FDA.reportPublic FDA data

CVS Health SPF 55 Ultra Sheer Lotion

Manufacturer
CVS Pharmacy
Effective date
2024-10-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:28:37

Label at a glance#

ProductCVS Health SPF 55 Ultra Sheer
Active ingredientOCTOCRYLENE, OCTISALATE, HOMOSALATE, AVOBENZONE
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: 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 ...

Storage and handling

• protect the 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 10.0%, Octisalate 5.0%, Octocrylene 7.0%,

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

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

reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours

  • children under 6 months: 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, butyloctyl salicylate, tridecyl salicylate, styrene/acrylates copolymer, silica, VP/hexadecene copolymer, behenyl alcohol, glyceryl stearate, PEG-100 stearate, phenoxyethanol, dimethicone, tocopheryl acetate, ethylhexylglycerin, caprylyl methicone, ethylhexyl stearate, trideceth-6, trimethylsiloxysilicate, sodium polyacrylate, xanthan gum, disodium EDTA, fragrance

Other information

STORAGE AND HANDLING SECTION

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

• may stain or damage some fabrics, materials or surfaces

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Health

ULTRA SHEER LOTION

BROAD SPECTRUM SPF 55 SUNSCREEN

3.0 FL OZ (89 mL)

CVS37971A1CVS37971A1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-375-09CVS Health SPF 55 Ultra Sheer89 mL in 1 TUBELOTION892

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-375CVS HEALTH SPF 55 ULTRA SHEER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [CVS PHARMACY]2Current NDC, Legacy NDC, 1 package rows20241024_c617cdec-b489-22d2-e053-2995a90a1ec6.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-37569842-375-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
EDETATE DISODIUM7FLD91C86KIACT
TRIDECETH-63T5PCR2H0CIACT
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)25LXE464L2IACT
XANTHAN GUMTTV12P4NEEIACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
DIMETHICONE92RU3N3Y1OIACT
WATER059QF0KO0RIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMERV5RS026Q0HIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
VINYLPYRROLIDONE/HEXADECENE COPOLYMERKFR5QEN0N9IACT
DOCOSANOL9G1OE216XYIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
HOMOSALATEV06SV4M95SACTIB
AVOBENZONEG63QQF2NOXACTIB
TRIDECYL SALICYLATEAZQ08K38Z1IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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 55 Ultra SheerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacyc617cdec-b489-22d2-e053-2995a90a1ec62024-10-22WarningsExact identifier
ndc (package): 69842-375-09
ndc (product): 69842-375
ndc11 (package): 69842037509
spl id: 25149f86-c8a9-eb49-e063-6394a90ad7a2
spl set id: c617cdec-b489-22d2-e053-2995a90a1ec6

Reported adverse events (FAERS/openFDA)#

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