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		2026-11-13
excluded package	package	58443-0555	58443-0555-3	I	Inactivated by FDA		2026-11-13

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 288 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bali Body Watermelon Tanning Oil SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Bali Body Pty Ltd	1fd37cec-807e-ddd3-e063-6294a90ae88e	2024-08-16	Warnings	Exact identifier application number: M020
SunPlus SPF 30 Everyday Inspired Broad Spectrum Sunscreen	AVOBENZONE, OCTISALATE, OCTOCRYLENE	SUNPLUS SKIN CARE LLC	fcae486a-5ea8-4f33-98bf-ec68a13d6b8a	2024-08-15	Warnings	Exact identifier application number: M020
SunPlus SPF 50 Everyday Inspired Broad Spectrum Sunscreen	AVOBENZONE, OCTISALATE, OCTOCRYLENE	SUNPLUS SKIN CARE LLC	a2a028a1-3f35-45f6-99a9-8a1c8b4c1f9b	2024-08-15	Warnings	Exact identifier application number: M020
SKINRAYS Protective Bounce Butter Broad Spectrum SPF 30 Mineral Sunscreen by Glam up	ZINC OXIDE	Spigen Beauty Inc.	94c0d586-8de5-45d1-8a82-07555996e61d	2024-08-14	Warnings	Exact identifier application number: M020
FUTURIST HYDRA RESCUE MOISTURIZING MAKEUP BROAD SPECTRUM SPF 45	ENSULIZOLE, OCTINOXATE, OCTISALATE, AND ZINC OXIDE	ESTEE LAUDER INC	82db54ba-3ebd-4b70-b41c-b0d2faad7daa	2024-08-13	Warnings	Exact identifier application number: M020
DERMA BRITE SPF 35	OCTINOXATE, OCTISALATE, OXYBENZONE	PHARMAGEL INTERNATIONAL INC	fe10912e-00e3-406c-a80c-d9c991dc9f8b	2024-08-13	Warnings	Exact identifier application number: M020
SUN THERAPE FACE AND BODY SPF-35	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	PHARMAGEL INTERNATIONAL INC	6a96623f-c37c-4e67-925e-f133461d726d	2024-08-13	Warnings	Exact identifier application number: M020
SUN THERAPE SPORT SPF-35	HOMOSALATE, OCTINOXATE, OXYBENZONE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	PHARMAGEL INTERNATIONAL INC	0cc0de1e-c1c0-4a8a-ba5a-21e2470d61d9	2024-08-13	Warnings	Exact identifier application number: M020
Biocorneum	AVOBENZONE, HOMOSALATE, MERADIMATE, OCTISALATE, AND OCTOCRYLENE	Biodermis LLC	ef95f2b7-e438-4990-880d-81621edb2002	2024-08-13	Warnings	Exact identifier application number: M020
TiZO ULTRA ZINC Non-Tinted SPF 40 MINERAL SUNSCREEN FOR BODY and FACE With Antioxidants C and E	ZINC OXIDE	Fallien Cosmeceuticals, Ltd	1f417082-5fd1-c95e-e063-6394a90a16ab	2024-08-09	Warnings	Exact identifier application number: M020
Proceuticals Private Label by TiZO non-tinted foaming mineral sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, Ltd	1f4491ab-95b0-cc14-e063-6394a90a73ca	2024-08-09	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 7.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b737146d-fb50-4ed6-ab5e-6aff3393992a	2024-08-07	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	54b07420-6a30-4481-99f5-a7d6a4df898c	2024-08-07	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 7W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	65659277-cd30-453c-929e-3651c9f19da8	2024-08-07	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	28ae9c39-eb79-4a19-8149-af8d8e7901ae	2024-08-07	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6.5W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	05f7119a-0c92-4393-a62d-8e84ec451d20	2024-08-07	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b90ee1ba-17b5-4367-9df3-e9e27217960c	2024-08-07	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	ad5c5121-d75d-449d-a4db-a7b074787f68	2024-08-06	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 00	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	0018573d-922b-4642-9513-63481e9131d5	2024-08-06	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	83b20b0d-c2db-4720-8434-57b73847ebca	2024-08-06	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