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

Product NDC
69625-583
11-digit product format
696250583
Labeler code
69625
Product ID
69625-583_ac7275a0-234a-4918-befd-5e2a0d6c1133
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate and Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
Cosmetique Active Production
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
2026-12-31
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 packagepackage69625-58369625-583-01DDiscontinued by firm2026-10-20
excluded packagepackage69625-58369625-583-05DDiscontinued by firm2026-10-20

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 UV Broad Spectrum SPF 30 Sunscreen
Listing expiration
2026-12-31

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
f9645435-e138-45df-a5ec-6dc7b3ff792dAvailable on FDA.report

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

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 69 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALOE KOTE SPF 25OCTINOXATE, OXYBENZONE, HOMOSALATEAloe Care International, LLC12e78c53-ba19-4c8e-bd2f-8c85fccbc1792026-01-26WarningsExact identifier
application number: M020
ALOE UP KIDS SPORT SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC62016e94-b5d2-4ba2-ab9c-b0b2c1ead6502026-01-26WarningsExact identifier
application number: M020
Homosalate 10 Avobenzone 3% Octocrylene 6%SPF 45 FACES&C Hampton Sun LLCe49808c9-5025-4965-8679-7fe824cf69072026-01-26WarningsExact identifier
application number: M020
ENVIRONMENTAL DEFENSEZINC OXIDEAvasol LLC1fbddab4-71f7-4167-ad21-30040b7c71bb2026-01-26WarningsExact identifier
application number: M020
Surfers BarrierZINC OXIDEAvasol LLCd6e2ac0a-3bf6-4d08-8647-6a23de2ac8572026-01-26WarningsExact identifier
application number: M020
SURFERS BARRIER SPF 50ZINC OXIDE, TITANIUM DIOXIDEAvasol LLCec55eef0-17e6-416d-bd5e-548f2f323cea2026-01-26WarningsExact identifier
application number: M020
Zenskin Watery Dew Nia-Cica SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SUNSCREENZenskin Co. Ltd.49584899-d523-9677-e063-6394a90a14032026-01-26WarningsExact identifier
application number: M020
Caring mill sun serum with Vitamin C NiacinamideHOMOSALATE OCTOCRYLENE OCTISALATE AVOBENZONEFSA Store lnc.4931ee71-1088-1ac1-e063-6294a90ad82b2026-01-25WarningsExact identifier
application number: M020
Caring mill Mineral Eye CreamZINC OXIDEFSA STORE INC.4932ea19-28cc-b245-e063-6394a90ac7aa2026-01-25WarningsExact identifier
application number: M020
Ceile SPF 30 prime PROTECT Broad Spectrum SPF 30 SunscreenSUNSCREEN 30 MINERALLE COSMETICS INC2cee0413-d532-c192-e063-6294a90aa8232026-01-25WarningsExact identifier
application number: M020
BeginS by JUNGSAEMMOOL Blue Chamomile Hyaluronic Acid Aqua Sunscreen Broad Spectrum SPF 50 plusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEJungsaemmool Beauty Co., Ltd.62e23503-7233-434a-91f0-092f10d2717d2026-01-24WarningsExact identifier
application number: M020
BeginS by JUNGSAEMMOOL Blue Chamomile Hyaluronic Acid Airy Sun Stick Broad Spectrum SPF 50 plusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEJungsaemmool Beauty Co., Ltd.030a20fb-4846-4a5c-9808-a399aac2ff0b2026-01-24WarningsExact identifier
application number: M020
Mimosa Lane SPF45OCTINOXATE, OCTISALATE, ZINC OXIDE SUNSCREENR&G Divergency LLC40f3b8ea-bfa5-4c66-9c79-c4408bda857a2026-01-24WarningsExact identifier
application number: M020
111 SKIN SUNSCREEN SPF 50ZINC OXIDEBentley Laboratories, LLCb1265797-71dd-4302-ab26-dbff6ccec8562026-01-23WarningsExact identifier
application number: M020
Mania Holic Sunscreen PackOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEFirstmarket Co., ltd.b95a460c-1f7b-4193-b305-466e073af6402026-01-23WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 320HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.1cdbae71-441b-426d-99ee-c889d76af4522026-01-23WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 250HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.8f4b5e0a-4578-4af3-b7d9-a19d4eb732e72026-01-23WarningsExact identifier
application number: M020
ISA KNOX 365 BB SUNSCREEN Broad Spectrum SPF 40, PATITANIUM DIOXIDELG Household and Healthcare, Inc.65e70306-9e79-494d-9217-a43002f163072026-01-23WarningsExact identifier
application number: M020
O HUI Sun Science Ideal Cover Sunscreen Broad SpectrumTITANIUM DIOXIDELG Household and Healthcare, Inc.c15ffd23-271d-458d-9048-9bc50331d5d72026-01-23WarningsExact identifier
application number: M020
Aqua protection Sunscreen Broad Spectrum SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEENGLEWOOD LAB, INC.627e6ea5-016b-4ab6-a50c-aa9c27e5cca12026-01-23WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69625-583-016962505830175 mL in 1 BOTTLE75 mlHistorical
69625-583-02696250583022 mL in 1 PACKET (69625-583-02) 2 ml2016-12-21NoNoCurrent
69625-583-03696250583033 mL in 1 TUBE (69625-583-03) 3 ml2016-12-21NoNoCurrent
69625-583-04696250583041 TUBE in 1 CARTON (69625-583-04) / 100 mL in 1 TUBE1 tube2022-12-12NoNoCurrent
69625-583-05696250583051 in 1 CARTONHistorical
69625-583-06696250583061 TUBE in 1 CARTON (69625-583-06) / 40 mL in 1 TUBE1 tube2024-01-01NoNoCurrent