SHISEIDO SUN PROTECTION

Product NDC: 58411-161
11-digit product format: 584110161
Labeler code: 58411
Product ID: 58411-161_7cf0eda6-d340-0a25-e053-2991aa0ad38a
Type: HUMAN OTC DRUG
Nonproprietary name: OCTINOXATE and TITANIUM DIOXIDE
Dosage form: STICK
Route: TOPICAL
Labeler: SHISEIDO AMERICAS CORPORATION
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2014-04-01
Marketing end: 0000-00-00
Substance: OCTINOXATE; TITANIUM DIOXIDE
Active strength: 441 mg/9g; mg/9g
NDC exclude flag: No
Listing certified through: 2019-12-31
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	58411-161		D	Discontinued by firm		2026-10-15
excluded package	package	58411-161	58411-161-20	D	Discontinued by firm		2026-10-15

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 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58411-161-20	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58411-161-20	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58411-161-20	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58411-161-20	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58411-161-20	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58411-161-20	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58411-161-20	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58411-161-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58411-161-20	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58411-161-20	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	58411-161-20	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	58411-161-20	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	58411-161-20	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	58411-161-20	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	58411-161-20	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	58411-161-20	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	58411-161-20	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	58411-161-20	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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
58411-161-20	2023-12-16	C162847	48780-1	9d75b9d0-4096-f424-e053-dadaa90a57ce	SHISEIDO SUN PROTECTION
58411-161-20	2020-01-31	C162847	48780-1	9d75b9d0-4096-f424-e053-dadaa90a57ce	SHISEIDO SUN PROTECTION

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	SHISEIDO SUN PROTECTION (OCTINOXATE AND TITANIUM DIOXIDE) STICK [SHISEIDO AMERICAS CORPORATION]	1
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	SHISEIDO SUN PROTECTION (OCTINOXATE AND TITANIUM DIOXIDE) STICK [SHISEIDO AMERICAS CORPORATION]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	SHISEIDO SUN PROTECTION (OCTINOXATE AND TITANIUM DIOXIDE) STICK [SHISEIDO AMERICAS CORPORATION]	1
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	SHISEIDO SUN PROTECTION (OCTINOXATE AND TITANIUM DIOXIDE) STICK [SHISEIDO AMERICAS CORPORATION]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	SHISEIDO SUN PROTECTION (OCTINOXATE AND TITANIUM DIOXIDE) STICK [SHISEIDO AMERICAS CORPORATION]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	SHISEIDO SUN PROTECTION (OCTINOXATE AND TITANIUM DIOXIDE) STICK [SHISEIDO AMERICAS CORPORATION]	1
BARIUM SULFATE	INACTIVE INGREDIENT	25BB7EKE2E	SHISEIDO SUN PROTECTION (OCTINOXATE AND TITANIUM DIOXIDE) STICK [SHISEIDO AMERICAS CORPORATION]	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	SHISEIDO SUN PROTECTION (OCTINOXATE AND TITANIUM DIOXIDE) STICK [SHISEIDO AMERICAS CORPORATION]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	SHISEIDO SUN PROTECTION (OCTINOXATE AND TITANIUM DIOXIDE) STICK [SHISEIDO AMERICAS CORPORATION]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	SHISEIDO SUN PROTECTION (OCTINOXATE AND TITANIUM DIOXIDE) STICK [SHISEIDO AMERICAS CORPORATION]	1
DIPHENYLSILOXY PHENYL TRIMETHICONE	INACTIVE INGREDIENT	I445L28B12	SHISEIDO SUN PROTECTION (OCTINOXATE AND TITANIUM DIOXIDE) STICK [SHISEIDO AMERICAS CORPORATION]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SHISEIDO SUN PROTECTION (OCTINOXATE AND TITANIUM DIOXIDE) STICK [SHISEIDO AMERICAS CORPORATION]	1
HIGH DENSITY POLYETHYLENE	INACTIVE INGREDIENT	UG00KM4WR7	SHISEIDO SUN PROTECTION (OCTINOXATE AND TITANIUM DIOXIDE) STICK [SHISEIDO AMERICAS CORPORATION]	1
HYDROGENATED POLYDECENE (550 MW)	INACTIVE INGREDIENT	U333RI6EB7	SHISEIDO SUN PROTECTION (OCTINOXATE AND TITANIUM DIOXIDE) STICK [SHISEIDO AMERICAS CORPORATION]	1
KAOLIN	INACTIVE INGREDIENT	24H4NWX5CO	SHISEIDO SUN PROTECTION (OCTINOXATE AND TITANIUM DIOXIDE) STICK [SHISEIDO AMERICAS CORPORATION]	1
METHICONE (20 CST)	INACTIVE INGREDIENT	6777U11MKT	SHISEIDO SUN PROTECTION (OCTINOXATE AND TITANIUM DIOXIDE) STICK [SHISEIDO AMERICAS CORPORATION]	1
MICA	INACTIVE INGREDIENT	V8A1AW0880	SHISEIDO SUN PROTECTION (OCTINOXATE AND TITANIUM DIOXIDE) STICK [SHISEIDO AMERICAS CORPORATION]	1
MICROCRYSTALLINE WAX	INACTIVE INGREDIENT	XOF597Q3KY	SHISEIDO SUN PROTECTION (OCTINOXATE AND TITANIUM DIOXIDE) STICK [SHISEIDO AMERICAS CORPORATION]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SHISEIDO SUN PROTECTION (OCTINOXATE AND TITANIUM DIOXIDE) STICK [SHISEIDO AMERICAS CORPORATION]	1
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	SHISEIDO SUN PROTECTION (OCTINOXATE AND TITANIUM DIOXIDE) STICK [SHISEIDO AMERICAS CORPORATION]	1
STEARYL GLYCYRRHETINATE	INACTIVE INGREDIENT	3YYE6VJS0P	SHISEIDO SUN PROTECTION (OCTINOXATE AND TITANIUM DIOXIDE) STICK [SHISEIDO AMERICAS CORPORATION]	1
THIOTAURINE	INACTIVE INGREDIENT	NQZ2D7AO62	SHISEIDO SUN PROTECTION (OCTINOXATE AND TITANIUM DIOXIDE) STICK [SHISEIDO AMERICAS CORPORATION]	1
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	SHISEIDO SUN PROTECTION (OCTINOXATE AND TITANIUM DIOXIDE) STICK [SHISEIDO AMERICAS CORPORATION]	1
TRIETHOXYCAPRYLYLSILANE	INACTIVE INGREDIENT	LDC331P08E	SHISEIDO SUN PROTECTION (OCTINOXATE AND TITANIUM DIOXIDE) STICK [SHISEIDO AMERICAS CORPORATION]	1
TRIETHYLHEXANOIN	INACTIVE INGREDIENT	7K3W1BIU6K	SHISEIDO SUN PROTECTION (OCTINOXATE AND TITANIUM DIOXIDE) STICK [SHISEIDO AMERICAS CORPORATION]	1
ZINC MYRISTATE	INACTIVE INGREDIENT	K09A9E2GGO	SHISEIDO SUN PROTECTION (OCTINOXATE AND TITANIUM DIOXIDE) STICK [SHISEIDO AMERICAS CORPORATION]	1

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SHISEIDO SUN PROTECTION	SHISEIDO AMERICAS CORPORATION \| SHISEIDO AMERICA INC.	2018-12-13	HUMAN OTC DRUG LABEL	2

SHISEIDO SUN PROTECTION

NDC auxiliary status#

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Related DailyMed Labels#