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Drug Facts

Manufacturer
L'Oreal USA Products Inc | Dimensional Merchandising Inc.
Effective date
2023-12-31
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:06:14

Label at a glance#

ProductLa Roche Posay Laboratoire Dermatologique Anthelios 50 Daily Antiaging Primer with Sunscreen
Active ingredientAvobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
Label structure13 sections

Indications and uses

helps prevent sunburn if used as directed (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 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 of higher and other sun protection measures including: limit time in t...

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 10%

Octisalate 5%

Octocrylene 5%

Oxybenzone 6%

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed (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 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 of 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

Purpose

OTC - PURPOSE SECTION

Sunscreen

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

dimethicone, C12-15 alkyl benzoate, talc, diisopropyl sebacate, silica, silica silylate, glycerin, trimethylsiloxysilicate, dimethicone crosspolymer, water, 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

image descriptionimage description

image description
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-095-01La Roche Posay Laboratoire Dermatologique Anthelios 50 Daily Antiaging Primer with Sunscreen40 mL in 1 TUBELOTION408
49967-095-01La Roche Posay Laboratoire Dermatologique Anthelios 50 Daily Antiaging Primer with Sunscreen1 in 1 CARTONLOTION18
49967-095-02La Roche Posay Laboratoire Dermatologique Anthelios 50 Daily Antiaging Primer with Sunscreen40 mL in 1 BOTTLELOTION408
49967-095-02La Roche Posay Laboratoire Dermatologique Anthelios 50 Daily Antiaging Primer with Sunscreen1 in 1 CARTONLOTION18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-095LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 DAILY ANTIAGING PRIMER WITH SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [L'OREAL USA PRODUCTS INC]8Current NDC, Legacy NDC, 4 package rows20240101_6b65d6d9-7ff3-4c84-986e-ef180161eadb.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOX1
HomosalateACTIVE INGREDIENTV06SV4M95S1
OctisalateACTIVE INGREDIENT4X49Y0596W1
OctocryleneACTIVE INGREDIENT5A68WGF6WM1
OxybenzoneACTIVE INGREDIENT95OOS7VE0Y1
AvobenzoneACTIVE MOIETYG63QQF2NOX1
HomosalateACTIVE MOIETYV06SV4M95S1
OctisalateACTIVE MOIETY4X49Y0596W1
OctocryleneACTIVE MOIETY5A68WGF6WM1
OxybenzoneACTIVE MOIETY95OOS7VE0Y1

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-09549967-095-01, 49967-095-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
AvobenzoneG63QQF2NOXACTIB
HomosalateV06SV4M95SACTIB
Octisalate4X49Y0596WACTIB
Octocrylene5A68WGF6WMACTIB
Oxybenzone95OOS7VE0YACTIB
DIMETHICONE92RU3N3Y1OIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
TALC7SEV7J4R1UIACT
DIISOPROPYL SEBACATEJ8T3X564IHIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
GLYCERINPDC6A3C0OXIACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)5041RX63GNIACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
WATER059QF0KO0RIACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
SENNA ALATA LEAF4BXR6YZN92IACT
MALTODEXTRIN7CVR7L4A2DIACT

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 50 Daily Antiaging Primer with SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONEL'Oreal USA Products Inc6b65d6d9-7ff3-4c84-986e-ef180161eadb2023-12-31WarningsExact identifier
ndc (package): 49967-095-01
ndc (package): 49967-095-02
ndc (product): 49967-095
ndc11 (package): 49967009501
ndc11 (package): 49967009502
spl id: 360ef510-bc5d-4ad0-ad74-1b482451898c
spl set id: 6b65d6d9-7ff3-4c84-986e-ef180161eadb

Reported adverse events (FAERS/openFDA)#

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