FDA.reportPublic FDA data

Mary Kay Foundation Primer

Manufacturer
Mary Kay Inc.
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:44:12

Label at a glance#

ProductMary Kay Foundation Primer
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure9 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

apply liberally 15 minutes before sun exposure use a water-resistant sunscreen if swimming or sweating reapply at least every 2 hours Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 1...

Storage and handling

protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.5%

Homosalate 9%

Octisalate 5%

Octocrylene 3%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • use a water-resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

isododecane, dimethicone/bis-isobutyl PPG-20 crosspolymer, polysilicone-11, vp/hexadecene copolymer, silica, C12-15 alkyl benzoate, polyester-7, neopentyl glycol diheptanoate, tribehenin, dipropylene glycol dibenzoate, PPG-15 stearyl ether benzoate

Other information

STORAGE AND HANDLING SECTION

protect this product from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-627-9529

Principal Display Panel - 29 mL carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mary Kay

foundation primer

sunscreen

broad spectrum

spf 15

1 FL. OZ. / 29 mL

image of foundation primer cartonimage of foundation primer carton

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 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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
HOMOSALATEACTIVE INGREDIENTV06SV4M95S1
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
HOMOSALATEACTIVE MOIETYV06SV4M95S1
OCTISALATEACTIVE MOIETY4X49Y0596W1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM1
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ1
DIPROPYLENE GLYCOL DIBENZOATEINACTIVE INGREDIENT6OA5ZDY41O1
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT)INACTIVE INGREDIENTAG75W62QYU1
ISODODECANEINACTIVE INGREDIENTA8289P68Y21
NEOPENTYL GLYCOL DIHEPTANOATEINACTIVE INGREDIENT5LKW3C543X1
POLYESTER-7INACTIVE INGREDIENT0841698D2F1
PPG-15 STEARYL ETHER BENZOATEINACTIVE INGREDIENT80D2J6361M1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
TRIBEHENININACTIVE INGREDIENT8OC9U7TQZ01

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51531-085051531-0850-1, 51531-0850-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
ISODODECANEA8289P68Y2IACT
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMERO4I3UFO6ZFIACT
VINYLPYRROLIDONE/HEXADECENE COPOLYMERKFR5QEN0N9IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
POLYESTER-70841698D2FIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
TRIBEHENIN8OC9U7TQZ0IACT
DIPROPYLENE GLYCOL DIBENZOATE6OA5ZDY41OIACT
PPG-15 STEARYL ETHER BENZOATE80D2J6361MIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 3 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mary Kay Foundation PrimerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMary Kay Inc.59d25b44-1adb-4790-8ce6-2d847a06b8b32024-12-17WarningsExact identifier
ndc (package): 51531-0850-0
ndc (package): 51531-0850-1
ndc (product): 51531-0850
ndc11 (package): 51531085001
ndc11 (package): 51531085000
spl id: 297c8c3c-d5db-d017-e063-6294a90a65ce
spl set id: 59d25b44-1adb-4790-8ce6-2d847a06b8b3

Reported adverse events (FAERS/openFDA)#

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