FDA.reportPublic FDA data

La Roche Posay Laboratoire Dermatologique Toleriane Double Repair Moisturizer UV Broad Spectrum SPF 30 Sunscreen

Product NDC
49967-584
11-digit product format
499670584
Labeler code
49967
Product ID
49967-584_1e3bc0f0-d0c5-475a-8793-300736f9e6bd
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate and Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
L�Oreal USA Products Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-12-21
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30; 50; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49967-58449967-584-01DDiscontinued by firm2026-10-23
excluded packagepackage49967-58449967-584-05DDiscontinued by firm2026-10-23

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
La Roche Posay Laboratoire Dermatologique Toleriane Double Repair Moisturizer UV Broad Spectrum SPF 30 Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE50 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE70 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
be03b588-afbd-41d1-be96-444d735c9768Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-584-01La Roche Posay Laboratoire Dermatologique Toleriane Double Repair Moisturizer UV Broad Spectrum SPF 30 Sunscreen75 mL in 1 BOTTLELOTION7514
49967-584-01La Roche Posay Laboratoire Dermatologique Toleriane Double Repair Moisturizer UV Broad Spectrum SPF 30 Sunscreen1 in 1 CARTONLOTION114
49967-584-02La Roche Posay Laboratoire Dermatologique Toleriane Double Repair Moisturizer UV Broad Spectrum SPF 30 Sunscreen2 mL in 1 PACKETLOTION214
49967-584-03La Roche Posay Laboratoire Dermatologique Toleriane Double Repair Moisturizer UV Broad Spectrum SPF 30 Sunscreen3 mL in 1 TUBELOTION314
49967-584-04La Roche Posay Laboratoire Dermatologique Toleriane Double Repair Moisturizer UV Broad Spectrum SPF 30 Sunscreen1 in 1 CARTONLOTION114
49967-584-04La Roche Posay Laboratoire Dermatologique Toleriane Double Repair Moisturizer UV Broad Spectrum SPF 30 Sunscreen100 mL in 1 TUBELOTION10014
49967-584-05La Roche Posay Laboratoire Dermatologique Toleriane Double Repair Moisturizer UV Broad Spectrum SPF 30 Sunscreen1 in 1 CARTONLOTION114
49967-584-05La Roche Posay Laboratoire Dermatologique Toleriane Double Repair Moisturizer UV Broad Spectrum SPF 30 Sunscreen75 mL in 1 TUBELOTION7514
49967-584-06La Roche Posay Laboratoire Dermatologique Toleriane Double Repair Moisturizer UV Broad Spectrum SPF 30 Sunscreen1 in 1 CARTONLOTION114
49967-584-06La Roche Posay Laboratoire Dermatologique Toleriane Double Repair Moisturizer UV Broad Spectrum SPF 30 Sunscreen40 mL in 1 TUBELOTION4014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-584LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE TOLERIANE DOUBLE REPAIR MOISTURIZER UV BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) LOTION [L’OREAL USA PRODUCTS INC]12Current NDC, Legacy NDC, 10 package rows20240404_be03b588-afbd-41d1-be96-444d735c9768.zip

