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 firm2026-10-27
excluded packagepackage49967-58449967-584-05DDiscontinued by firm2026-10-27

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 98 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eucerin Face immersive HydrationAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Incfe0b3717-f472-3a61-e053-6394a90a44fb2025-12-31WarningsExact identifier
application number: M020
NIVEA MEN Age Defense Face MoisturizerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inc27cbec3e-e811-6498-e063-6394a90ada492025-12-31WarningsExact identifier
application number: M020
Nivea Men Maximum Hydration FaceAVOBENZONE, OCTISALATE, OCTOCRYLENEBeiersdorf Incf1276b11-6683-e982-e053-2a95a90a78032025-12-31WarningsExact identifier
application number: M020
Nivea Men Sensitive ProtectiveAVOBENZONE, OCTISALATE, OCTOCRYLENEBeiersdorf Incf6cff3d1-cca5-4b3e-a481-0c4def90684c2025-12-31WarningsExact identifier
application number: M020
Nivea Smoothness Lip CareAVOBENZONE,OCTOCRYLENEBeiersdorf Incc28e327d-ad39-9bd6-e053-2a95a90a04eb2025-12-31WarningsExact identifier
application number: M020
BOTANICAL SOOTHING SPF-30OCTINOXATE, OCTISALATE, ZINC OXIDECONTROL CORRECTIVE SKINCARE INC00a923fe-e6da-420e-a705-4773ecc2176b2025-12-31WarningsExact identifier
application number: M020
AROMA MATTE DAY SUNSCREEN SPF-30OCTINOXATE, OCTISALATE, ZINC OXIDECONTROL CORRECTIVE SKINCARE INCf822f3ec-3c57-100a-e053-6294a90ab0ec2025-12-31WarningsExact identifier
application number: M020
CONTROL CORRECTIVE TINTED MOISTURIZER SPF-30 SUNSCREENTITANIUM DIOXIDE, ZINC OXIDECONTROL CORRECTIVE SKINCARE INC8ac09149-f7e7-40a8-b306-98964d0cd6e32025-12-31WarningsExact identifier
application number: M020
CONTROL CORRECTIVE SUNSCREEN SPF-30OCTINOXATE, OCTISALATE, ZINC OXIDECONTROL CORRECTIVE SKINCARE INCe389b2bc-bb1c-443a-9bf6-c6d96380f3782025-12-31WarningsExact identifier
application number: M020
CONTROL CORRECTIVE INTENSIVE SKIN BRIGHTENING SPF-30 SUNSCREENOCTINOXATE, OCTISALATE, ZINC OXIDECONTROL CORRECTIVE SKINCARE INC61b6dab9-3378-4206-bf1f-6f385a9c882c2025-12-31WarningsExact identifier
application number: M020
Blue Lizard Sensitive SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories32d78048-d281-1d80-e063-6394a90aec192025-12-31WarningsExact identifier
application number: M020
DAYWEAR ANTI OXIDANT 72H-HYDRATION SORBET CREME BROAD SPECTRUM SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEESTEE LAUDER INCdf535004-c94c-4a28-ad20-78bd1741e39f2025-12-31WarningsExact identifier
application number: M020
FUTURIST SKIN TINT SERUMOCTINOXATE,OCTISALATE,ZINC OXIDEESTEE LAUDER INCea21e5a5-69d6-2de4-e053-2995a90a93b42025-12-31WarningsExact identifier
application number: M020
Dr.Jart Cicapair Tiger Grass Color Correcting TreatmentZINC OXIDE, TITANIUM DIOXIDEHave & Be Co., Ltd.40f96baf-0359-4d68-801f-68562c9094462025-12-31WarningsExact identifier
application number: M020
Dr.Jart Premium Beauty Balm Fair-LightZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.b38b1b64-b433-4e11-9cf6-2108a552d1392025-12-31WarningsExact identifier
application number: M020
Dr.Jart Premium Beauty Balm Light Medium-MediumZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.45b1c2c6-a45b-4a45-bec9-e5341079c0a12025-12-31WarningsExact identifier
application number: M020
Dr.Jart Premium Beauty Balm Medium-TanZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.28a2ba45-1eff-488c-aae4-362b9f78b8df2025-12-31WarningsExact identifier
application number: M020
Dr.Jart Premium Beauty Balm Deep Tan-DeepZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.3c346960-b76b-4241-a188-8ee6948530782025-12-31WarningsExact identifier
application number: M020
DR.JART CICAPAIR TIGER GRASS CAMO DROPSZINC OXIDE, TITANIUM DIOXIDEHave & Be Co., Ltd.f06348f5-4ebc-325b-e053-2a95a90ada522025-12-31WarningsExact identifier
application number: M020
DR.JART EVERY SUN DAY MINERAL SUN SCREENTITANIUM DIOXIDE, ZINC OXIDEHave & Be Co., Ltd.f06c31b4-da5f-6495-e053-2995a90ae67c2025-12-31WarningsExact 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