Drug Facts

Manufacturer
L'Oreal USA Products Inc | L'Oreal USA Products, Inc
Effective date
2024-12-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:48:25

Label at a glance#

ProductLa Roche Posay Laboratoire Dermatologique Anthelios UV Tone Broad Spectrum SPF 50 Sunscreen
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure14 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 generously 15 minutes before sun exposure · reaply 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 the 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

Avobenzone 3%

Homosalate 7%

Octisalate 5%

Octocrylene 7%

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 generously 15 minutes before sun exposure
· reaply 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 the 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, glycerin, C15-19 alkane, niacinamide, propanediol, C12-22 alkyl acrylate/hydroxyethylacrylate copolymer, tocopherol, sodium stearoyl glutamate, cetearyl alcohol, sclerotium gum, hydroxyacetophenone, caprylyl glycol, sodium starch octenylsuccinate, glyceryl stearate, jojoba esters, helianthus annuus (sunflower) seed wax, hydroxypropyl starch phosphate, trisodium ethylenediamine disuccinate, pentylene glycol, diethylhexyl syringylidenemalonate, cassia alata leaf extract, maltodextrin, sodium hydroxide, caprylic/capric triglyceride, polyglycerin-3, citric acid

Questions or comments?

OTC - QUESTIONS SECTION

1-888- LRP-LABO  1-888-577-5226

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-212-01La Roche Posay Laboratoire Dermatologique Anthelios UV Tone Broad Spectrum SPF 50 Sunscreen50 mL in 1 TUBELOTION501
49967-212-01La Roche Posay Laboratoire Dermatologique Anthelios UV Tone Broad Spectrum SPF 50 Sunscreen1 in 1 CARTONLOTION11
49967-212-02La Roche Posay Laboratoire Dermatologique Anthelios UV Tone Broad Spectrum SPF 50 Sunscreen5 mL in 1 TUBELOTION51
49967-212-02La Roche Posay Laboratoire Dermatologique Anthelios UV Tone Broad Spectrum SPF 50 Sunscreen15 in 1 PACKAGELOTION151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-212LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS UV TONE BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) LOTION [L'OREAL USA PRODUCTS INC]1Current NDC, 4 package rows20241225_46aa9917-52ac-4c57-afde-366d2d3ca200.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
49967-21249967-212-01, 49967-212-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 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
La Roche Posay Laboratoire Dermatologique Anthelios UV Tone Broad Spectrum SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc46aa9917-52ac-4c57-afde-366d2d3ca2002024-12-23WarningsExact identifier
ndc (package): 49967-212-02
ndc (package): 49967-212-01
ndc (product): 49967-212
ndc11 (package): 49967021202
ndc11 (package): 49967021201
spl id: 30e06498-a38a-439b-9aaa-d7a56cfd37d3
spl set id: 46aa9917-52ac-4c57-afde-366d2d3ca200

Reported adverse events (FAERS/openFDA)#

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