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Drug Facts

Manufacturer
L'Oreal USA Products Inc | L'Oreal USA, Inc.
Effective date
2024-01-01
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:06:20

Label at a glance#

ProductLa Roche Posay Laboratoire Dermatologique Anthelios Kids Gentle Broad Spectrum SPF 50 Sunscreen for Face and Body Wat...
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, 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 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 13%

Octisalate 5%

Octocrylene 10%

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, glycerin, styrene/acrylates copolymer, poly c10-30 alkyl acrylate, polymethylsilsesquioxane, acrylates/dimethicone copolymer, niacinamide, silica, caprylyl methicone, acrylates/c10-30 alkyl acrylate crosspolymer, caprylic/capric triglyceride, caprylyl glycol, chlorphenesin, diethylhexyl syringylidenemalonate, glyceryl stearate, inulin lauryl carbamate, p-anisic acid, panthenol, PEG-100 stearate, PEG-8 laurate, phenoxyethanol, potassium cetyl phosphate, sodium dodecylbenzenesulfonate, sodium hyaluronate, tocopherol, triethanolamine, trisodium ethylenediamine disuccinate, xanthan gum

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
49967-603-01La Roche Posay Laboratoire Dermatologique Anthelios Kids Gentle Broad Spectrum SPF 50 Sunscreen for Face and Body Water Resistant 80 Minutes200 mL in 1 TUBELOTION2007
49967-603-02La Roche Posay Laboratoire Dermatologique Anthelios Kids Gentle Broad Spectrum SPF 50 Sunscreen for Face and Body Water Resistant 80 Minutes5 mL in 1 TUBELOTION57
49967-603-03La Roche Posay Laboratoire Dermatologique Anthelios Kids Gentle Broad Spectrum SPF 50 Sunscreen for Face and Body Water Resistant 80 Minutes2 mL in 1 PACKETLOTION27
49967-603-04La Roche Posay Laboratoire Dermatologique Anthelios Kids Gentle Broad Spectrum SPF 50 Sunscreen for Face and Body Water Resistant 80 Minutes1 in 1 CARTONLOTION17
49967-603-04La Roche Posay Laboratoire Dermatologique Anthelios Kids Gentle Broad Spectrum SPF 50 Sunscreen for Face and Body Water Resistant 80 Minutes15 mL in 1 TUBELOTION157
49967-603-05La Roche Posay Laboratoire Dermatologique Anthelios Kids Gentle Broad Spectrum SPF 50 Sunscreen for Face and Body Water Resistant 80 Minutes90 mL in 1 TUBELOTION907
49967-603-05La Roche Posay Laboratoire Dermatologique Anthelios Kids Gentle Broad Spectrum SPF 50 Sunscreen for Face and Body Water Resistant 80 Minutes1 in 1 CARTONLOTION17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-603LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS KIDS GENTLE BROAD SPECTRUM SPF 50 SUNSCREEN FOR FACE AND BODY WATER RESISTANT 80 MINUTES (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) LOTION [L'OREAL USA PRODUCTS INC]7Current NDC, Legacy NDC, 7 package rows20240102_8a2fd46c-5767-4621-8e69-dd291f9fe5b1.zip

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-60349967-603-01, 49967-603-02, 49967-603-03, 49967-603-04, 49967-603-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
CYCLOMETHICONE 6XHK3U310BAIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
NIACINAMIDE25X51I8RD4IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CHLORPHENESINI670DAL4SZIACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
GLYCERYL DISTEARATE73071MW2KMIACT
INULIN LAURYL CARBAMATE48RFF58ESGIACT
P-ANISIC ACID4SB6Y7DMM3IACT
PANTHENOLWV9CM0O67ZIACT
PEG-100 STEARATEYD01N1999RIACT
PEG-8 LAURATE762O8IWA10IACT
PHENOXYETHANOLHIE492ZZ3TIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
SODIUM DODECYLBENZENESULFONATE554127163YIACT
HYALURONATE SODIUMYSE9PPT4THIACT
TOCOPHEROLR0ZB2556P8IACT
TROLAMINE9O3K93S3TKIACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
XANTHAN GUMTTV12P4NEEIACT

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 Kids Gentle Broad Spectrum SPF 50 Sunscreen for Face and Body Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc8a2fd46c-5767-4621-8e69-dd291f9fe5b12024-01-01WarningsExact identifier
ndc (package): 49967-603-03
ndc (package): 49967-603-05
ndc (package): 49967-603-04
ndc (package): 49967-603-02
ndc (package): 49967-603-01
ndc (product): 49967-603
ndc11 (package): 49967060304
ndc11 (package): 49967060301
ndc11 (package): 49967060305
ndc11 (package): 49967060303
ndc11 (package): 49967060302
spl id: d878b502-3836-4ab9-a216-3c0759b7ab11
spl set id: 8a2fd46c-5767-4621-8e69-dd291f9fe5b1

Reported adverse events (FAERS/openFDA)#

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