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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	58443-0555		I	Inactivated by FDA		2026-10-23
excluded package	package	58443-0555	58443-0555-3	I	Inactivated by FDA		2026-10-23

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#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58443-0555-3	2024-01-30	C162847	48780-1	1030e365-6dbb-111a-e063-dadaa90a10e2	Soleil Toujors Set + Protect Micro Mist Broad Spectrum SPF 30 Sunscreen

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 167 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Well People Bio Tint SPF 30 Sunscreen 7N	ZINC OXIDE	e.l.f. Cosmetics, Inc	c8aa6047-ce45-59f7-e053-2a95a90a678e	2025-11-07	Warnings	Exact identifier application number: M020
Well People Bio Tint SPF 30 Sunscreen 8N	ZINC OXIDE	e.l.f. Cosmetics, Inc	c8aa662c-0f06-712b-e053-2995a90aae0b	2025-11-07	Warnings	Exact identifier application number: M020
Well People Lip Butter SPF 15 Sunscreen AFTERGLOW	ZINC OXIDE	e.l.f. Cosmetics, Inc	c8aa9325-4fad-ddf9-e053-2a95a90a6639	2025-11-07	Warnings	Exact identifier application number: M020
Well People Bio Tint SPF 30 Sunscreen 9w	ZINC OXIDE	e.l.f. Cosmetics, Inc	c8a92c58-d981-0948-e053-2a95a90a16f8	2025-11-07	Warnings	Exact identifier application number: M020
Well People Lip Butter SPF 15 Sunscreen WINE	ZINC OXIDE	e.l.f. Cosmetics, Inc	c8aa873e-8271-8cf0-e053-2995a90a3cec	2025-11-07	Warnings	Exact identifier application number: M020
Well People Lip Butter SPF 15 Sunscreen NATURAL	ZINC OXIDE	e.l.f. Cosmetics, Inc	c8aa7ae9-7d03-db7d-e053-2995a90ae72b	2025-11-07	Warnings	Exact identifier application number: M020
Neutrogena Clear Face Serum Fragrance Free SPF 60 Plus	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kenvue Brands LLC	eb705402-f8cb-5079-e053-2a95a90a405c	2025-11-06	Warnings	Exact identifier application number: M020
Neutrogena Cool Dry Sport Sunscreen Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	5c1a0437-c269-4cd3-b91a-e2de799b853e	2025-11-06	Warnings	Exact identifier application number: M020
Neutrogena Clear Face Breakout Free oil Free Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	10ca67ca-c372-44a9-8933-84cce9fb9934	2025-11-06	Warnings	Exact identifier application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	0464448b-342b-4e54-a20e-6ec6bd622889	2025-11-06	Warnings	Exact identifier application number: M020
Neutrogena Hydro Boost Water Gel Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	7f60d6bd-1735-4390-bc8a-e3876ab7ad50	2025-11-06	Warnings	Exact identifier application number: M020
Neutrogena Hydro Boost Hyaluronic Acid Moisturizer with Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	ea876490-979b-401c-a6bf-35649e7deda0	2025-11-06	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Moisturizing Face Serum Sunscreen Broad Spectrum SPF 60 Plus	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	cdbe250b-2b64-78fd-e053-2995a90a6c33	2025-11-06	Warnings	Exact identifier application number: M020
Aveeno Favorites	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kenvue Brands LLC	f3c925cc-7993-70bb-e053-2a95a90abdde	2025-11-06	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF45	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	2510d9fe-2aa7-44ee-9525-ad5163dfee94	2025-11-06	Warnings	Exact identifier application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 60 Plus	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	39710a1a-fe8c-41f2-b60c-db3e99d60a86	2025-11-06	Warnings	Exact identifier application number: M020
Neutrogena Boost Your Skins Vitals Team Regenerate	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	0acd9110-4ba5-227a-e063-6294a90ad942	2025-11-06	Warnings	Exact identifier application number: M020
Neutrogena Clear Face Breakout Free Oil Free Broad Spectrum SPF 55	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	Kenvue Brands LLC	3e25a4ce-dbdd-4830-a3d8-a2dfb3bcb078	2025-11-06	Warnings	Exact identifier application number: M020
Neutrogena Oil Free Moisture Broad Spectrum SPF15	AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	Kenvue Brands LLC	18303bc2-2e00-4a9e-900f-86397ca9d163	2025-11-06	Warnings	Exact identifier application number: M020
Neutrogena Invisible Daily Defense Fragrance Free SPF 60 Plus	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kenvue Brands LLC	eb7022e7-0929-fdb4-e053-2995a90a9e6c	2025-11-06	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Soleil Toujors Set + Protect Micro Mist Broad Spectrum SPF 30 Sunscreen	Prime Enterprises Inc.	2022-08-16	HUMAN OTC DRUG LABEL	1