FDA.reportPublic FDA data

Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very Deep

Manufacturer
Mary Kay Inc. | Englewood Lab Inc.
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:44:11

Label at a glance#

ProductMary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very 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
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51531-6620-12020-07-22C16284748780-1ab0e2407-2fc3-f274-e053-dbdaa90a6471Mary Kay CC Cream Sunscreen SPF 15 Very Deep Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51531-6620-1Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very Deep29 mL in 1 TUBECREAM299
51531-6620-1Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very Deep1 in 1 CARTONCREAM19
51531-6620-3Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very Deep1 mL in 1 PACKETCREAM19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51531-6620MARY KAY CC CREAM SUNSCREEN BROAD SPECTRUM SPF 15 VERY DEEP (HOMOSALATE, OCTINOXATE, OXYBENZONE) CREAM [MARY KAY INC.]9Current NDC, Legacy NDC, 3 package rows20241219_404990e4-9499-4186-b39d-afc31834d334.zip

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
51531-662051531-6620-1, 51531-6620-3

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
GLYCERINPDC6A3C0OXIACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
NIACINAMIDE25X51I8RD4IACT
MICAV8A1AW0880IACT
PEG-9 DIMETHICONE (400 CST)9OZ27X065DIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
ASCORBYL GLUCOSIDE2V52R0NHXWIACT
MILK THISTLEU946SH95EEIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SALIX NIGRA BARKQU52J3A5B3IACT
SALICYLIC ACIDO414PZ4LPZIACT
ADENOSINEK72T3FS567IACT
DISODIUM STEAROYL GLUTAMATE45ASM2L11MIACT
XANTHAN GUMTTV12P4NEEIACT
DIPROPYLENE GLYCOLE107L85C40IACT
EDETATE DISODIUM7FLD91C86KIACT
CYCLOMETHICONE 6XHK3U310BAIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
TOCOPHEROLR0ZB2556P8IACT
SORBIC ACIDX045WJ989BIACT
SODIUM BENZOATEOJ245FE5EUIACT
BENZYL ALCOHOLLKG8494WBHIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
DIMETHICONE/PEG-10/15 CROSSPOLYMER21AS8B1BSSIACT

Source Document#

Source XML

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 Very DeepHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.404990e4-9499-4186-b39d-afc31834d3342024-12-17WarningsExact identifier
ndc (package): 51531-6620-3
ndc (package): 51531-6620-1
ndc (product): 51531-6620
ndc11 (package): 51531662003
ndc11 (package): 51531662001
spl id: 297a1692-6485-f88e-e063-6394a90aa25a
spl set id: 404990e4-9499-4186-b39d-afc31834d334

Reported adverse events (FAERS/openFDA)#

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