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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 69625-583 | 69625-583-01 | D | Discontinued by firm | 2026-10-27 | |
| excluded package | package | 69625-583 | 69625-583-05 | D | Discontinued by firm | 2026-10-27 |
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.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 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 |
|---|---|
| AVOBENZONE | 30 mg/mL |
| HOMOSALATE | 50 mg/mL |
| OCTISALATE | 50 mg/mL |
| OCTOCRYLENE | 70 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| G63QQF2NOX | Internal UNII lookup |
| V06SV4M95S | Internal UNII lookup |
| 4X49Y0596W | Internal UNII lookup |
| 5A68WGF6WM | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f9645435-e138-45df-a5ec-6dc7b3ff792d | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69625-583-01 | La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen | 75 mL in 1 BOTTLE | LOTION | 75 | 3 | |
| 69625-583-01 | La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen | 1 in 1 CARTON | LOTION | 1 | 3 | |
| 69625-583-02 | La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen | 2 mL in 1 PACKET | LOTION | 2 | 3 | |
| 69625-583-03 | La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen | 3 mL in 1 TUBE | LOTION | 3 | 3 | |
| 69625-583-04 | La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen | 100 mL in 1 TUBE | LOTION | 100 | 3 | |
| 69625-583-04 | La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen | 1 in 1 CARTON | LOTION | 1 | 3 | |
| 69625-583-05 | La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen | 1 in 1 CARTON | LOTION | 1 | 3 | |
| 69625-583-05 | La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen | 75 mL in 1 TUBE | LOTION | 75 | 3 | |
| 69625-583-06 | La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen | 1 in 1 CARTON | LOTION | 1 | 3 | |
| 69625-583-06 | La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen | 40 mL in 1 TUBE | LOTION | 40 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69625-583 | LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE TOLERIANE DOUBLE REPAIR UV BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) LOTION [COSMETIQUE ACTIVE PRODUCTION] | 3 | Current NDC, 10 package rows | 20240410_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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Expedition BackCountry SPF 30 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b5e4e63c-3e51-0a78-e053-2a95a90abd87 | 2025-11-04 | Warnings | M020 |
| Reef Babies SPF 50 Oxybenzone Free | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | 8cd68b09-2578-4519-b00e-e83e0e440815 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b5e44be7-3a46-34e2-e053-2a95a90a9660 | 2025-11-04 | Warnings | M020 |
| Reef Kids SPF 30 Oxybenzone Free | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | 005a9e7c-e392-4b9a-911f-d7586f7ae94e | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 | OCTOCRYLENE, OCTISALATE, AVOBENZONE | Tropical Seas, Inc. | b559d349-2ffd-492c-e053-2995a90aab06 | 2025-11-04 | Warnings | M020 |
| Land Shark Zinky SPF 36 Pink Beach | ZINC OXIDE | Tropical Seas, Inc. | d240e6c9-d053-9924-e053-2a95a90a855a | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 15 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b5e49c6f-477b-aafc-e053-2a95a90a982a | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 | OCTOCRYLENE, OCTISALATE, AVOBENZONE | Tropical Seas, Inc. | b559e03b-f5d3-bd72-e053-2995a90a31ca | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 Clear Zinc | ZINC OXIDE AND TITANIUM DIOXIDE | Tropical Seas, Inc. | d128269b-73fa-e5f3-e053-2995a90af1ed | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 50 Sport | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b5e40a7c-b49d-cfc3-e053-2995a90ac27e | 2025-11-04 | Warnings | M020 |
| Reef Babies SPF 50 Oxybenzone Free | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | d5ed3488-aa32-4a63-9996-12c6532c3a4d | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 | OCTOCRYLENE, OCTISALATE, AVOBENZONE | Tropical Seas, Inc. | b559499c-6109-bf5e-e053-2995a90a4ac7 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 50 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b5e24ca1-d041-355d-e053-2995a90a3d61 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b5570cbd-89f5-65d5-e053-2995a90a54d1 | 2025-11-04 | Warnings | M020 |
| Land Shark Zinky SPF 36 Azure Blue | ZINC OXIDE | Tropical Seas, Inc. | d23fe61a-3ffb-59d0-e053-2995a90a59e6 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 | OCTOCRYLENE, OCTISALATE, AVOBENZONE | Tropical Seas, Inc. | b55a0bd0-2a32-2977-e053-2a95a90aa142 | 2025-11-04 | Warnings | M020 |
| Expedition BackCountry SPF 30 | OCTOCRYLENE, OCTISALATE, AVOBENZONE | Tropical Seas, Inc. | 06d43525-86d8-f2d9-e063-6394a90afc81 | 2025-11-04 | Warnings | M020 |
| Land Shark Zinky SPF 36 Pacific Purple | ZINC OXIDE | Tropical Seas, Inc. | d240fe7c-9d16-78c9-e053-2a95a90a763c | 2025-11-04 | Warnings | M020 |
| Expedition BackCountry SPF 50 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | 06c1ac52-474c-db5c-e063-6294a90afb5f | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 Tinted Zinc | ZINC OXIDE AND TITANIUM DIOXIDE | Tropical Seas, Inc. | d1287899-f178-6124-e053-2a95a90a95a5 | 2025-11-04 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 69625-583-01 | 69625058301 | 75 mL in 1 BOTTLE | 75 ml | Historical | |||
| 69625-583-02 | 69625058302 | 2 mL in 1 PACKET (69625-583-02) | 2 ml | 2016-12-21 | No | No | Current |
| 69625-583-03 | 69625058303 | 3 mL in 1 TUBE (69625-583-03) | 3 ml | 2016-12-21 | No | No | Current |
| 69625-583-04 | 69625058304 | 1 TUBE in 1 CARTON (69625-583-04) / 100 mL in 1 TUBE | 1 tube | 2022-12-12 | No | No | Current |
| 69625-583-05 | 69625058305 | 1 in 1 CARTON | Historical | ||||
| 69625-583-06 | 69625058306 | 1 TUBE in 1 CARTON (69625-583-06) / 40 mL in 1 TUBE | 1 tube | 2024-01-01 | No | No | Current |