FDA.reportPublic FDA data

CVS Health SPF 30 Ultra Sheer Lotion

Manufacturer
CVS PHARMACY
Effective date
2024-10-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:27:20

Label at a glance#

ProductCVS Health SPF 30 Ultra Sheer
Active ingredientHOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATE
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 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 other sun pr...

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 8.0%, 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 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.
  • 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 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, tridecyl salicylate, silica, dimethicone, potassium cetyl phosphate, beeswax, benzyl alcohol, glyceryl stearate, PEG-100 stearate, cetyl dimethicone, caprylyl methicone, caprylyl glycol, ethyhexylglycerin, dimethicone/PEG-10/15 crosspolymer, sodium polyacrylate, behenyl alcohol, xanthan gum, ethylhexyl stearate, acrylates/C12-22 alkyl methacrylate copolymer, disodium EDTA, chlorphenesin, fragrance, trideceth-6, propylene glycol

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS30751ACVS30751A

CVS62003ACVS62003A

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-029-09CVS Health SPF 30 Ultra Sheer89 mL in 1 TUBELOTION892

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-029CVS HEALTH SPF 30 ULTRA SHEER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [CVS PHARMACY]2Current NDC, 1 package rows20241019_f32ec4ef-352e-6a78-e053-2995a90af491.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-02951316-029-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER7K68DGG29PIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERYL 1-STEARATE258491E1RZIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
CHLORPHENESINI670DAL4SZIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DOCOSANOL9G1OE216XYIACT
DIMETHICONE92RU3N3Y1OIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PEG-100 STEARATEYD01N1999RIACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
BENZYL ALCOHOLLKG8494WBHIACT
XANTHAN GUMTTV12P4NEEIACT
CETYL DIMETHICONE 45IK315POC44IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
WATER059QF0KO0RIACT
WHITE WAX7G1J5DA97FIACT
TRIDECETH-63T5PCR2H0CIACT
EDETATE DISODIUM7FLD91C86KIACT
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
DIMETHICONE/PEG-10/15 CROSSPOLYMER21AS8B1BSSIACT
TRIDECYL SALICYLATEAZQ08K38Z1IACT

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 30 Ultra SheerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf32ec4ef-352e-6a78-e053-2995a90af4912024-10-17WarningsExact identifier
ndc (package): 51316-029-09
ndc (product): 51316-029
ndc11 (package): 51316002909
spl id: 24af2217-6f65-ec0b-e063-6394a90a7ddc
spl set id: f32ec4ef-352e-6a78-e053-2995a90af491

Reported adverse events (FAERS/openFDA)#

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