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Drug Facts

Manufacturer
Cosmetique Active Production | Socoplan
Effective date
2024-04-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:10:54

Label at a glance#

ProductLa Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen
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: ● shake well ● apply liberally 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 or higher and other sun protection measures inclu...

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 5%

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:
● shake well

● apply liberally 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 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, glycerin, silica, dimethicone, niacinamide, PEG-100 stearate, glyceryl stearate, stearic acid, allantoin, ceramide 3, dimethicone/vinyl dimethicone crosspolymer, sodium hydroxide, myristic acid, myristyl alcohol, palmitic acid, ammonium polyacryloyldimethyl taurate, disodium EDTA, capryloyl glycine, caprylyl glycol, citric acid, xanthan gum, t-butyl alcohol, cetyl alcohol, tocopherol

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 of a cartonimage of a carton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69625-583-01La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen75 mL in 1 BOTTLELOTION753
69625-583-01La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen1 in 1 CARTONLOTION13
69625-583-02La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen2 mL in 1 PACKETLOTION23
69625-583-03La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen3 mL in 1 TUBELOTION33
69625-583-04La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen100 mL in 1 TUBELOTION1003
69625-583-04La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen1 in 1 CARTONLOTION13
69625-583-05La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen1 in 1 CARTONLOTION13
69625-583-05La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen75 mL in 1 TUBELOTION753
69625-583-06La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen1 in 1 CARTONLOTION13
69625-583-06La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen40 mL in 1 TUBELOTION403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69625-583LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE TOLERIANE DOUBLE REPAIR UV BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) LOTION [COSMETIQUE ACTIVE PRODUCTION]3Current NDC, 10 package rows20240410_f9645435-e138-45df-a5ec-6dc7b3ff792d.zip

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
69625-58369625-583-01, 69625-583-02, 69625-583-03, 69625-583-04, 69625-583-05, 69625-583-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DIMETHICONE92RU3N3Y1OIACT
NIACINAMIDE25X51I8RD4IACT
PEG-100 STEARATEYD01N1999RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
STEARIC ACID4ELV7Z65APIACT
STEARYL ALCOHOL2KR89I4H1YIACT
ALLANTOIN344S277G0ZIACT
CERAMIDE 34370DF050BIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
SODIUM HYDROXIDE55X04QC32IIACT
MYRISTIC ACID0I3V7S25AWIACT
MYRISTYL ALCOHOLV42034O9PUIACT
PALMITIC ACID2V16EO95H1IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
CAPRYLOYL GLYCINE8TY5YO42NJIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
XANTHAN GUMTTV12P4NEEIACT
TERT-BUTYL ALCOHOLMD83SFE959IACT
CETYL ALCOHOL936JST6JCNIACT
TOCOPHEROLR0ZB2556P8IACT

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 Toleriane Double Repair UV Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENECosmetique Active Productionf9645435-e138-45df-a5ec-6dc7b3ff792d2024-04-08WarningsExact identifier
ndc (package): 69625-583-04
ndc (package): 69625-583-05
ndc (package): 69625-583-06
ndc (package): 69625-583-02
ndc (package): 69625-583-03
ndc (package): 69625-583-01
ndc (product): 69625-583
ndc11 (package): 69625058305
ndc11 (package): 69625058301
ndc11 (package): 69625058304
ndc11 (package): 69625058302
ndc11 (package): 69625058303
ndc11 (package): 69625058306
spl id: ac7275a0-234a-4918-befd-5e2a0d6c1133
spl set id: f9645435-e138-45df-a5ec-6dc7b3ff792d

Reported adverse events (FAERS/openFDA)#

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