Dermablend Professional Leg and Body Makeup Broad Spectrum SPF 25 Sunscreen

Manufacturer
L'Oreal USA Products Inc | Cosmax USA, Inc.
Effective date
2024-12-28
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 00:49:29

Label at a glance#

ProductDermablend Professional Leg and Body Makeup Broad Spectrum SPF 25 Sunscreen
Active ingredientOCTISALATE, OCTOCRYLENE
Label structure13 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...

Storage and handling

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

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 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

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

STORAGE AND HANDLING SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-877-900-6700

Monday - Friday (9 a.m. - 5 p.m. EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49967-906-012023-12-27C16284748780-10191ceaa-6955-198a-e063-dbdaa90aec3eDrug Facts
49967-906-012023-07-28C16284748780-10191ceaa-6955-198a-e063-dbdaa90aec3eDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-906-01Dermablend Professional Leg and Body Makeup Broad Spectrum SPF 25 Sunscreen100 mL in 1 TUBELOTION10010
49967-906-01Dermablend Professional Leg and Body Makeup Broad Spectrum SPF 25 Sunscreen1 in 1 CARTONLOTION110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-906DERMABLEND PROFESSIONAL LEG AND BODY MAKEUP BROAD SPECTRUM SPF 25 SUNSCREEN (OCTISALATE AND OCTOCRYLENE) LOTION [L'OREAL USA PRODUCTS INC]10Current NDC, Legacy NDC, 2 package rows20241230_df62e1c2-ce72-4ded-8985-156dce9ff41d.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-90649967-906-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

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
Dermablend Professional Leg and Body Makeup Broad Spectrum SPF 25 SunscreenOCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incdf62e1c2-ce72-4ded-8985-156dce9ff41d2024-12-28WarningsExact identifier
ndc (package): 49967-906-01
ndc (product): 49967-906
ndc11 (package): 49967090601
spl id: 234c562a-5b25-44b4-9ace-7c1021bf8cf3
spl set id: df62e1c2-ce72-4ded-8985-156dce9ff41d

Reported adverse events (FAERS/openFDA)#

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