Drug Facts

Manufacturer
L'Oreal USA Products Inc | Cosmetique Active Production
Effective date
2023-10-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:56:55

Label at a glance#

ProductLa Roche Posay Laboratoire Dermatologique Mela B3 UV Daily Sunscreen Broad Spectrum SPF 30
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 at least every 2 hours use a water resistat 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 or higher and other sun protection meausures including: limit time in...

Storage and handling

protect the product in this container from excessive heat and direct sun store at 20º - 25º C (68º - 77º F)

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%
Homosalate 10%
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 at least every 2 hours
  • use a water resistat 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 or higher and other sun protection meausures 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
  • store at 20º - 25º C (68º - 77º F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, c15-19 alkane, niacinamide, glycerin, butylene glycol, silica, titanium dioxide, butyrospermum parkii (shea) butter, tin oxide, potassium hydroxide, carbomer, arachidyl alcohol, arachidyl glucoside, behenyl alcohol, 2-mercaptonicotinoyl glycine, sodium dilauramidoglutamide lysine, sodium thiosulfate, ammonium acryloyldimethyltaurate/VP copolymer, hydroxyacetophenone, capryloyl salicylic acid, caprylyl glycol, citric acid, trisodium ethylenediamine disuccinate, xanthan gum, pentylene glycol, poly c10-30 alkyl acrylate, polyglyceryl-4 caprate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, red 4, mica, fragrance

Questions or comments?

OTC - QUESTIONS SECTION

1-888-577-5226   1-888-LRP LABO

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5Product name120150828

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-113-01La Roche Posay Laboratoire Dermatologique Mela B3 UV Daily Sunscreen Broad Spectrum SPF 301 in 1 CARTONLOTION12
49967-113-01La Roche Posay Laboratoire Dermatologique Mela B3 UV Daily Sunscreen Broad Spectrum SPF 3040 mL in 1 TUBELOTION402
49967-113-02La Roche Posay Laboratoire Dermatologique Mela B3 UV Daily Sunscreen Broad Spectrum SPF 303 mL in 1 TUBELOTION32
49967-113-02La Roche Posay Laboratoire Dermatologique Mela B3 UV Daily Sunscreen Broad Spectrum SPF 301 in 1 CARTONLOTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-113LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE MELA B3 UV DAILY SUNSCREEN BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) LOTION [L'OREAL USA PRODUCTS INC]2Current NDC, 4 package rows20231019_8d1c89b2-55f4-4d49-a4c2-bb0aa220ff1d.zip

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-11349967-113-01, 49967-113-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 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 Mela B3 UV Daily Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc8d1c89b2-55f4-4d49-a4c2-bb0aa220ff1d2023-10-18WarningsExact identifier
ndc (package): 49967-113-01
ndc (package): 49967-113-02
ndc (product): 49967-113
ndc11 (package): 49967011301
ndc11 (package): 49967011302
spl id: 96ad9e71-c0b9-4917-8f2b-816290e881b0
spl set id: 8d1c89b2-55f4-4d49-a4c2-bb0aa220ff1d

Reported adverse events (FAERS/openFDA)#

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