Soleil Toujours
- Product NDC
- 58443-0555
- 11-digit product format
- 584430555
- Labeler code
- 58443
- Product ID
- 58443-0555_e6627a59-c59a-c1c9-e053-2a95a90ae506
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Avobenzone, Homosalate, Octisalate
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Prime Enterprises Inc.
- Application
- M020
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2017-02-20
- Marketing end
- 0000-00-00
- Substance
- AVOBENZONE; HOMOSALATE; OCTISALATE
- Active strength
- 25 mg/mL; mg/mL; mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 product | product | 58443-0555 | I | Inactivated by FDA | 2026-10-12 | ||
| excluded package | package | 58443-0555 | 58443-0555-3 | I | Inactivated by FDA | 2026-10-12 |
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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58443-0555-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 58443-0555-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 58443-0555-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 58443-0555-3 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 58443-0555-3 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 58443-0555-3 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 58443-0555-3 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 58443-0555-3 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 58443-0555-3 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 58443-0555-3 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 58443-0555-3 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 58443-0555-3 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 58443-0555-3 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 58443-0555-3 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 58443-0555-3 | 1332a3947898… | d4bfe170f9cd… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58443-0555-3 | 2024-01-30 | C162847 | 48780-1 | 1030e365-6dbb-111a-e063-dadaa90a10e2 | Soleil Toujors Set + Protect Micro Mist Broad Spectrum SPF 30 Sunscreen |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58443-0555-3 | Soleil ToujoursBroad Spectrum SPF 30 Sunscreen | 59 mL in 1 TUBE | LOTION | 59 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58443-0555 | SOLEIL TOUJOURS BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE) LOTION [PRIME ENTERPRISES INC.] | 1 | Legacy NDC, 1 package rows | 20220818_e6629504-b211-4cd1-e053-2a95a90a2826.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 |
|---|---|---|---|---|---|---|
| Bath and Body Works SPF Coconut | AVOBENZONE,HOMOSALATE,OCTISALATE | Bath & Body Works, Inc. | 56078491-f7d6-97f7-e063-6394a90a6deb | 2026-07-07 | Warnings | M020 |
| Natu Botanicals DAILY NATURAL SUNSCREEN SPF 35 Reef safe mineral sunscreen with non-nano zinc oxide | ZINC OXIDE | Surprise Enterprise LLC | 38cf4325-9720-f511-e063-6394a90ad628 | 2026-07-07 | Warnings | M020 |
| Sun Bum Road Tripper - Amazon - Coconut Lip Balm SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Sun Bum, LLC | 560c0f35-2132-52a6-e063-6394a90a2d24 | 2026-07-07 | Warnings | M020 |
| Ciele lip and PROTECT lipstick SPF 60 Bonnie | CIELE LIP AND PROTECT LIPSTICK SPF 60 BONNIE | Delicate Cosmetics Inc | 560d1d19-87a6-179b-e063-6294a90ada5e | 2026-07-07 | Warnings | M020 |
| Ciele lip and PROTECT lipstick SPF 60 Kelly | CIELE LIP AND PROTECT LIPSTICK SPF 60 KELLY | Delicate Cosmetics Inc | 560df34a-e6da-0792-e063-6394a90a7e71 | 2026-07-07 | Warnings | M020 |
| Ciele lip and PROTECT lipstick SPF 60 LouLou | CIELE LIP AND PROTECT LIPSTICK SPF 60 LOULOU | Delicate Cosmetics Inc | 560e37ae-87c0-39d2-e063-6394a90a2af4 | 2026-07-07 | Warnings | M020 |
| Ciele lip and PROTECT lipstick SPF 60 Cassette | CIELE LIP AND PROTECT LIPSTICK SPF 60 CASSETTE | Delicate Cosmetics Inc | 560e4198-b07c-3d48-e063-6394a90a7be3 | 2026-07-07 | Warnings | M020 |
| Ciele lip and PROTECT lipstick SPF 60 Margaux | CIELE LIP AND PROTECT LIPSTICK SPF 60 MARGAUX | Delicate Cosmetics Inc | 560e47d5-c881-438c-e063-6394a90a3091 | 2026-07-07 | Warnings | M020 |
| Ciele lip and PROTECT lipstick SPF 60 Saddle | CIELE LIP AND PROTECT LIPSTICK SPF 60 SADDLE | Delicate Cosmetics Inc | 560e5de5-1350-4046-e063-6394a90abffa | 2026-07-07 | Warnings | M020 |
| Ciele lip and PROTECT lipstick SPF 60 Puzzle | CIELE LIP AND PROTECT LIPSTICK SPF 60 PUZZLE | Delicate Cosmetics Inc | 560e5558-8e46-7736-e063-6294a90acb05 | 2026-07-07 | Warnings | M020 |
| EELHOE Body Coverage Perfector | TITANIUM DIOXIDE | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 5610c3b7-456b-3bc1-e063-6394a90a3fa8 | 2026-07-07 | Warnings | M020 |
| Sunscreen SPF 50 | AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5% | Worthy Promotional Products | 1d4be26a-4695-491c-85d1-86824e1cd029 | 2026-07-06 | Warnings | M020 |
| SPF 30 Sunscreen | HOMOSALATE 10% OCTISALATE 5% AVOBENZONE 3% | Coconut Caliente Costa Rica LLC | 71856cb3-9386-4569-80e4-92826342e386 | 2026-07-06 | Warnings | M020 |
| Stay Ageless Sunscreen | BROAD SPECTRUM SPF 30 | TOXFAIRY, LLC | 55f7e07e-1689-6d38-e063-6294a90a9119 | 2026-07-06 | Warnings | M020 |
| Premier Tinted Mineral Sunscreen | BROAD SPECTRUM SPF30 | Emerald Aesthetics LLC | 55f88dd1-346c-22a5-e063-6294a90a711f | 2026-07-06 | Warnings | M020 |
| RR Sun | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Undefined Inc | 87244432-2967-4145-89cd-11a7567083a3 | 2026-07-06 | Warnings | M020 |
| TOCOBO Cotton Airy Sun Stick | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | PICTON CO., Ltd. | 35af90d3-dfe1-30dc-e063-6294a90a10a5 | 2026-07-05 | Warnings | M020 |
| MDP PEPTIDE 9 BIO SUN PRO | HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE | SKINIDEA CO., LTD | 26db53cd-dd82-8790-e063-6394a90a92b1 | 2026-07-03 | Warnings | M020 |
| SPF 50 plus Sunscreen | TITANIUM DIOXIDE AND ZINC OXIDE | Theravita LLC | d8e276cc-0292-499d-9075-a83a2d3fafcc | 2026-07-02 | Warnings | M020 |
| Sport Sunscreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE | The Kroger Co. | 5880b275-91fc-4589-a076-0e55409425d8 | 2026-07-02 | Warnings, Adverse reactions | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58443-0555-3 | 58443055503 | 59 mL in 1 TUBE (58443-0555-3) | 59 ml | 2017-02-20 | 0000-00-00 | No | No | Current |