FDA.reportPublic FDA data

CVS Health 50 Clear Zinc Lotion Broad Spectrum SPF 50 Sunscreen

Manufacturer
CVS PHARMACY
Effective date
2024-10-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:27:21

Label at a glance#

ProductCVS Health 50 Clear Zinc Broad Spectrum SPF 50 Sunscreen
Active ingredientZINC OXIDE, OCTOCRYLENE
Label structure12 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 children under 6 months of age: Ask a doctor 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 ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octocrylene 4.0%, Zinc Oxide 5.0%

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 if

OTC - ASK DOCTOR SECTION

• rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If 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
  • children under 6 months of age: Ask a doctor
  • 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.

• wear long-sleeved shirts, pants, hats, and sunglasses

Other information

OTHER SAFETY INFORMATION

  • protect the product in this container from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER, ETHYLHEXYL STEARATE, DIISOPROPYL ADIPATE, CETY DIMETHICONE, CETY PEG/PPG-10/1 DIMETHICONE, HYDROGENATED CASTOR OIL, POLYGLYCERYL-4 ISOSTEARATE, HEXYL LAURATE, BEESWAX, ISOHEXADECANE, PHENOXYETHANOL, SILICA, ETHYLHEXYLGLYCERIN, TRIETHOXYCAPRYLYLSILANE, DIMETHICONE, SODIUM CHLORIDE, DISODIUM EDTA, ALOE BARBADENSIS LEAF POWDER, SODIUM ASCORBYL PHOSPHATE, TOCOPHEROL,

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS41939A1CVS41939A1

CVS31368ECVS31368E

CVS31368E-1CVS31368E-1

CVS31368E-2CVS31368E-2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-043-13CVS Health 50 Clear Zinc Broad Spectrum SPF 50 Sunscreen118 mL in 1 TUBELOTION1182
51316-043-85CVS Health 50 Clear Zinc Broad Spectrum SPF 50 Sunscreen59 mL in 1 JARLOTION592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-043CVS HEALTH 50 CLEAR ZINC BROAD SPECTRUM SPF 50 SUNSCREEN (OCTOCRYLENE, ZINC OXIDE) LOTION [CVS PHARMACY]2Current NDC, 2 package rows20241019_fa19e9d3-6ab8-cbd6-e053-6294a90aae9b.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-04351316-043-13, 51316-043-85

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
SODIUM CHLORIDE451W47IQ8XIACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
WHITE WAX7G1J5DA97FIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
HEXAMETHYLDISILOXANED7M4659BPUIACT
CETYL DIMETHICONE 45IK315POC44IACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HEXYL LAURATE4CG9F9W01QIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
ISOHEXADECANE918X1OUF1EIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
PHENOXYETHANOLHIE492ZZ3TIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
WATER059QF0KO0RIACT
EDETATE DISODIUM7FLD91C86KIACT
ZINC OXIDESOI2LOH54ZACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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
CVS Health 50 Clear Zinc Broad Spectrum SPF 50 SunscreenOCTOCRYLENE, ZINC OXIDECVS PHARMACYfa19e9d3-6ab8-cbd6-e053-6294a90aae9b2024-10-17WarningsExact identifier
ndc (package): 51316-043-13
ndc (package): 51316-043-85
ndc (product): 51316-043
ndc11 (package): 51316004385
ndc11 (package): 51316004313
spl id: 24af5a00-b01b-5d28-e063-6394a90a55ba
spl set id: fa19e9d3-6ab8-cbd6-e053-6294a90aae9b

Reported adverse events (FAERS/openFDA)#

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