Drug Facts

Manufacturer
L'Oreal USA Products Inc | L'Oreal USA, Inc.
Effective date
2023-12-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:06:17

Label at a glance#

ProductLa Roche Posay Laboratoire Dermatologique Anthelios 60 Face and Body Cooling Water Broad Spectrum SPF 60 Sunscreen Wa...
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
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 generously 15 minutes before sun exposure ●  reapply:    ●  after 80 minutes of swimming or sweating     ●  immediately after towel drying     ●  at least every 2 hours ● 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 ...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10.72%

Octisalate 3.21%

Octocrylene 6%

Oxybenzone 3.86

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

●  reapply:

   ●  after 80 minutes of swimming or sweating

    ●  immediately after towel drying

    ●  at least every 2 hours

● 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, dimethicone, alcohol denat., styrene/acrylates copolymer, acrylates/dimethicone copolymer, phenoxyethanol, propylene glycol, caprylyl glycol, sodium polyacrylate, silica, PEG-8 laurate, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, tocopherol, menthyl lactate, diethylhexyl syringylidenemalonate, cassia alata leaf extract, maltodextrin

Questions or comments?

OTC - QUESTIONS SECTION

1-888-LRP-LABO 1-888-577-5226

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-038-01La Roche Posay Laboratoire Dermatologique Anthelios 60 Face and Body Cooling Water Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes150 mL in 1 TUBELOTION1504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-038LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 60 FACE AND BODY COOLING WATER BROAD SPECTRUM SPF 60 SUNSCREEN WATER RESISTANT 80 MINUTES (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [L'OREAL USA PRODUCTS INC]4Current NDC, Legacy NDC, 1 package rows20240101_e72ae48f-e4ec-458b-ae2b-bd6cb98552f9.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-03849967-038-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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 60 Face and Body Cooling Water Broad Spectrum SPF 60 Sunscreen Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONEL'Oreal USA Products Ince72ae48f-e4ec-458b-ae2b-bd6cb98552f92023-12-31WarningsExact identifier
ndc (package): 49967-038-01
ndc (product): 49967-038
ndc11 (package): 49967003801
spl id: 752b3e38-a6f2-471f-a3a0-046b473a1b6d
spl set id: e72ae48f-e4ec-458b-ae2b-bd6cb98552f9

Reported adverse events (FAERS/openFDA)#

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