CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES

Product NDC: 58411-421
11-digit product format: 584110421
Labeler code: 58411
Product ID: 58411-421_47ab9e3e-9fc6-3157-e063-6394a90a7a7e
Type: HUMAN OTC DRUG
Nonproprietary name: OCTINOXATE and TITANIUM DIOXIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: SHISEIDO AMERICAS CORPORATION
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-06-01
Substance: OCTINOXATE; TITANIUM DIOXIDE
Active strength: 48; 65 mg/2.2mL; mg/2.2mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 42 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	58411-421-60	`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	58411-421-60	`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	58411-421-60	`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	58411-421-60	`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	58411-421-60	`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	58411-421-60	`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	58411-421-60	`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	58411-421-60	`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	58411-421-60	`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	58411-421-60	`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	58411-421-60	`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	58411-421-60	`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	58411-421-60	`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	58411-421-60	`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	58411-421-60	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	58411-421-60	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	58411-421-60	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	58411-421-60	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	58411-421-60	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	58411-421-60	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	58411-421-60	`9bebd1f3094a…`	`5416666fcb17…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES
Brand name suffix: IVORY
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTINOXATE	48 mg/2.2mL
TITANIUM DIOXIDE	65 mg/2.2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
15FIX9V2JP	Internal UNII lookup
4Y5P7MUD51	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c4028089-677f-4d51-9c8b-3892ff1649e0	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58411-421-60	2026-01-06	C162847	48780-1	9d75b9cf-ce8d-f424-e053-dadaa90a57ce	CLÉ DE PEAU BEAUTÉ RADIANT CORRECTOR FOR EYES
58411-421-60	2020-01-31	C162847	48780-1	9d75b9cf-ce8d-f424-e053-dadaa90a57ce	CLÉ DE PEAU BEAUTÉ RADIANT CORRECTOR FOR EYES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58411-421-60	CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYESIVORY	1 in 1 CARTON	CREAM	1		2
58411-421-60	CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYESIVORY	2.2 mL in 1 TUBE, WITH APPLICATOR	CREAM	2.2		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58411-421	CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES IVORY (OCTINOXATE AND TITANIUM DIOXIDE) CREAM CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES BEIGE (OCTINOXATE AND TITANIUM DIOXIDE) CREAM CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES ALMOND (OCTINOXATE AND TITANIUM DIOXIDE) CREAM CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES OCHER (OCTINOXATE AND TITANIUM DIOXIDE) CREAM CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES MOCHA (OCTINOXATE AND TITANIUM DIOXIDE) CREAM CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES DARK (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [SHISEIDO AMERICAS CORPORATION]	1	Current NDC, Legacy NDC, 2 package rows	20180601_c4028089-677f-4d51-9c8b-3892ff1649e0.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 88 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SHISEIDO BENEFIANCE WRINKLERESIST24 DAY	AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE	SHISEIDO AMERICAS CORPORATION	7d9c0f81-005f-4223-940e-a64143db5275	2026-01-06	Warnings	Exact identifier application number: M020
SHISEIDO FUTURE Solution LX INFINITE TREATMENT PRIMER	TITANIUM DIOXIDE, OCTINOXATE, AND ENSULIZOLE	SHISEIDO AMERICAS CORPORATION	ff088b0c-27c9-4ea8-bf94-6261378c7190	2026-01-06	Warnings	Exact identifier application number: M020
Drs. pharmacy sunscreen SPF 50 (physical filters)	SUNSCREEN SPF 50	OL PHARMA TECH LLC. (Drs. Pharmacy)	31e976a2-0623-0dca-e063-6394a90a08da	2026-01-06	Warnings	Exact identifier application number: M020
SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 115 Fair Shirakaba	OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	26151cf4-0fee-4a42-92fd-4d7b9cef8381	2026-01-06	Warnings	Exact identifier application number: M020
Drs. pharmacy sunscreen SPF 50 (physical filters)	SUNSCREEN SPF 50	OL PHARMA TECH LLC. (Drs. Pharmacy)	315a5ca4-4536-d585-e063-6294a90a1c50	2026-01-06	Warnings	Exact identifier application number: M020
Drs. pharmacy sunscreen SPF 30 (Physical Filters)	SUNSCREEN SPF 30	OL PHARMA TECH LLC. (Drs. Pharmacy)	315a5b1f-9dc2-a243-e063-6394a90a5e08	2026-01-06	Warnings	Exact identifier application number: M020
SHISEIDO ULTIMATE SUN PROTECTOR	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	SHISEIDO AMERICAS CORPORATION	51f759b7-8c49-41d4-aaa3-f901d599cac5	2026-01-06	Warnings	Exact identifier application number: M020
cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED n (Refill)	AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE	SHISEIDO AMERICAS CORPORATION	463dc557-9743-4a38-969e-2c78fc10ee2a	2026-01-06	Warnings	Exact identifier application number: M020
CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n	AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE	SHISEIDO AMERICAS CORPORATION	23bb4225-bfb5-47e2-80fe-733761ba4069	2026-01-06	Warnings	Exact identifier application number: M020
SHISEIDO WHITE LUCENT DAY	AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE	SHISEIDO AMERICAS CORPORATION	e881e637-e0f0-4c90-8343-2be6e74020b8	2026-01-06	Warnings	Exact identifier application number: M020
Hawaiian Tropic Lip Balm Sunscreen SPF 30	AVOBENZONE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	c7b71be3-f906-bd09-e053-2995a90adc61	2026-01-06	Warnings	Exact identifier application number: M020
SHISEIDO BENEFIANCE WRINKLERESIST24 DAY	AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE	SHISEIDO AMERICAS CORPORATION	d308d578-c881-4c10-8c79-9e3cd58b694c	2026-01-06	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	051b7413-8f1b-7135-e063-6294a90a9364	2026-01-06	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen Lip Balm SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE,	Beiersdorf Inc	47bc6776-1130-0162-e063-6294a90a2adc	2026-01-06	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	088fa3cd-b9b8-d10b-e063-6394a90a7fd6	2026-01-06	Warnings	Exact identifier application number: M020
SPF 50 Florida Sun Defense Broad Spectrum SPF 50 Sunscreen Body Oil	HOMOSALATE, OCTISALATE, OCTOCRYLENE	Naples Soap Company, Inc.	47c147a9-c4f4-ab82-e063-6394a90aaa5c	2026-01-06	Warnings	Exact identifier application number: M020
PoutScreen Lip Treatment Love Letter	AVOBENZONE, OCTINOXATE, OCTOCRYLENE	NAKED SUNDAYS PTY LTD	47d22c6d-49fd-f97c-e063-6294a90a6ba1	2026-01-06	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands, LLC	56ab90db-51bd-ffb3-e063-6294a90a852b	2026-01-06	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands, LLC	56ac28e7-41f1-bd4e-e063-6294a90a0e7b	2026-01-06	Warnings	Exact identifier application number: M020
Moisturizing Antioxidant SPF 50	OCTINOXATE, OCTISALATE, HOMOSALATE, OXYBENZONE, ZINC OXIDE	Topiderm, Inc.	727c14d3-ad26-4e8b-91f6-b7a5f07e4e2f	2026-01-05	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
58411-421-60	58411042160	1 TUBE, WITH APPLICATOR in 1 CARTON (58411-421-60) / 2.2 mL in 1 TUBE, WITH APPLICATOR	2018-06-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CLÉ DE PEAU BEAUTÉ RADIANT CORRECTOR FOR EYES	SHISEIDO AMERICAS CORPORATION \| SHISEIDO AMERICA INC.	2026-01-05	HUMAN OTC DRUG LABEL	2