FDA.reportPublic FDA data

CVS Health SPF 50 Clear Spray

Manufacturer
CVS PHARMACY
Effective date
2024-07-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:15:28

Label at a glance#

ProductCVS Health SPF 50 Clear
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure13 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

• Spray liberally and spread evenly by hand 15 minutes before sun exposure • Hold can 4-6 inches away from the skin to apply • Do not spray directly into face. Spray into hands then apply to face • Do not apply in windy conditions • Use in a well-ventilated area • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • children under 6 months of age: Ask a do...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%
Homosalate 10.0%
Octisalate 5.0%
Octocrylene 4.0%

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

FLAMMABLE:

SAFE HANDLING WARNING SECTION

• do not use near heat, flame or while smoking

• avoid long term storage above 104°F (40°C)

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. • Keep away from face to avoid breathing it. • do not puncture or incinerate. Contents under pressure. • do not store at temperatures above 120° F.

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

• Spray liberally and spread evenly by hand 15 minutes before sun exposure

• Hold can 4-6 inches away from the skin to apply

• Do not spray directly into face. Spray into hands then apply to face

• Do not apply in windy conditions

• Use in a well-ventilated area

• reapply:

• after 80 minutes of swimming or sweating

• immediately after towel drying

• 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

SPL UNCLASSIFIED SECTION

• 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

alcohol denat., butyloctyl salicylate, acrylates/octylacrylamide copolymer, panthenol, tocopherol, fragrance, stearoxytrimethylsilane, caprylic/capric triglyceride, glycerin

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS44455A1CVS44455A1

CVS32386DCVS32386D

CVS32293D1CVS32293D1

CVS42058ACVS42058A

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-036-37CVS Health SPF 50 Clear156 g in 1 CANSPRAY1562
51316-036-48CVS Health SPF 50 Clear258 g in 1 CANSPRAY2582
51316-036-63CVS Health SPF 50 Clear2 in 1 PACKAGESPRAY22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-036CVS HEALTH SPF 50 CLEAR (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE) SPRAY [CVS PHARMACY]2Current NDC, 3 package rows20240718_f42402ff-0d70-9231-e053-2995a90aa46d.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-03651316-036-37, 51316-036-63, 51316-036-48

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW)JU3XHR8VWKIACT
PANTHENOLWV9CM0O67ZIACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
STEAROXYTRIMETHYLSILANE9862TW94B2IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERINPDC6A3C0OXIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
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 SPF 50 ClearAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENECVS PHARMACYf42402ff-0d70-9231-e053-2995a90aa46d2024-07-16WarningsExact identifier
ndc (package): 51316-036-48
ndc (package): 51316-036-63
ndc (package): 51316-036-37
ndc (product): 51316-036
ndc11 (package): 51316003648
ndc11 (package): 51316003663
ndc11 (package): 51316003637
spl id: 1d63c260-60b7-95ec-e063-6294a90a6910
spl set id: f42402ff-0d70-9231-e053-2995a90aa46d

Reported adverse events (FAERS/openFDA)#

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