Home NDC 58443-0555 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 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.
Historic NDC status page 1 of 1 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table 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# DailyMed Package Descriptions# Package NDC, Product, Description table 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 table 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.
Matched openFDA labels page 135 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mineral Lip Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE DR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST 3728ec6a-7de5-bbc5-e063-6294a90a31b7 2025-12-11 Exact identifier application number: M020 SUNerchi Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE SYNERCHI MED SPA, INC. 37db5721-2b32-d4d8-e063-6294a90a47d7 2025-12-11 Exact identifier application number: M020 SUNerchi Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE SYNERCHI MED SPA, INC. 37db14e1-f995-b649-e063-6294a90afd69 2025-12-11 Exact identifier application number: M020 208 ZINC OXIDE PETER L. KOPELSON, M.D. 351ce033-6bd0-574e-e063-6394a90af448 2025-12-11 Exact identifier application number: M020 208 ZINC OXIDE PETER L. KOPELSON, M.D., 351c9727-d7ac-9c3f-e063-6294a90a7721 2025-12-11 Exact identifier application number: M020 Replenishing Daily Protection Tinted ZINC OXIDE MY FAVORITE PLACE SPA LLC 351c0c1e-5712-1e23-e063-6394a90abe6f 2025-12-11 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Saving Face Skinspa Inc. 351d27e3-00d4-8d31-e063-6394a90aaf72 2025-12-11 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Saving Face Skinspa Inc. 351db99e-262f-b67e-e063-6394a90a3418 2025-12-11 Exact identifier application number: M020 Replenishing Daily Protection NT ZINC OXIDE MY FAVORITE PLACE SPA LLC 351c5f6f-86e6-7219-e063-6294a90a3745 2025-12-11 Exact identifier application number: M020 Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE DAISY'S SKIN TRANSFORMATION LLC 37d9fbf5-d602-d3dc-e063-6394a90abe53 2025-12-11 Exact identifier application number: M020 Tinted Mineral 40 TITANIUM DIOXIDE, ZINC OXIDE 2301 PLASTIC SURGERY, PLLC 374d53a7-be0b-4d7a-e063-6394a90a37c4 2025-12-11 Exact identifier application number: M020 Daily Protection 40 ZINC OXIDE 2301 PLASTIC SURGERY, PLLC 374d9c77-ed9f-a518-e063-6394a90a34fa 2025-12-11 Exact identifier application number: M020 Tinted Mineral 40 TITANIUM DIOXIDE, ZINC OXIDE 2301 PLASTIC SURGERY, PLLC 374df66d-eb9b-c4a7-e063-6394a90a3cc6 2025-12-11 Exact identifier application number: M020 Daily Protection 40 ZINC OXIDE 2301 PLASTIC SURGERY, PLLC 374e2294-7281-c7b9-e063-6394a90acc89 2025-12-11 Exact identifier application number: M020 Facial Mineral Sunscreen Mineral Protection TITANIUM DIOXIDE, ZINC OXIDE CAPE COD SKIN CARE CO. INC. 387f6dd5-3901-0849-e063-6294a90af8bc 2025-12-11 Exact identifier application number: M020 Non - Tinted Mineral Sunscreen ZINC OXIDE NEXTEX CORPORATION 35bacfcf-0254-aa0a-e063-6394a90a1475 2025-12-11 Exact identifier application number: M020 Facial Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE LEDUC, XUANTO MD 387e2e59-c5db-c70e-e063-6394a90a2d26 2025-12-11 Exact identifier application number: M020 Facial Mineral Sunscreen Mineral Protection TITANIUM DIOXIDE, ZINC OXIDE CAPE COD SKIN CARE CO. INC. 390779a8-4556-27a5-e063-6294a90a1200 2025-12-11 Exact identifier application number: M020 non-tinted sheer matte mineral TITANIUM DIOXIDE, ZINC OXIDE NEXTEX CORPORATION 35ba6cc9-0d49-6d0c-e063-6394a90ac7c3 2025-12-11 Exact identifier application number: M020 sheer tinted matte mineral TITANIUM DIOXIDE, ZINC OXIDE NEXTEX CORPORATION 35ba9ca7-fe5c-9824-e063-6394a90a5c46 2025-12-11 Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table 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