Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Medium to Deep

Manufacturer
Mary Kay Inc. | Englewood Lab Inc.
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:44:13

Label at a glance#

ProductMary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Medium to Deep
Active ingredientHOMOSALATE, OCTINOXATE, OXYBENZONE
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

Store at 25°C (77°F). Do not freeze or refrigerate.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 5%

Octinoxate 6.5%

Oxybenzone 1.2 %

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

Other information

STORAGE AND HANDLING SECTION

  • Store at 25°C (77°F). Do not freeze or refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, cyclopentasiloxane, butylene glycol, glycerin, PEG-9 polydimethylsiloxyethyl dimethicone, niacinamide, mica, PEG-9 dimethicone, magnesium sulfate, ascorbyl glucoside, silybum marianum fruit extract, tocopheryl acetate, salix nigra (willow) bark extract, salicylic acid, adenosine, dimethicone/PEG-10/15 crosspolymer, disodium stearoyl glutamate, xanthan gum, dipropylene glycol, disodium EDTA, cyclohexasiloxane, sodium citrate, tocopherol, sorbic acid, sodium benzoate, benzyl alcohol, aluminum hydroxide, titanium dioxide, iron oxides

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

cc cream

sunscreen broad

spectrum spf 15

cream

1 FL. OZ. / 29 mL

image of cartonimage of carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51531-2824-12020-07-22C16284748780-1ab0e2407-2fc0-f274-e053-dbdaa90a6471Mary Kay CC Cream Sunscreen SPF 15 Medium to Deep Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51531-2824-1Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Medium to Deep1 in 1 CARTONCREAM18
51531-2824-1Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Medium to Deep29 mL in 1 TUBECREAM298
51531-2824-3Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Medium to Deep1 mL in 1 PACKETCREAM18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51531-2824MARY KAY CC CREAM SUNSCREEN BROAD SPECTRUM SPF 15 MEDIUM TO DEEP (HOMOSALATE, OCTINOXATE, OXYBENZONE) CREAM [MARY KAY INC.]8Current NDC, Legacy NDC, 3 package rows20241219_6028e210-a8a3-4d84-a462-16a414c31052.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HOMOSALATEACTIVE INGREDIENTV06SV4M95S1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y1
HOMOSALATEACTIVE MOIETYV06SV4M95S1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OXYBENZONEACTIVE MOIETY95OOS7VE0Y1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
ADENOSINEINACTIVE INGREDIENTK72T3FS5671
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN01
ASCORBYL GLUCOSIDEINACTIVE INGREDIENT2V52R0NHXW1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R1
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BA1
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C401
DISODIUM STEAROYL GLUTAMATEINACTIVE INGREDIENT45ASM2L11M1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6751
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3571
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
MAGNESIUM SULFATEINACTIVE INGREDIENTDE08037SAB1
MICAINACTIVE INGREDIENTV8A1AW08801
MILK THISTLEINACTIVE INGREDIENTU946SH95EE1
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD41
PEG-9 DIMETHICONE (400 CST)INACTIVE INGREDIENT9OZ27X065D1
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONEINACTIVE INGREDIENTTYP81E471F1
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZ1
SALIX NIGRA BARKINACTIVE INGREDIENTQU52J3A5B31
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989B1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P81
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51531-282451531-2824-1, 51531-2824-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

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 3 · 156 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE / ORAL11 mgExact identifier — unii candidate
30 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / TRANSDERMAL296 mgExact identifier — unii candidate
9 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, EXTENDED RELEASE / ORAL15 mgExact identifier — unii candidate
60 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii candidate
60 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii+route
9 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE / ORAL14 mgExact identifier — unii candidate
60 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
60 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET / SUBLINGUAL1 mgExact identifier — unii candidate
60 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
60 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
9 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, COATED / ORAL0.01 mgExact identifier — unii candidate
60 equally ranked IID candidates
NIACINAMIDENIACINAMIDE25X51I8RD4CREAM / TOPICALNAExact identifier — unii+route+dosage form
3 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
9 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii+route
9 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, FILM COATED / ORAL6 mgExact identifier — unii candidate
60 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, DELAYED RELEASE / ORAL3 mgExact identifier — unii candidate
60 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
60 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET, FILM COATED / ORAL0.2 mgExact identifier — unii candidate
30 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, COATED / ORAL1 mgExact identifier — unii candidate
60 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
30 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTFILM / BUCCAL0.27 mgExact identifier — unii candidate
60 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, CHEWABLE / ORAL14 mgExact identifier — unii candidate
60 equally ranked IID candidates
MAGNESIUM SULFATEMAGNESIUM SULFATEDE08037SABSOAP / TOPICAL0.2 %w/wExact identifier — unii+route
3 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / BUCCAL30 mgExact identifier — unii candidate
9 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET, COATED / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
30 equally ranked IID candidates
NIACINAMIDENIACINAMIDE25X51I8RD4CREAM / TOPICALNAExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
30 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, COATED / ORAL1 mgExact identifier — unii candidate
60 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40SYSTEM / TRANSDERMAL6 mgExact identifier — unii candidate
9 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / BUCCAL30 mgExact identifier — unii candidate
9 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40SYSTEM / TRANSDERMAL6 mgExact identifier — unii candidate
9 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii+route
9 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTGRANULE, FOR SUSPENSION / ORAL11 mgExact identifier — unii candidate
60 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
30 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, DELAYED RELEASE / ORAL7 mgExact identifier — unii candidate
60 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET / ORAL2 mgExact identifier — unii candidate
30 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE / ORAL14 mgExact identifier — unii candidate
60 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
30 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MAGNESIUM SULFATEMAGNESIUM SULFATEDE08037SABSOAP / TOPICAL0.2 %w/wExact identifier — unii+route
3 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357POWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE, EXTENDED RELEASE / ORAL1.49 mgExact identifier — unii candidate
30 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, COATED / ORAL0.01 mgExact identifier — unii candidate
60 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTFILM / BUCCAL0.27 mgExact identifier — unii candidate
60 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE, COATED / ORAL0.11 mgExact identifier — unii candidate
30 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET / SUBLINGUAL1 mgExact identifier — unii candidate
60 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
3 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, COATED / ORAL0.01 mgExact identifier — unii candidate
60 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEECREAM / TOPICAL46 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
60 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET, COATED / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET / ORAL24 mgExact identifier — unii candidate
60 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCREAM / TOPICAL80 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357POWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
30 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 CC Cream Sunscreen Broad Spectrum SPF 15 Medium to DeepHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.6028e210-a8a3-4d84-a462-16a414c310522024-12-17WarningsExact identifier
ndc (package): 51531-2824-3
ndc (package): 51531-2824-1
ndc (product): 51531-2824
ndc11 (package): 51531282401
ndc11 (package): 51531282403
spl id: 297a27f1-0896-38aa-e063-6394a90adea1
spl set id: 6028e210-a8a3-4d84-a462-16a414c31052

Reported adverse events (FAERS/openFDA)#

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