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Drug Facts

Manufacturer
L'Oreal USA Products Inc | L'Oreal USA, Inc.
Effective date
2025-07-10
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:07:00

Label at a glance#

ProductLa Roche Posay Laboratoire Dermatologique Anthelios 60 Breakout Free Oil Free Face Dry Touch Broad Spectrum SPF 60 Su...
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure15 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 15%

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

●  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, silica, dicaprylyl carbonate, styrene/acrylates copolymer, butyloctyl salicylate, methyl methacrylate crosspolymer, nylon-12, PEG-100 stearate, glyceryl stearate, perlite, beeswax, ammonium polyacryloyldimethyl taurate, phenoxyethanol, PEG-8 laurate, behenyl alcohol, sodium stearoyl glutamate, chlorphenesin, p-anisic acid, xanthan gum, tocopherol, disodium EDTA, arachidyl alcohol, diethylhexyl syringylidenemalonate, propylene glycol, cassia alata leaf extract, maltodextrin, stearyl alcohol, t-butyl alcohol, caprylic/capric triglyceride

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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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of 3 mL tubeimage of 3 mL tubeimage of 3 mL tubeimage of 3 mL tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of 90 mL tubeimage of 90 mL tubeimage of 90 mL tubeimage of 90 mL tube

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-994-01La Roche Posay Laboratoire Dermatologique Anthelios 60 Breakout Free Oil Free Face Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes50 mL in 1 BOTTLELOTION506
49967-994-01La Roche Posay Laboratoire Dermatologique Anthelios 60 Breakout Free Oil Free Face Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes1 in 1 CARTONLOTION16
49967-994-02La Roche Posay Laboratoire Dermatologique Anthelios 60 Breakout Free Oil Free Face Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes3 mL in 1 PACKETLOTION36
49967-994-03La Roche Posay Laboratoire Dermatologique Anthelios 60 Breakout Free Oil Free Face Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes1 in 1 CARTONLOTION16
49967-994-03La Roche Posay Laboratoire Dermatologique Anthelios 60 Breakout Free Oil Free Face Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes50 mL in 1 TUBELOTION506
49967-994-04La Roche Posay Laboratoire Dermatologique Anthelios 60 Breakout Free Oil Free Face Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes3 mL in 1 TUBELOTION36
49967-994-05La Roche Posay Laboratoire Dermatologique Anthelios 60 Breakout Free Oil Free Face Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes90 mL in 1 TUBELOTION906

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-99449967-994-01, 49967-994-02, 49967-994-03, 49967-994-04, 49967-994-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
NYLON-12446U8J075BIACT
PEG-100 STEARATEYD01N1999RIACT
PERLITE0SG101ZGK9IACT
PHENOXYETHANOLHIE492ZZ3TIACT
PEG-8 LAURATE762O8IWA10IACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
CHLORPHENESINI670DAL4SZIACT
P-ANISIC ACID4SB6Y7DMM3IACT
XANTHAN GUMTTV12P4NEEIACT
TOCOPHEROLR0ZB2556P8IACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
MALTODEXTRIN7CVR7L4A2DIACT
STEARYL ALCOHOL2KR89I4H1YIACT

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 Breakout Free Oil Free Face Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc06f2ced8-273e-454f-92b4-2846f6674b372025-07-10WarningsExact identifier
ndc (package): 49967-994-01
ndc (package): 49967-994-02
ndc (package): 49967-994-05
ndc (package): 49967-994-03
ndc (package): 49967-994-04
ndc (product): 49967-994
ndc11 (package): 49967099403
ndc11 (package): 49967099402
ndc11 (package): 49967099404
ndc11 (package): 49967099405
ndc11 (package): 49967099401
spl id: f675b238-84d1-4eb9-b874-78c81ab0173c
spl set id: 06f2ced8-273e-454f-92b4-2846f6674b37

Reported adverse events (FAERS/openFDA)#

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