FDA.reportPublic FDA data

CVS Health Ultra Sheer SPF 100 Sunscreen Lotion

Manufacturer
CVS PHARMACY
Effective date
2024-10-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:28:37

Label at a glance#

ProductCVS Health Ultra Sheer SPF 100 Sunscreen
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
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 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 ot...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 10.0%, Oxybenzone 6.0%

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 - STOP USE 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

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

STORAGE AND HANDLING SECTION

• protect this 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, styrene/acylates copolymer, cyclopentasiloxane, silica, beeswax, glyceryl stearate, PEG-100 stearate, acrylates/dimethicone copolymer, acrylates/C10-30 alkyl acrylate crosspolymer, ethylhexylglycerin, tocopheryl, caprylyl glycol, dipotassium glycyrrhizate, disodium EDTA, triethanolamine, phenoxyethanol, fragrance.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS34436ACVS34436A

CVS61606ACVS61606A

CVS33711ACVS33711A

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-339-09CVS Health Ultra Sheer SPF 100 Sunscreen89 mL in 1 TUBELOTION894

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-339CVS HEALTH ULTRA SHEER SPF 100 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [CVS PHARMACY]4Current NDC, Legacy NDC, 1 package rows20241024_c52a7e9b-5401-f6e7-e053-2995a90a9519.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-33969842-339-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OIACT
GLYCERYL STEARATE/PEG-100 STEARATERD25J5V947IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMERV5RS026Q0HIACT
CARBOMER COPOLYMER TYPE A71DD5V995LIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CAPRYLYL GLYCOL00YIU5438UIACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
TROLAMINE9O3K93S3TKIACT
WHITE WAX7G1J5DA97FIACT
CYCLOMETHICONE 50THT5PCI0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB

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 Ultra Sheer SPF 100 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS PHARMACYc52a7e9b-5401-f6e7-e053-2995a90a95192024-10-22WarningsExact identifier
ndc (package): 69842-339-09
ndc (product): 69842-339
ndc11 (package): 69842033909
spl id: 251490e6-e049-e9db-e063-6394a90a997a
spl set id: c52a7e9b-5401-f6e7-e053-2995a90a9519

Reported adverse events (FAERS/openFDA)#

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