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 | 2026-10-23 | |
| excluded package | package | 69625-583 | 69625-583-05 | D | Discontinued by firm | 2026-10-23 |
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.
| 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 |
|---|---|---|---|---|---|---|
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21N PACK OF 2 | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 3483e4fa-883b-fb9c-e063-6394a90adcc4 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23W PACK OF 2 | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 3483dd31-417b-01ba-e063-6294a90a83a8 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27C PACK OF 2 | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 3483e998-6122-fb84-e063-6394a90a159f | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 28N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | c96e691a-99e1-4cb4-aebf-7444f4a6865f | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 33N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | ab1c8e9e-fd8f-473e-8930-625706e8e9d6 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 17073264-ec02-4801-841d-86778debd8c4 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 41N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | caee5c88-1907-41c1-987e-5bc544267dca | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 33W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 973b70f1-ee59-4dd9-aca3-432d721204ab | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 208fe03e-384b-4599-a4d0-a553fba306da | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 35N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 279258dd-b3fa-47be-8540-66bd9c879fc5 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 47N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | c2ad2a5e-f8fe-41b3-8b0f-9981c337ec5c | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 31N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 4206b607-5c26-4c9d-ade7-58c9740cdbe8 | 2025-12-09 | Warnings | M020 |
| L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 Medium | OCTOCRYLENE, ZINC OXIDE | L'BRI Health & Beauty | 949a2796-717c-4820-ae09-2636e3dd6e3d | 2025-12-09 | Warnings | M020 |
| L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 Medium Dark | OCTOCRYLENE, ZINC OXIDE | L'BRI Health & Beauty | f9bbc6d3-eb50-4953-8dba-732094b4c7c4 | 2025-12-09 | Warnings | M020 |
| Safe Sea SPF 50 | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | NIDARIA TECHNOLOGY LTD | 53df3126-1136-490a-b339-5876ce89499e | 2025-12-09 | Warnings | M020 |
| Safe Sea SPF 50 kids | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | NIDARIA TECHNOLOGY LTD | 3fa04557-2bc1-4eb4-aed8-eacc79189613 | 2025-12-09 | Warnings | M020 |
| Safe Sea SPF 40 | OCTOCRYLENE, HOMOSALATE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE | NIDARIA TECHNOLOGY LTD | c900b88b-1de1-4df9-af84-d9001e1d4764 | 2025-12-09 | Warnings | M020 |
| StriVectin ANTI-WRINKLE GLOWFECTOR SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | StriVectin Operating Company, Inc. | ed357e76-54a1-66bd-e053-2a95a90a1e2a | 2025-12-09 | Warnings | M020 |
| Non-tinted Physical Block Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Tucson Acne Clinic | 30dd2f6b-5dcc-b081-e063-6394a90ae5f1 | 2025-12-09 | Warnings | M020 |
| Tinted Physical Block Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Tucson Acne Clinic | 30dc6e23-ecca-ed0b-e063-6294a90a7951 | 2025-12-09 | 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 |