FDA.reportPublic FDA data

SUNSCREEN BROAD SPECTRUM SPF 50 FACE AND BODY

Manufacturer
Mary Kay Inc.
Effective date
2025-01-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:56:36

Label at a glance#

ProductSUNSCREEN BROAD SPECTRUM SPF 50 FACE AND BODY
Active ingredientOCTOCRYLENE, AVOBENZONE, OCTISALATE
Label structure9 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Adults and children over 6 months of age: ■ apply liberally 15 minutes before sun exposure. ■ Reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • 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 value of 15 or higher and oth...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3% (w/w)

Octisalate 4.5% (w/w)

Octocrylene 9% (w/w)

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

on broken skin.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

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

Adults and children over 6 months of age: ■ apply liberally 15 minutes before sun exposure. ■ Reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • 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 value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. – 2 p.m.; and • wear long-sleeved shirts, pants, hats, and sunglasses. ■ Children under 6 months: Ask a doctor.

Other information

OTHER SAFETY INFORMATION

■ protect the product in this container from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water/eau/aqua, propanediol, VP/eicosene copolymer, glycerin, caprylyl methicone, phenoxyethanol, acrylates/C10-30 alkyl acrylate crosspolymer, cetearyl alcohol, hydroxyacetophenone, disodium edta, xanthan gum, potassium hydroxide, ethylhexylglycerin.

Questions?

OTC - QUESTIONS SECTION

1-800-627-9529

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MARY KAY

50

SUNSCREEN BROAD SPECTRUM SPF 50 FACE AND BODY water-resistant (80 minutes)

4 FL. OZ. / 118 mL

PRINCIPAL DISPLAY PANELPRINCIPAL DISPLAY PANEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51531-7287-1SUNSCREEN BROAD SPECTRUM SPF 50 FACE AND BODY118 g in 1 TUBELOTION1181
51531-7287-1SUNSCREEN BROAD SPECTRUM SPF 50 FACE AND BODY1 in 1 CARTONLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51531-7287SUNSCREEN BROAD SPECTRUM SPF 50 FACE AND BODY (AVOBENZONE/OCTISALATE/OCTOCRYLENE) LOTION [MARY KAY INC.]1Current NDC, 2 package rows20250306_2c4eaf2e-b034-8185-e063-6394a90a8275.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51531-728751531-7287-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPRYLYL METHICONEQ95M2P1KJLIACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
CETEARYL ALCOHOL2DMT128M1SIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
OCTISALATE4X49Y0596WACTIB
WATER059QF0KO0RIACT
PROPANEDIOL5965N8W85TIACT
EDETATE DISODIUM7FLD91C86KIACT
XANTHAN GUMTTV12P4NEEIACT
PHENOXYETHANOLHIE492ZZ3TIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT

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
SUNSCREEN BROAD SPECTRUM SPF 50 FACE AND BODYAVOBENZONE/OCTISALATE/OCTOCRYLENEMary Kay Inc.2c4eaf2e-b034-8185-e063-6394a90a82752025-01-22WarningsExact identifier
ndc (package): 51531-7287-1
ndc (product): 51531-7287
ndc11 (package): 51531728701
spl id: 2c4eaf2e-b035-8185-e063-6394a90a8275
spl set id: 2c4eaf2e-b034-8185-e063-6394a90a8275

Reported adverse events (FAERS/openFDA)#

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