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 38 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join RE SCREEN BROAD SPECTRUM SPF 30 SUNSCREEN ZINC OXIDE Zouck LLC 507560fe-c7ad-329a-e063-6394a90a039a 2026-04-27 Warnings Exact identifier application number: M020 SoloVegan HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE YES SALES INC. 435748e6-c39a-efee-e063-6294a90ad0e5 2026-04-27 Warnings Exact identifier application number: M020 SCREEN SCREEN BROAD SPECTRUM SPF 30 SUNSCREEN ZINC OXIDE Zouck LLC 50764f40-7881-81a3-e063-6294a90ad1cf 2026-04-27 Warnings Exact identifier application number: M020 Obagi Skintrinsiq Antioxidant Protocol AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE Obagi Cosmeceuticals LLC 495bc176-b292-448f-a5a6-00de2e475e54 2026-04-27 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f45bd7bd-a802-33e4-e053-2a95a90a61a7 2026-04-23 Warnings Exact identifier application number: M020 TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMER TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMER PML NYC, LLC 1c2e9b0d-ba0e-1767-e063-6394a90a756c 2026-04-23 Warnings Exact identifier application number: M020 Skincare LdeL Retinol Day Broad Spectrum SPF 20 AVOBENZONE, HOMOSALATE, OXYBENZONE, AND OCTINOXATE Beauty Solutions, Ltd. 76e2ed34-c643-402b-9c9d-04eac789d3c2 2026-04-22 Warnings Exact identifier application number: M020 Johnsons Baby Mineral Sunscreen SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Kenvue Brands LLC 4fe04c4b-2751-0561-e063-6394a90af768 2026-04-22 Warnings Exact identifier application number: M020 Johnsons Baby Mineral Sunscreen Stick SPF 50 ZINC OXIDE Kenvue Brands LLC 4fe1d3c6-7748-d966-e063-6394a90a97ff 2026-04-22 Warnings Exact identifier application number: M020 OVERLAPS ECTOIN MOIST SUN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Overlaps Corp. 4c3ed60b-e515-8ff0-e063-6294a90a86df 2026-04-22 Warnings Exact identifier application number: M020 Lazy Face SPF 30 Facescreen TITANIUM DIOXIDE, ZINC OXIDE Sunny Day Creations 500ee303-7302-68d5-e063-6394a90ac6d4 2026-04-22 Warnings Exact identifier application number: M020 Lazy Face SPF 30 Facestick ZINC OXIDE Sunny Day Creations 50101b55-793e-dbe4-e063-6394a90a6199 2026-04-22 Warnings Exact identifier application number: M020 Broad Spectrum Sunscreen SPF 30 OCTOCRYLENE 10% HOMOSALATE 10% OCTISALATE 5 % AVOBENZONE 3% S&C Hampton Sun LLC e6103de6-1d80-46fd-b9d4-893f60941def 2026-04-22 Warnings Exact identifier application number: M020 PhotoAge Guard AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE MACROMOTION, INC. 50164bd8-469d-9ec1-e063-6294a90a543d 2026-04-22 Warnings Exact identifier application number: M020 THANK YOU FARMER Sun Project Silky Calming Sun Stick AVOBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENE THANK YOU FARMER CO., LTD 49947114-5137-dc45-e063-6394a90ad9d0 2026-04-22 Warnings Exact identifier application number: M020 Sky and Sol Intense Healing Lip Jelly NON-NANO ZINC OXIDE Delta Ecommerce LLC 2ddaa215-7433-c8fa-e063-6394a90a4316 2026-04-22 Warnings Exact identifier application number: M020 Broad Spectrum SPF45 ZINC OXIDE, OCTINOXATE Drmtlgy, LLC 0445ee5f-45a8-4fd5-ae4d-62f66e6f0be8 2026-04-21 Warnings Exact identifier application number: M020 BLDG Active Skin Repair Face and Body Performance Sunscreen ZINC OXIDE Innovacyn, Inc. 70cb98cf-739b-4d46-b45a-535ff0a4531c 2026-04-21 Warnings Exact identifier application number: M020 Freaks of Nature Mineral Sunscreen ZINC OXIDE MINERAL SUNSCREEN Empack Spraytech Inc. 4ffdb1c6-b2c6-628f-e063-6394a90a2769 2026-04-21 Warnings Exact identifier application number: M020 THANK YOU FARMER Sun Project Water Sun Cream AVOBENZONE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENE THANK YOU FARMER CO., LTD 5004126b-0a9c-21fb-e063-6294a90a5237 2026-04-21 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