FDA.reportPublic FDA data

Sunscreen

Manufacturer
Baxter of California, LLC | Dimensional Merchandising, Inc
Effective date
2025-07-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:08:31

Label at a glance#

ProductSunscreen
Active ingredientTITANIUM DIOXIDE
Label structure9 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

For sunscreen use: apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating 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 th...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octisalate 3.2%

Octocrylene 6%

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 damamged skin or broken skin

When using this product

OTC - WHEN USING SECTION

Keep out of eyes.

Rinse with water to remove

Stop use and ask 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

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • 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 10am-2pm
    • wear long sleeved shirts, pants, hats, and sunglasses
    • children under 6 months of age: Ask a doctor

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, undecane, dimethicone, glycerin, tridecane, polyglyceryl-4 isostearate, pentylene
glycol, cetyl PEG/PPG-10/1, hexyl laurate, magnesium sulfate, disteardimonium hectorite,
trihydroxystearin, cellulose gum, aluminum hydroxide, disodium stearoyl glutamate,
acetylated glycol stearate, acrylates copolymer, ethylhexylglyceerin; may contain:
titanium dioxide, iron oxides

Questions or Comments?

OTC - QUESTIONS SECTION

1-877-900-6700
Monday - Friday (9 a.m. - 5 p.m. EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Liquid camo labelLiquid camo label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84203-001-01Sunscreen30 mL in 1 TUBELIQUID303

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84203-00184203-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
FERRIC OXIDE RED1K09F3G675IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
UNDECANEJV0QT00NUEIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
TRIDECANEA3LZF0L939IACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
PENTYLENE GLYCOL50C1307PZGIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
HEXYL LAURATE4CG9F9W01QIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
TRIHYDROXYSTEARIN06YD7896S3IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
DISODIUM STEAROYL GLUTAMATE45ASM2L11MIACT
ACETYLATED GLYCOL STEARATEK71M6R9N7EIACT

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
SunscreenTITANIUM DIOXIDE 6.8%Baxter of California, LLC146030bc-2bf4-25ea-e063-6294a90a46132025-07-24WarningsExact identifier
ndc (package): 84203-001-01
ndc (product): 84203-001
ndc11 (package): 84203000101
spl id: 3aaee79a-2b7f-1b14-e063-6294a90af5b1
spl set id: 146030bc-2bf4-25ea-e063-6294a90a4613

Reported adverse events (FAERS/openFDA)#

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