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 176 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join UV SOLUTIONS MATTIFYING BROAD SPECTRUM SPF 50 AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE CLINIQUE LABORATORIES LLC 4198cfc0-a696-e279-e063-6294a90ac239 2025-10-20 Warnings Exact identifier application number: M020 ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Baby Rose ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0e9d9419-a7e1-bc42-e063-6394a90af511 2025-10-20 Warnings Exact identifier application number: M020 ATTITUDE Oceanly Phyto-Sun Tinted Shimmer Cream SPF 30 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0e8af968-77d5-1dcd-e063-6394a90a6699 2025-10-20 Warnings Exact identifier application number: M020 ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Peachy Shell ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0e9e95c3-4ac8-5962-e063-6294a90a0c02 2025-10-20 Warnings Exact identifier application number: M020 ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Terracotta ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0e9dd230-b087-cda7-e063-6394a90ae084 2025-10-20 Warnings Exact identifier application number: M020 ATTITUDE Oceanly Phyto-Sun Tinted Oil SPF 30 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0e9b0642-53ed-ec94-e063-6394a90aec3d 2025-10-20 Warnings Exact identifier application number: M020 ATTITUDE Oceanly Phyto-Sun Tinted Cream SPF 30 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0d977158-8b5d-66ac-e063-6294a90a4d5c 2025-10-20 Warnings Exact identifier application number: M020 ATTITUDE Oceanly Phyto-Sun Kit SPF 30 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0eae4b71-60be-9715-e063-6294a90af463 2025-10-20 Warnings Exact identifier application number: M020 Attitude Oceanly Phyto-Sun Tinted - SPF 15 - Broad Spectrum Sunscreen ZINC OXIDE Attitude DBA 9055-7588 Qubec Inc. 9ed70230-980c-474c-9f72-a6be0f355124 2025-10-20 Warnings Exact identifier application number: M020 HAWAIIAN TROPIC AVOBENZONE OCTISALATE OCTOCRYLENE Edgewell Personal Care Brands LLC 419b8043-7921-ca77-e063-6394a90a99ba 2025-10-20 Warnings Exact identifier application number: M020 Illuminizing Blendrops Broad Spectrum SPF 46 HOMOSALATE, OCTISALATE, ZINC OXIDE Wasatch Product Development, LLC 419c8718-6b9e-3df7-e063-6294a90a1e3b 2025-10-20 Warnings Exact identifier application number: M020 Sonni SunDay Serum ZINC OXIDE Sonni 419d4ada-fe9b-b774-e063-6394a90a3d09 2025-10-20 Warnings Exact identifier application number: M020 Lip Clear Lysine Plus Coldstick OCTINOXATE AND OXYBENZONE Quantum, Inc. 66f84e56-4a5d-4b71-8bd3-79961e7bf4fe 2025-10-20 Warnings Exact identifier application number: M020 Super Lysine Plus Strawberry Lip Treatment OCTINOXATE AND OXYBENZONE Quantum, Inc. 2cafc97f-4cd3-4755-b394-3802c28d4ed5 2025-10-20 Warnings Exact identifier application number: M020 Super Lysine Plus Tangerine Lip Treatment OCTINOXATE AND OXYBENZONE Quantum, Inc. 8a00194e-9e28-4257-82e5-59bc44f7897d 2025-10-20 Warnings Exact identifier application number: M020 Super Lysine Plus Coldstick OCTINOXATE AND OXYBENZONE Quantum, Inc. c9318a8c-ba3b-4068-84df-110c9005ee1d 2025-10-20 Warnings Exact identifier application number: M020 Terez Honor Hydro Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE DEWYCREAM INC 418d054b-436f-6aa3-e063-6294a90a0f56 2025-10-19 Warnings Exact identifier application number: M020 Danahan Moisture Daily Sunscreen Broad Spectrum SPF 50 ENSULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE Cosmocos Co., Ltd 41129799-85ed-2de2-e063-6394a90ab40c 2025-10-17 Warnings Exact identifier application number: M020 Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 70 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC c5a67314-e5b2-4dd6-94e9-39c2f286c346 2025-10-17 Warnings Exact identifier application number: M020 LION POSE GHOST-BUSTER BROAD SPECTRUM SPF 42 SUNSCREEN ZINC OXIDE Lion Pose Inc. 0310407b-fb74-aa8b-e063-6294a90ad841 2025-10-17 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