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 301 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Carmex Daily Care Moisturizing Lip Balm SPF 15 Assorted HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE Carma Laboratories, Inc. 22821e9d-eb3a-4e21-87ae-737b25125534 2024-04-03 Warnings Exact identifier application number: M020 Meadow and Bark SPF 45 Mineral Shimmer Sunscreen ZINC OXIDE Meadow and Bark 14bbd191-ef3b-628e-e063-6294a90a1e66 2024-04-03 Warnings Exact identifier application number: M020 Meadow and Bark SPF 45 Mineral Sport Sunscreen ZINC OXIDE Meadow and Bark 1494c0e1-97f5-411c-e063-6294a90ab2ca 2024-04-03 Warnings Exact identifier application number: M020 LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 LATTE 180-F OCTINOXATE, ZINC OXIDE BEL STAR S A ea3a0e07-a277-48c8-e053-2a95a90a172f 2024-04-02 Warnings Exact identifier application number: M020 Rio Radiance SPF 50 BodySpray OCTOCRYLENE, OCTISALATE, AVOBENZONE Sol de Janeiro USA, Inc 1520a151-70c4-8699-e063-6294a90adc6b 2024-04-02 Warnings Exact identifier application number: M020 Meijer SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Meijer 075efd92-1632-d8c8-e063-6294a90a8c1a 2024-04-02 Warnings Exact identifier application number: M020 Good Molecules Sheer Mineral Sunscreen SPF 30 ZINC OXIDE Good Molecules, LLC e9596344-a7ab-f582-e053-2a95a90a5525 2024-04-02 Warnings Exact identifier application number: M020 Carmex Daily Care Moisturizing Lip Balm SPF15 Broad Sprectrum Minis HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE Carma Laboratories, Inc. f5c4186e-f167-40fc-b308-0b4406d3ec55 2024-04-02 Warnings Exact identifier application number: M020 Carmex Daily Care Moisturizing Lip Balm SPF15 Broad Sprectrum Minis Holiday AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Carma Laboratories, Inc. 95d9a485-7418-437a-8e7d-ebcc09088356 2024-04-02 Warnings Exact identifier application number: M020 Rejuvenating Priming Moisturizer BS Sunscreen SPF30 ZINC OXIDE Allure Labs 14cff1a3-89b9-f4da-e063-6394a90a1a41 2024-03-29 Warnings Exact identifier application number: M020 Lemongrass Spa Products SPF 45 Tinted Mineral Sunscreen ZINC OXIDE Lemongrass Spa Products, LLC 14bcbaf9-76a5-f8ba-e063-6294a90a91f6 2024-03-28 Warnings Exact identifier application number: M020 Rubber Ducky SPF 50 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Carefree Skincare Ventures, LLC 14bd5cf9-423e-53a8-e063-6394a90a29f1 2024-03-28 Warnings Exact identifier application number: M020 RV Illuminance Serum Tint Broad Spectrum 15 FACE FOUNDATION WITH SPF REVLON CONSUMER PR Consumer Products Corp 132aab60-da19-7079-e063-6394a90a1d76 2024-03-27 Warnings Exact identifier application number: M020 NAELI TINT Tinted Mineral Moisturizer SPF 50 ZINC OXIDE ALLI LLC 25a88843-078b-4589-b8b7-ea439ba6a15b 2024-03-27 Warnings Exact identifier application number: M020 Rio Radiance SPF 50 BodyLotion ZINC OXIDE SOL DE JANEIRO USA, INC. 14a85a88-c9a2-94ea-e063-6394a90a4e14 2024-03-27 Warnings Exact identifier application number: M020 Rio Radiance SPF 50 Body Oil OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE SOL DE JANEIRO USA, INC. 14acf152-e72a-debb-e063-6294a90a243d 2024-03-27 Warnings Exact identifier application number: M020 RV Illuminance Serum Tint Broad Spectrum 15 Amber FACE FOUNDATION WITH SPF REVLON CONSUMER PR Consumer Products Corp 2a0ac71c-e53a-5ff9-e063-6394a90a4807 2024-03-27 Warnings Exact identifier application number: M020 EltaMD UV Pure SPF47 ZINC OXIDE AND TITANIUM DIOXIDE SUNSCREEN CP Skin Health Group, Inc. 9afe900b-4186-4189-a871-ad6f26fc26e4 2024-03-27 Warnings Exact identifier application number: M020 Eminence Daily Defense Tinted SPF ZINC OXIDE Eminence Organic Skin Care 14854bad-317e-154d-e063-6294a90a884f 2024-03-25 Warnings Exact identifier application number: M020 SPF 50 Mineral Based Facial Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Hutton, Kathleen MD 5cf0d2e3-d496-424c-ac75-70ff5b87e9ca 2024-03-25 Warnings 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