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 | 2026-10-05 | ||
| excluded package | package | 58443-0555 | 58443-0555-3 | I | Inactivated by FDA | 2026-10-05 |
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 |
|---|---|---|---|---|---|---|
| Intense Therapy Lip Balm Basil Lemon | SUNSCREEN SKIN PROTECTANT LIP BALM | Jack Black, LLC | 277cb44d-608a-4ffc-a2a5-ac57d33d214c | 2026-09-08 | Warnings | M020 |
| Intense Therapy Lip Balm Black Cherry | SUNSCREEN SKIN PROTECTANT LIP BALM | Jack Black, LLC | 8f413bd6-258c-4c3c-89d1-369938c85720 | 2026-09-08 | Warnings | M020 |
| Intense Therapy Lip Balm Cucumber Lime | SUNSCREEN SKIN PROTECTANT LIP BALM | Jack Black, LLC | 5f15bee9-9bf4-4f27-a6b5-4205deb625f6 | 2026-09-08 | Warnings | M020 |
| Intense Therapy Lip Balm Winter Melon | SUNSCREEN SKIN PROTECTANT LIP BALM | Jack Black, LLC | e7792b4e-a6d2-487e-ba28-27b68e6d7e27 | 2026-09-08 | Warnings | M020 |
| Jack Black Intense Therapy Lip Balm Vanilla Bourbon | AVOBENZONE, OCTINOXATE LIP BALM SUNSCREEN | Jack Black, LLC | 517040d1-e6ed-40ca-a46f-2f75403dbc3c | 2026-09-08 | Warnings | M020 |
| Intense Therapy Lip Balm Mango and Mandarin | SUNSCREEN SKIN PROTECTANT LIP BALM | Jack Black, LLC | 8c55d1cd-cdd6-468b-8a17-b940c6210116 | 2026-09-08 | Warnings | M020 |
| Jack Black Intensive Therapy Lip Balm Mango Chili Lime | AVOBENZONE, OCTINOXATE LIP BALM SUNSCREEN | Jack Black, LLC | 51349d57-b14d-4798-8d68-03fbe3713d1e | 2026-09-08 | Warnings | M020 |
| Jack Black Sun Guard Sunscreen SPF45 | SUNSCREEN | Jack Black, LLC | 3cc86bb2-05ce-47eb-8c71-f4f116ca5840 | 2026-09-08 | Warnings | M020 |
| Jack Black Intense Thearpy Lip Balm SPF25, Lemon and Shea Butter | LIP BALM SUNSCREEN | Jack Black, LLC | 518cb17a-fdaa-4a60-93fc-708305366eb8 | 2026-09-08 | Warnings | M020 |
| Jack Black Lavender Lip Balm 0.25oz | LIP BALM SUNSCREEN | Jack Black, L.L.C. | e8c6a6d9-1093-41f1-87d5-faf8583d4319 | 2026-09-08 | Warnings | M020 |
| SPF15 lip balm 01 | OCTOCRYLENE, OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | f8695305-b89d-c21c-e053-6394a90a0e84 | 2026-09-08 | Warnings | M020 |
| Sunscreen stick | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | e9f963ee-a98c-efc1-e053-2a95a90aaf53 | 2026-09-08 | Warnings | M020 |
| SPF30 Sunscreen 01 | AVOBENZONE ,HOMOSALATE,OCTOCRYLENE, OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 5b04751d-32e9-a7e2-e063-6294a90aefbd | 2026-09-08 | Warnings | M020 |
| Juyasuyon Invisible Sunscreen | HOMOSALATE,OCTOCRYLENE,OCTISALATE,BEMOTRIZINOL,AVOBENZONE | Guangdong Aimu Biological Technology Co., Ltd | 5ab335b5-bb9e-4642-e063-6294a90a3986 | 2026-09-05 | Warnings | M020 |
| No7 Future Renew Defense Shield SPF 50 | AVOBENZONE, OCTINOXATE, OCTISALATE | BCMC | 41cc2c52-c6a4-611c-e063-6294a90aae01 | 2026-09-03 | Warnings | M020 |
| WALMART EQUATE SUNSCREEN SPF 50 SPORT BROAD SPECTRUM | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | WALMART, INC. | 58b5d0ce-9157-9dee-e063-6394a90ab543 | 2026-09-02 | Warnings | M020 |
| Chantecaille Ultra Sun Protection Sunscreen SPF 45 | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Chantecaille Beaute Inc | 6186ea56-7d56-43f5-985d-a012f1296afa | 2026-09-02 | Warnings | M020 |
| ULTRA VIOLETTE Fave Screen Broad Spectrum SPF 50 | AVOBENZONE, BEMOTRIZINOL, OCTISALATE | Grace and Fire USA | 5739c5b9-00d8-75a8-e063-6394a90aa8c7 | 2026-09-01 | Warnings | M020 |
| Sun Wave Anti Aging Insta Dry SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Sun Life Brands, LLC | 2d5fa597-08a8-41ca-ba9e-b52e41a5c70c | 2026-09-01 | Warnings | M020 |
| Sunski Hot Block Mineral Sunscreen Stick SPF 50 | ZINC OXIDE | Stewart Charley Ventures LLC dba Sunski | 04ecc5e7-0d9e-4bc7-b964-4cbcc6ed06a8 | 2026-09-01 | Warnings | 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 |