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 154 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLINIQUE FOR MEN DAILY HYDRATOR BROAD SPECTRUM SPF 35	AVOBENZONE,HOMOSALATE,OCTISALATE, AND OCTOCRYLENE	CLINIQUE LABORATORIES LLC	44fe7468-001c-f2ee-e063-6394a90ae3b4	2025-12-02	Warnings	Exact identifier application number: M020
ATTITUDE Super Leaves Lip Balm SPF15 Unscented	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	44ff1fc0-9ac5-2c9a-e063-6294a90a4632	2025-12-02	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Lip Balm SPF 15 Coconut	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	44ff5675-fd8d-b665-e063-6294a90a1e0b	2025-12-02	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Lip Balm SPF 15 Pineapple	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	44ffb35b-80f4-7ddb-e063-6394a90a2cbb	2025-12-02	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	44ffd469-0205-846f-e063-6294a90af6b5	2025-12-02	Warnings	Exact identifier application number: M020
COSRX	VITAMIN E VITALIZING SUNSCREEN	COSRX inc.	daf0291e-770c-eaf2-e053-2a95a90a0b67	2025-12-01	Warnings	Exact identifier application number: M020
Centellian24 Madeca Derma Shield Vital Dewy Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTROCRYLENE	70541	44e0098c-170f-ca51-e063-6294a90aed20	2025-12-01	Warnings	Exact identifier application number: M020
Centellian24 Madeca Derma Shield Vital Sun Essence	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	70541	44e194cd-ea61-71b3-e063-6394a90ac486	2025-12-01	Warnings	Exact identifier application number: M020
Venture Performance Sun Protection Mineral Sunscreen SPF 50	ZINC OXIDE	Venture Performance Inc	630fc5c2-a315-4e26-9bd9-5f8533d75908	2025-12-01	Warnings	Exact identifier application number: M020
EMINENCE Red Currant Protective Moisturizer	OCTINOXATE, ZINC OXIDE	Eminence Organic Skin Care	7eca62af-6f70-44ec-879e-74712163c4e0	2025-12-01	Warnings	Exact identifier application number: M020
CHARLOTTE TILBURY Broad Spectrum SPF 50 Sunscreen Invisible UV Flawless Poreless Primer	AVOBENZONE, OCTINOXATE, OCTISALATE AND OCTOCRYLENE	Charlotte Tilbury Beauty Ltd.	2b215ecb-7c3a-63db-e063-6394a90aa88f	2025-12-01	Warnings	Exact identifier application number: M020
P.CALM Water Barrier Sunscreen SPF 50 Broad Spectrum	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	LIFE WITHCORPORATION Inc.	44ea9fb4-8e01-6969-e063-6294a90a6a94	2025-12-01	Warnings	Exact identifier application number: M020
ROC MULTI CORREXION - EVEN TONE AND LIFT - 5-In-1 Chest, Neck, and Face Cream Sunscreen - Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATA, OCTISALATE, OCTOCRYLENE	Roc Skincare	2b3656d6-4b3a-9ef2-e063-6294a90acaa6	2025-12-01	Warnings	Exact identifier application number: M020
UNCOMPLIKATED MAKEUP SETTING SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Rare Beauty Brands Inc.	44ec0db5-4437-e4a3-e063-6294a90a9a00	2025-12-01	Warnings	Exact identifier application number: M020
RoC Retinol Correxion Wrinkle Correct Daily Moisturizer SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	RoC Skincare	2888a198-116b-8441-e063-6394a90a0f95	2025-12-01	Warnings	Exact identifier application number: M020
ReefSafe Very High Sun Protection sunscreen	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	44ec619f-ed3b-2fd3-e063-6294a90a858b	2025-12-01	Warnings	Exact identifier application number: M020
Reef safe - Face and Body sunscreen SPF50	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	38603298-e8da-e4c7-e063-6394a90aca3b	2025-12-01	Warnings	Exact identifier application number: M020
ReefSafe Baby and Toddlers Sunscreen SPF50	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	44dd513e-ebaa-0d6a-e063-6394a90a78b7	2025-11-30	Warnings	Exact identifier application number: M020
Safe4Kidz Natural Mineral Sunscreen SPF50	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	44ddc0ae-a977-3adf-e063-6294a90a0898	2025-11-30	Warnings	Exact identifier application number: M020
Safe4Kidz Baby Zinc Sunscreen SPF50	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	44ddc4d8-3f3b-5d11-e063-6294a90ae88a	2025-11-30	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