FDA.reportPublic FDA data

Leg and Body Makeup Broad Spectrum SPF 25

Manufacturer
Baxter of California, LLC | Cosmax USA, 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#

ProductLeg and Body Makeup Broad Spectrum SPF 25
Active ingredientOCTISALATE, OCTOCRYLENE
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...

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 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.

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.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs

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 10 a.m. – 2 p.m. ● 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, cyclopentasiloxane, isododecane, isononyl isononanoate, glycerin, cetyl PEG/PPG 10/1 dimethicone, dimethicone, magnesium sulfate, polyglyceryl-4 isostearate, dimethicone/PEG-10/15 crosspolymer, disodium stearoyl glutamate, disteardimonium hectorite, phenoxyethanol, polybutene, methylparaben, alcohol denat., chlorphenesin, acrylonitrile/methyl methacrylate/vinylidene chloride copolymer, butylparaben, aluminum hydroxide, sodium hydroxide, isobutane, dipropylene glycol, sodium citrate, tocopherol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate; may contain: titanium dioxide, iron oxides

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Leg and Body MakeupLeg and Body Makeup

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84203-002-01Leg and Body Makeup Broad Spectrum SPF 251 in 1 CARTONLIQUID13
84203-002-01Leg and Body Makeup Broad Spectrum SPF 25100 mL in 1 TUBELIQUID1003

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
84203-00284203-002-01

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
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
BUTYLPARABEN3QPI1U3FV8IACT
HYALURONATE SODIUMYSE9PPT4THIACT
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
METHYLPARABENA2I8C7HI9TIACT
CHLORPHENESINI670DAL4SZIACT
DIPROPYLENE GLYCOLE107L85C40IACT
FERRIC OXIDE RED1K09F3G675IACT
ISODODECANEA8289P68Y2IACT
GLYCERINPDC6A3C0OXIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
DIMETHICONE92RU3N3Y1OIACT
ALCOHOL3K9958V90MIACT
TOCOPHEROLR0ZB2556P8IACT
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)255PIF62MSIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DISODIUM STEAROYL GLUTAMATE45ASM2L11MIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYBUTENE (1400 MW)1NA5AO9GH7IACT
ISOBUTANEBXR49TP611IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
SODIUM CITRATE1Q73Q2JULRIACT

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
Leg and Body Makeup Broad Spectrum SPF 25OCTISALATE 3.2% OCTOCRYLENE 6%Baxter of California, LLC14adc826-6e9d-382a-e063-6294a90a5d792025-07-24WarningsExact identifier
ndc (package): 84203-002-01
ndc (product): 84203-002
ndc11 (package): 84203000201
spl id: 3aaeeafe-b737-c1e4-e063-6394a90af100
spl set id: 14adc826-6e9d-382a-e063-6294a90a5d79

Reported adverse events (FAERS/openFDA)#

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