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 303 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Florida Squeezed SPF 50 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Florida Squeezed 13696dc6-ae64-4760-e063-6394a90ac192 2024-03-11 Warnings Exact identifier application number: M020 BB Noir 30 BS SPF30 ZINC OXIDE AND TITANIUM DIOXIDE Allure Labs 136a7f66-844c-b16a-e063-6294a90aa975 2024-03-11 Warnings Exact identifier application number: M020 Brush On Block Sheer Genius SPF 50 Mineral Moisture Universal Tint ZINC OXIDE SPF Ventures, LLC 12d27da2-2689-496a-e063-6294a90aaa9f 2024-03-08 Warnings Exact identifier application number: M020 Avene Multi-Defense Fluid ZINC OXIDE Pierre Fabre USA Inc. 1329e56d-1e74-4bcc-e063-6394a90ae0c3 2024-03-08 Warnings Exact identifier application number: M020 Avene Multi-Defense Fluid Tinted ZINC OXIDE Pierre Fabre USA Inc. 132bdf9a-c5d0-e7e5-e063-6394a90a6180 2024-03-08 Warnings Exact identifier application number: M020 Avene Face Sunscreen SPF 50 ZINC OXIDE Pierre Fabre USA Inc. 132ce436-a783-2ba0-e063-6394a90a4b70 2024-03-08 Warnings Exact identifier application number: M020 TROPICAL OTTERS Glitter Sunscreen SPF-50 - Sugar Sparkle HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE 6174 INDUSTRIES, LLC cfd1e0c7-7e4c-41c1-8788-b73f83bf38c9 2024-03-06 Warnings Exact identifier application number: M020 TROPICAL OTTERS Glitter Sunscreen SPF-50 - Fragrance Free HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE 6174 INDUSTRIES, LLC 658b1b20-6540-4f3a-ac9a-170bc8fcba11 2024-03-06 Warnings Exact identifier application number: M020 Daily Facial Moisturizer SPF 15 EQB AVOBENZONE 3% OCTOCRYLENE 10% Walmart a0c452a9-3e99-41b8-b9b2-c1b57b66f183 2024-03-06 Warnings Exact identifier application number: M020 Target Up and Up Sport SPF 50 AVOBENZONE, HOMOSALAT, OCTISALATE, OCTOCRYLENE TARGET CORPORATION b81b2e7e-6d7f-fa1d-e053-2995a90a7d15 2024-03-06 Warnings Exact identifier application number: M020 Target Up and Up Reef Conscious Formula SPF 50 Sport Sunscreen AVOBENZONE, HOMOSALATE, OCTOCRYLENE TARGET CORPORATION b5fd43ee-9fa1-13c1-e053-2995a90a364a 2024-03-06 Warnings Exact identifier application number: M020 Vacation SPF 30 Baby Oil AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Vacation Inc. f6030311-5287-3aa3-e053-2995a90a1b87 2024-03-06 Warnings Exact identifier application number: M020 Brush On Block Sun Shine SPF 30 Protective Lip Oil Nude Tint TITANIUM DIOXIDE/ZINC OXIDE SPF Ventures LLC 12e5493f-6478-0ff4-e063-6394a90af4f5 2024-03-05 Warnings Exact identifier application number: M020 Brush On Block Sun Shine SPF 30 Protective Lip Oil Coral TITANIUM DIOXIDE/ZINC OXIDE SPF Ventures LLC 12e65634-2e6d-b030-e063-6294a90ad1c4 2024-03-05 Warnings Exact identifier application number: M020 Brush On Block Sun Shine SPF 30 Protective Lip Oil Fig TITANIUM DIOXIDE/ZINC OXIDE SPF Ventures LLC 12e7507d-6612-fda4-e063-6294a90a1db7 2024-03-05 Warnings Exact identifier application number: M020 Dermachange SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Private Label Beauty and Wellness 12f00cee-dd9b-19b1-e063-6294a90adccb 2024-03-05 Warnings Exact identifier application number: M020 Brush On Block Quick Stick SPF 40 Mineral Stick ZINC OXIDE SPF Ventures LLC 12d10ec9-847a-7483-e063-6294a90a42a7 2024-03-04 Warnings Exact identifier application number: M020 Lucin Organics Tinted Sunscreen SPF 30 Non Nano Zinc Oxide ZINC OXIDE Lucin Organics, LLC d717dda8-60bb-40a0-86f9-6d724d695d16 2024-03-04 Warnings Exact identifier application number: M020 Brush On Block Bounce Butter SPF 30 Moisturizing Mousse ZINC OXIDE SPF Ventures LLC 12956754-b4e5-0203-e063-6294a90a2b96 2024-03-01 Warnings Exact identifier application number: M020 Derma E Sun Protection Mineral SPF 30 ZINC OXIDE derma e bb8e3df2-23e8-4ad0-a662-ff02d156e7b1 2024-02-26 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