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 178 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sunforgettable Total Protection Sport Stick ZINC OXIDE Colorescience d3c0d2b0-f411-565d-e053-2a95a90a081b 2025-10-15 Warnings Exact identifier application number: M020 Defend and Balance TInted Mineral Sunscreen SPF 50 SUNSCREEN Epicuren Discovery 41367f05-59d8-6736-e063-6394a90a5f17 2025-10-15 Warnings Exact identifier application number: M020 Banana Boat AVOBENZONE HOMOSALATE OCTOCRYLENE Edgewell Personal Care Brands LLC 41376da3-5274-b133-e063-6394a90afa13 2025-10-15 Warnings Exact identifier application number: M020 Curology Daily Moisturizing Sunscreen SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Curology ee59d52e-5dc6-4fb4-96d8-0bda40e23009 2025-10-15 Warnings Exact identifier application number: M020 SUNFORGETTABLE TOTAL PROTECTION COLOR BALM COLLECTION ENDLESSS ENDLESS SUNSET ZINC OXIDE Colorescience f4aa14ed-6c6f-8301-e053-2a95a90a5e23 2025-10-15 Warnings Exact identifier application number: M020 Curology The Lip Balm Broad Spectrum SPF 30 Sunscreen ZINC OXIDE Curology Inc. e441b13f-cb58-457f-e053-2a95a90adab9 2025-10-15 Warnings Exact identifier application number: M020 Curology Everyday Sunscreen Broad Spectrum SPF 30 No-clog UV defense ZINC OXIDE Curology 39a2a297-3af2-40d3-8b5d-f4eef2487fb2 2025-10-15 Warnings Exact identifier application number: M020 Colorescience Total Protection No Show Mineral Sunscreen ZINC OXIDE Colorescience 00d8bf32-aecd-22da-e063-6294a90a7567 2025-10-15 Warnings Exact identifier application number: M020 Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Sand ZINC OXIDE Cosmetic Enterprises Ltd 253c105b-215b-1e6e-e063-6294a90a11d7 2025-10-14 Warnings Exact identifier application number: M020 Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Tan ZINC OXIDE Cosmetic Enterprises Ltd 265bbb1a-ba96-6598-e063-6394a90a9415 2025-10-14 Warnings Exact identifier application number: M020 Resist Wrinkle Defense SPF 30 Paulas Choice ZINC OXIDE Cosmetic Enterprises Ltd d658fdc7-9dac-47bf-8e83-1433a29a6cf6 2025-10-14 Warnings Exact identifier application number: M020 SPF 50 Face Sunscreen Bioelements AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE Cosmetic Enterprises Ltd 498b16c8-ba54-4a0a-8dbc-4b5cc368e214 2025-10-14 Warnings Exact identifier application number: M020 Skin Balancing Ultra Sheer Daily Defence SPF 30 Paulas Choice AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OXYBENZONE Cosmetic Enterprises Ltd 3bf31626-5580-457b-8a59-cc37f4ab0767 2025-10-14 Warnings Exact identifier application number: M020 Sunscreen Broad Spectrum SPF 30 Light Tropical Scent ZINC OXIDE Cosmetic Enterprises Ltd d8c7b82d-6151-2199-e053-2a95a90a6c20 2025-10-14 Warnings Exact identifier application number: M020 TOCOBO Cotton Airy Sun Stick AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE PICTON CO., Ltd. 412975d8-0b8b-23bf-e063-6294a90a5568 2025-10-14 Warnings Exact identifier application number: M020 TOCOBO Bio Watery Sun Screen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE PICTON CO., Ltd. 4129e00b-951d-adbf-e063-6294a90a675e 2025-10-14 Warnings Exact identifier application number: M020 Sunny Sailor First Mate Face Stick SPF 30 ZINC OXIDE SUNNY SAILOR LLC c7908385-ff93-4c6c-9462-081c73023571 2025-10-13 Warnings Exact identifier application number: M020 Cloud Brush On Sunscreen SPF 50 ZINC OXIDE FUTURE 8 LLC 8b1eaf6c-9cd8-4c5e-beac-b8539c332ae3 2025-10-13 Warnings Exact identifier application number: M020 Sunplus Mist Sunscreen SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE SUNPLUS SKIN CARE LLC 951a7bdc-d5c5-4241-a482-c30a4b44f776 2025-10-13 Warnings Exact identifier application number: M020 Sunplus Mist Sunscreen SPF 50 AVOBENZONE, OCTISALATE, OCTOCRYLENE SUNPLUS SKIN CARE LLC da338ba7-7a92-4157-97f4-5ae9cc64853c 2025-10-13 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