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 338 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Strawberry Limoncello SPF 15 Broad Spectrum Lip Balm	STRAWBERRY LIMONCELLO SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	c222bd6e-59b0-394a-e053-2995a90ae429	2023-10-18	Warnings	Exact identifier application number: M020
Raspberry Lime Margarita SPF 15 Broad Spectrum Lip Balm	RASPBERRY LIME MARGARITA SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	c2150247-ff7d-9863-e053-2995a90a3f01	2023-10-18	Warnings	Exact identifier application number: M020
Key Lime Pie Shake SPF 15 Broad Spectrum Lip Balm	KEY LIME PIE SHAKE SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	c214e5c2-53ea-31bd-e053-2995a90a886a	2023-10-18	Warnings	Exact identifier application number: M020
Summer Sangria SPF 15 Broad Spectrum Lip Balm	SUMMER SANGRIA SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	c222cc2d-232c-0f3d-e053-2995a90af79b	2023-10-18	Warnings	Exact identifier application number: M020
Broad Spectrum SPF 30 Mineral Sun Stick	BROAD SPECTRUM SPF 30 MINERAL SUN STICK	Raining Rose	c2261a55-12e4-9a75-e053-2a95a90a8211	2023-10-18	Warnings	Exact identifier application number: M020
Broad Spectrum SPF 30 Sunscreen	BROAD SPECTRUM SPF 30 SUNSCREEN	Raining Rose	c238ce45-91d9-e9fa-e053-2a95a90a7d65	2023-10-18	Warnings	Exact identifier application number: M020
Broad Spectrum SPF 30 Sunscreen	BROAD SPECTRUM SPF 30 SUNSCREEN	Raining Rose	c23d49bd-8447-4920-e053-2a95a90a0a06	2023-10-18	Warnings	Exact identifier application number: M020
Tropical Mint Broad Spectrum SPF 15 Lip Moisturizer	TROPICAL MINT SPF 15 BROAD SPECTRUM LIP MOISTURIZER	Raining Rose, Inc	aef6b419-efac-4e37-e053-2995a90a0d2f	2023-10-18	Warnings	Exact identifier application number: M020
Broad Spectrum SPF 15 Sunscreen Cherry Lip Balm	BROAD SPECTRUM SPF 15 SUNSCREEN CHERRY LIP BALM	Raining Rose	efbd2179-5f6d-a8c6-e053-2a95a90a17e7	2023-10-18	Warnings	Exact identifier application number: M020
Vanilla Mint Broad Spectrum SPF 15 Lip Moisturizer	VANILLA MINT SPF 15 BROAD SPECTRUM LIP MOISTURIZER	Raining Rose, Inc	af10a007-6597-2231-e053-2995a90a8717	2023-10-18	Warnings	Exact identifier application number: M020
Mint Broad Spectrum SPF 15 Lip Moisturizer	MINT SPF 15 BROAD SPECTRUM LIP MOISTURIZER	Raining Rose, Inc	af471721-54e4-0738-e053-2a95a90a7e12	2023-10-18	Warnings	Exact identifier application number: M020
Spearmint SPF 15 Broad Spectrum Lip Balm	SPEARMINT SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a9029e6d-7443-efe2-e053-2995a90a8125	2023-10-18	Warnings	Exact identifier application number: M020
Watermelon Twist SPF 15 Broad Spectrum Lip Balm	WATERMELON TWIST SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a903a7cc-0de5-5adc-e053-2a95a90aa961	2023-10-18	Warnings	Exact identifier application number: M020
Vanilla Mint SPF 15 Broad Spectrum Lip Balm	VANILLA MINT SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a9031b15-d2b0-d248-e053-2a95a90a65ff	2023-10-18	Warnings	Exact identifier application number: M020
Cherry SPF 15 Broad Spectrum Lip Balm	CHERRY SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a75a7326-aaa4-767b-e053-2995a90adf16	2023-10-18	Warnings	Exact identifier application number: M020
Wildberry SPF 15 Broad Spectrum Lip Balm	WILDBERRY SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a903c855-867b-4f14-e053-2a95a90a5333	2023-10-18	Warnings	Exact identifier application number: M020
Tropical SPF 15 Broad Spectrum Lip Balm	TROPICAL SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a903202b-1dc6-85ad-e053-2995a90a4ab8	2023-10-18	Warnings	Exact identifier application number: M020
Pomegranate SPF 15 Broad Spectrum Lip Balm	POMEGRANATE SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a901e45d-2ea6-bae8-e053-2a95a90afc98	2023-10-18	Warnings	Exact identifier application number: M020
Vanilla SPF 15 Broad Spectrum Lip Balm	VANILLA SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a903a7cc-0dd5-5adc-e053-2a95a90aa961	2023-10-18	Warnings	Exact identifier application number: M020
Raspberry SPF 15 Broad Spectrum Lip Balm	RASPBERRY SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a902917c-b8fb-b2d0-e053-2995a90a42db	2023-10-18	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