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 65 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHISEIDO URBAN ENVIRONMENT VITA-CLEAR SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION60e55ebb-47b8-465e-819a-af195952e1ca2026-02-04WarningsExact identifier
application number: M020
SHISEIDO BENEFIANCE NUTRIPERFECT DAYAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONf644c67b-3a71-411b-b321-39a8b18af0c72026-02-04WarningsExact identifier
application number: M020
cle de peau BEAUTE UV PROTECTIVE NAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporation4b242b76-8aed-4939-9906-741828acd8152026-02-04WarningsExact identifier
application number: M020
cle de peau BEAUTE PORE-REFINING MATTIFYING VEILAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporationefcf240f-95cb-45e0-b58a-9c8f3609aa552026-02-04WarningsExact identifier
application number: M020
cle de peau BEAUTE PORE-REFINING MATTIFYING VEILAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporation270ecc83-4262-4102-a753-2acaf11360a02026-02-04WarningsExact identifier
application number: M020
Walgreens 50 Caramel and Pistachio Scented SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY4a038017-9f15-b4b2-e063-6294a90a1b232026-02-04WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTOROCTISALATE, OCTOCRYLENE, ZINC OXIDEShiseido Americas Corporationce6a28c1-56e6-4105-bc9d-9d1986ead4202026-02-04WarningsExact identifier
application number: M020
Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEHARRIS TEETERd52e2c61-edbc-4c26-b1a7-e8eb656db1882026-02-04Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEHARRIS TEETERd365ed6d-a92f-473b-be19-b8b63d17f3b72026-02-04Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEHARRIS TEETER0a3b4597-06fe-4689-9751-6577867d755e2026-02-04Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEHARRIS TEETERb83ea476-fa32-4405-9ae3-f294836edb622026-02-04WarningsExact identifier
application number: M020
Sunplus SPF50 Face Body SunscreenSUNSCREENI.Shay Cosmetics26d55baf-66dc-b1b8-e063-6394a90a670d2026-02-04WarningsExact identifier
application number: M020
NUDESCREEN DEWY ILLUMINATING GLOW SPF 30 - Angel GlowZINC OXIDE SUNSCREENBentley Laboratories, LLC351217c4-8d71-41d9-ab08-c43857c0510c2026-02-04WarningsExact identifier
application number: M020
NIDA Invisible Fit Sun StickSUN STICKProso Corp49eca4f2-aae3-a0d5-e063-6394a90ab25f2026-02-03WarningsExact identifier
application number: M020
Shiny Hiny SPF 45 Mineral SunscreenZINC OXIDEShiny Hiny Products, LLC31adde36-5e1b-40ff-e063-6294a90a6f2e2026-02-03WarningsExact identifier
application number: M020
Walgreens 50 Passion Fruit Scented SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY49f030d8-959c-a3cd-e063-6294a90ae1ba2026-02-03WarningsExact identifier
application number: M020
Zealios Mineral SPF 30 SunscreenZINC OXIDEPersonal Best Products Inc. dba Zealiosc421b00c-6536-4455-81f6-01686f8c23882026-02-03WarningsExact identifier
application number: M020
Zealios Sport Performance Ultralight SPF 50 SunscreenHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEPersonal Best Products Inc. dba Zealios020bd1b4-da50-4117-a4f3-b74aa41873962026-02-03WarningsExact identifier
application number: M020
Adrien Arpel Daily Defense Moisturizer SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEColor Me Beautiful Incf65e1428-b79a-4126-862a-907ca17ee8f72026-02-02WarningsExact identifier
application number: M020
Flori Roberts Daily Defense Moisturizer SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEColor Me Beautiful Inc934d6b80-0cc3-4dcd-a25d-2191bd2736182026-02-02WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49967-584-01499670584011 BOTTLE in 1 CARTON (49967-584-01) > 75 mL in 1 BOTTLE1 bottle2016-12-210000-00-00NoNoCurrent
49967-584-02499670584022 mL in 1 PACKET (49967-584-02) 2 ml2016-12-210000-00-00NoNoCurrent
49967-584-03499670584033 mL in 1 TUBE (49967-584-03) 3 ml2016-12-210000-00-00NoNoCurrent
49967-584-04499670584041 TUBE in 1 CARTON (49967-584-04) / 100 mL in 1 TUBE1 tube2022-12-120000-00-00NoNoCurrent
49967-584-05499670584051 TUBE in 1 CARTON (49967-584-05) > 75 mL in 1 TUBE1 tube2016-12-210000-00-00NoNoCurrent
49967-584-06499670584061 TUBE in 1 CARTON (49967-584-06) / 40 mL in 1 TUBE1 tube2024-01-01NoNoCurrent