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Drug Facts

Manufacturer
L’Oreal USA Products Inc | L'OREAL USA PRODUCTS, INC.
Effective date
2025-06-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:06:08

Label at a glance#

ProductLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE TOLERAINE DOUBLE REPAIR MATTE MOISTURIZER UV BROAD SPECTRUM SPF 30 FOR OILY...
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure14 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 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, regulary use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:             ...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Octocrylene 7.2%

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 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, regulary 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 producct in this container from excessive heat and direct sun
  • store at 20°-25°C (68° to 77° F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

 water, glycerin, dimethicone, silica, niacinamide, glyceryl stearate, PEG-100 stearate, pentylene glycol, dicaprylyl carbonate, steareth-100, stearic acid, ceramide NP, dimethicone/vinyl dimethicone crosspolymer, myristic acid, perlite, palmitic acid, ammonium polyacryloyldimethyl taurate, capryloyl salicylic acid, caprylyl glycol, citric acid, trisodium ethylenediamine disuccinate, xanthan gum, tocopherol, phenoxyethanol

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-387-01LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE TOLERAINE DOUBLE REPAIR MATTE MOISTURIZER UV BROAD SPECTRUM SPF 30 FOR OILY, COMBINATION SKIN100 mL in 1 TUBECREAM1001
49967-387-01LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE TOLERAINE DOUBLE REPAIR MATTE MOISTURIZER UV BROAD SPECTRUM SPF 30 FOR OILY, COMBINATION SKIN1 in 1 CARTONCREAM11

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-38749967-387-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE92RU3N3Y1OIACT
SILICAETJ7Z6XBU4IACT
NIACINAMIDE25X51I8RD4IACT
GLYCERYL STEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
PENTYLENE GLYCOL50C1307PZGIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
STEARETH-1004OH5W9UM87IACT
STEARIC ACID4ELV7Z65APIACT
CERAMIDE NP4370DF050BIACT
MYRISTIC ACID0I3V7S25AWIACT
PERLITE0SG101ZGK9IACT
PALMITIC ACID2V16EO95H1IACT
AMMONIUM POLYACRYLOYLDIMETHYL TAURATEF01RIY4371IACT
CAPRYLOYL SALICYLIC ACID5F7PJF6AA4IACT
CAPRYLYL GLYCOL00YIU5438UIACT
CITRIC ACID2968PHW8QPIACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
XANTHAN GUMTTV12P4NEEIACT
TOCOPHEROLR0ZB2556P8IACT
PHENOXYETHANOLHIE492ZZ3TIACT

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 TOLERAINE DOUBLE REPAIR MATTE MOISTURIZER UV BROAD SPECTRUM SPF 30 FOR OILY, COMBINATION SKINAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inca3dc6195-3011-4e7f-b1b0-0c815b11ba8d2025-06-30WarningsExact identifier
ndc (package): 49967-387-01
ndc (product): 49967-387
ndc11 (package): 49967038701
spl id: a7e8b9d4-c17e-4c0b-9604-1ea4b026c516
spl set id: a3dc6195-3011-4e7f-b1b0-0c815b11ba8d

Reported adverse events (FAERS/openFDA)#

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