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 | 2026-11-13 | |
| excluded package | package | 69625-583 | 69625-583-05 | D | Discontinued by firm | 2026-11-13 |
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 |
|---|---|---|---|---|---|---|
| Smoothing Mineral Sunscreen Tinted | TITANIUM DIOXIDE, ZINC OXIDE | DANIEL BEHROOZAN MD A MEDICAL CORPORATION | 327246c2-9d7a-2d34-e063-6294a90a5fb7 | 2025-04-10 | M020 | |
| Clarity Rx Physical Skin Defense SPF 50 | ZINC OXIDE AND TITANIUM DIOXIDE | Topiderm, Inc. | b5111012-97b9-4908-95a0-d09595f9c4d9 | 2025-04-10 | Warnings | M020 |
| Tinted Mineral Sunscreen SPF 50 | ZINC OXIDE AND TITANIUM DIOXIDE | Topiderm, Inc. | 13e5085f-df2b-46b2-b063-e58ce4379905 | 2025-04-09 | Warnings | M020 |
| Sunstation Sport Sunscreen SPF 30 | OCTOCRYLENE, ZINC OXIDE, OCTISALATE | Sunstation USA LLC | 6007c125-f28a-45e5-b8f1-490ee04b7811 | 2025-04-09 | Warnings | M020 |
| Pacifica Sun Dreams Illuminating SPF Foam | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Pacifica Beauty, LLC | 2e0cb105-75c3-8032-e063-6394a90ab502 | 2025-04-09 | Warnings | M020 |
| belif Aqua bomb - glow sunstick SPF50 | HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE | LG H&H CO., LTD. | 284cadf1-deb9-4f3d-e063-6394a90ab122 | 2025-04-09 | Warnings | M020 |
| ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (ROSA ROMANTICA FEMME) - PINK | OCTINOXATE AND OXYBENZONE | Ventura Corporation LTD | aa79b1a4-6b33-47c9-b55e-b813d9b22265 | 2025-04-09 | Warnings | M020 |
| Brush On Block SPF 30 Mineral Powder Touch of Tan Zinc Only | ZINC OXIDE | SPF Ventures, LLC | 3240cbe5-bfc8-17f7-e063-6394a90a1b98 | 2025-04-08 | Warnings | M020 |
| ISA KNOX UV SUN PRO 365 Sheer Mineral Face | ZINC OXIDE | LG HOUSEHOLD & HEALTH CARE LTD. | 2eeac795-b74e-b3a3-e063-6294a90abf52 | 2025-04-08 | Warnings | M020 |
| The Face Shop Hydro Sun Barrier 2-in-1 SPF and Moisturizer | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | LG HOUSEHOLD & HEALTH CARE LTD. | 2ee9f271-b508-2304-e063-6294a90a3752 | 2025-04-08 | Warnings | M020 |
| CLARINS Multi-Active Jour Niacinamide and Sea Holly Extract Sunscreen SPF 15 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Laboratoires Clarins | a43d0d4f-94de-4c4b-a17a-63a819d5d293 | 2025-04-07 | Warnings | M020 |
| Gangnam Glow Sunscreen 50 | AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | LG HOUSEHOLD & HEALTH CARE LTD. | 30cc2e35-f752-8285-e063-6294a90afbf5 | 2025-04-07 | Warnings | M020 |
| Carmex Daily Care Moisturizing Lip Balm SPF 15 | OCTINOXATE, OXYBENZONE | Carma Laboratories, Inc. | 26f8dc88-2096-4fa1-81ae-ea92fe1f353d | 2025-04-07 | Warnings | M020 |
| Vacation Instant Browning | AVOBENZONE OCTISALATE OCTOCRYLENE | Vacation Inc. | 13028f61-3f62-22cc-e063-6394a90a6bf1 | 2025-04-04 | Warnings | M020 |
| LBri Pure n Natural SPF 30 | ZINC OXIDE | L'BRI HEALTH & BEAUTY | 8350791d-5cf2-4358-9f85-9384d35be9f4 | 2025-04-03 | Warnings | M020 |
| SHEER MINERAL SUNSCREEN | ZINC OXIDE | Plant Devas Inc. dba evanhealy | f620ef44-f30c-4cc9-bc82-28dc4a47a8da | 2025-04-02 | Warnings | M020 |
| CLEAR GLOW BROAD SPECTRUM SUNCREEN SPF 50 | AVOBENZONE, HOMOSALATE OCTISALATE, OCTOCRYLENE | NAKED SUNDAYS PTY LTD | 0116cffa-3415-746b-e063-6394a90ab3b3 | 2025-04-01 | Warnings | M020 |
| HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50 SPF 50 | AVOBENZONE, HOMOSALATE OCTISALATE, | NAKED SUNDAYS PTY LTD | 04293280-e74a-f293-e063-6394a90a06f6 | 2025-04-01 | Warnings | M020 |
| Glow Go Lip Oil | AVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G, | NAKED SUNDAY PTY LTD | e5aab267-b33b-a40d-e053-2a95a90a9d79 | 2025-04-01 | Warnings | M020 |
| Glow Go Lip Oil | AVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G, | NAKED SUNDAY PTY LTD | e5beb9cd-aa3b-2b37-e053-2995a90a8409 | 2025-04-01 | 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 |