25 KitAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEXact Packing Limited5759058d-e683-f3fc-e063-6394a90abc012026-07-24WarningsExact identifier
application number: M020
No7 Future Renew Defense Shield SPF 50AVOBENZONE, OCTINOXATE, OCTISALATEXact Packing Limited5758b79f-6386-bbea-e063-6394a90aeb342026-07-24WarningsExact identifier
application number: M020
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
application number: M020
SERVE AND PRIME SUNSCREEN BROAD SPECTRUM SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEESTEE LAUDER INC575fc04a-794a-93e7-e063-6394a90a7e672026-07-24WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 LIGHTZINC OXIDEYounique, LLCf93d42a9-b655-4b75-a16d-b29f38f04efc2026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 LIGHT MEDIUMZINC OXIDEYounique, LLC82769819-b229-4864-9b3c-44f49a68a53a2026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 FAIRZINC OXIDEYounique, LLCed700cae-8226-48d9-93ba-03154aa1cae52026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 FAIR LIGHTZINC OXIDEYounique, LLCd728b89c-692f-485b-88c3-929b2f0350d52026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 MEDIUMZINC OXIDEYounique, LLCa49dfff1-e9ec-4573-90b0-ef6a7226aa562026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 MEDIUM DARKZINC OXIDEYounique, LLCcc576b63-caf4-491d-8d7f-027b1127133b2026-07-23WarningsExact 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