SHISEIDO SPORTS BB

Product NDC: 58411-452
11-digit product format: 584110452
Labeler code: 58411
Product ID: 58411-452_47a94a6a-78b4-6604-e063-6394a90a1060
Type: HUMAN OTC DRUG
Nonproprietary name: OCTINOXATE and TITANIUM DIOXIDE
Dosage form: LOTION
Route: TOPICAL
Labeler: SHISEIDO AMERICAS CORPORATION
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-02-01
Substance: OCTINOXATE; TITANIUM DIOXIDE
Active strength: 1815; 5558 mg/30mL; mg/30mL
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 · 18 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
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	58411-452-10	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	58411-452-10	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	58411-452-10	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	58411-452-10	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	58411-452-10	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	58411-452-10	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	58411-452-10	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	58411-452-10	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	58411-452-10	I	Inactivated by FDA	`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: SHISEIDO SPORTS BB
Brand name suffix: DARK
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTINOXATE	1815 mg/30mL
TITANIUM DIOXIDE	5558 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4Y5P7MUD51	Internal UNII lookup
15FIX9V2JP	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
260a3eab-8fe6-4259-8dcc-3706ca1f6881	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58411-452-10	2023-12-29	C162847	48780-1	9d75b9d0-1d0b-f424-e053-dadaa90a57ce	SHISEIDO SPORTS BB
58411-452-10	2020-01-31	C162847	48780-1	9d75b9d0-1d0b-f424-e053-dadaa90a57ce	SHISEIDO SPORTS BB

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58411-452-10	SHISEIDO SPORTS BBDARK	30 mL in 1 CONTAINER	LOTION	30		4
58411-452-10	SHISEIDO SPORTS BBDARK	1 in 1 CARTON	LOTION	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58411-452	SHISEIDO SPORTS BB LIGHT (OCTINOXATE AND TITANIUM DIOXIDE) LOTION SHISEIDO SPORTS BB MEDIUM (OCTINOXATE AND TITANIUM DIOXIDE) LOTION SHISEIDO SPORTS BB DARK (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]	3	Current NDC, Legacy NDC, 2 package rows	20241228_260a3eab-8fe6-4259-8dcc-3706ca1f6881.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 80 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dr. C. Tuna Sun Stick SPF 50	AVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENE	TAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI	fc89d1b5-1ffe-4f06-8c5c-31f2eb0b5641	2026-01-14	Warnings	Exact identifier application number: M020
Oiana Mineral Sunscreen Drops	ZINC OXIDE	Oiana LLC	4860257d-a8bf-7ce5-e063-6394a90a74db	2026-01-14	Warnings	Exact identifier application number: M020
Standard Procedure Lip Balm SPF 50	ZINC OXIDE HOMOSALATE OCTOCRYLENE	Standard Procedure Inc	1e3db995-b1c5-3a2e-e063-6294a90af75e	2026-01-14	Warnings	Exact identifier application number: M020
Standard Procedure SPF 50 Sunscreen	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Standard Procedure Inc	1d3f87de-90c0-75c0-e063-6394a90a2ef4	2026-01-14	Warnings	Exact identifier application number: M020
EELHOE Bio Sun Stick	TITANIUM DIOXIDE	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	48654406-505b-518b-e063-6394a90a5add	2026-01-14	Warnings	Exact identifier application number: M020
JAYSUING Hyaluronic Acid Moisturizing Sunscreen	TITANIUM DIOXIDE	Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.	48662fae-2d41-4a4a-e063-6394a90a1522	2026-01-14	Warnings	Exact identifier application number: M020
CALIFORNIA ALOE FRESH POW DERY SUN	HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE	NATURE REPUBLIC CO., LTD.	aa10dbbf-97b3-4258-bbd3-0d8cc9935e12	2026-01-13	Warnings	Exact identifier application number: M020
COSRX	VITAMIN E VITALIZING SUNSCREEN	COSRX inc.	4840f608-944a-3e3d-e063-6394a90a1d9d	2026-01-13	Warnings	Exact identifier application number: M020
Neutrogena Invisible Daily Defense Face Serum Sunscreen Broad Spectrum SPF 60 Plus	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	b043f0f3-b263-4c49-86ca-9ecc71a22aa8	2026-01-13	Warnings	Exact identifier application number: M020
ARAMORE MULTI-DEFENSE SUNSCREEN - AM Broad Spectrum SPF 30	ZINC OXIDE	New Frontier Bio, Inc	ef6c8443-fd10-2022-e053-2a95a90a45ea	2026-01-13	Warnings	Exact identifier application number: M020
Bluevado Sunfix	ZINC OXIDE, TITANIUM DIOXIDE	Magic Blue, LLC	2e5315bf-39f4-401c-8207-18ef6a97e024	2026-01-13	Warnings	Exact identifier application number: M020
Intellishade TruPhysical SPF 45	TITANIUM DIOXIDE, ZINC OXIDE	Revision, LLC	e20f5dc9-e863-b090-e053-2a95a90a5044	2026-01-13	Warnings	Exact identifier application number: M020
Intellishade TruPhysical Clear SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Revision, LLC	1305fa94-47d5-7a42-e063-6394a90a0aba	2026-01-13	Warnings	Exact identifier application number: M020
Intellishade Clear SPF 50	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE	Revision, LLC	e213b46d-d061-dc83-e053-2995a90ad875	2026-01-13	Warnings	Exact identifier application number: M020
Intellishade Matte SPF 45	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	Revision, LLC	e213ae87-4db2-3070-e053-2995a90a083b	2026-01-13	Warnings	Exact identifier application number: M020
Sun Project Moisture	HOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATE, OCTOCRYLENE, BUTYL METHOXYDIBENZOYLMETHANE	THANK YOU FARMER CO., LTD	20a83f02-d851-4aac-e063-6394a90ae1a6	2026-01-13	Warnings	Exact identifier application number: M020
THANK YOU FARMER Sun Project Soothing	HOMOSALATE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE	THANK YOU FARMER CO., LTD	20a60051-d57c-a341-e063-6394a90a9243	2026-01-13	Warnings	Exact identifier application number: M020
Sun Guard	ZINC OXIDE	Saje Natural Business Inc	87ee593d-668c-f592-e053-2a95a90a17b1	2026-01-13	Warnings	Exact identifier application number: M020
Vixin Beach Face Sunscreen SPF50	ZINC OXIDE	Veganic SKN Limited	482ae347-d175-52f2-e063-6394a90a92b0	2026-01-12	Warnings	Exact identifier application number: M020
FRE Glow ME Lightweight Tinted Moisturizer	ZINC OXIDE	Peer Pharm Ltd	1cf5b24a-e6fd-470a-e063-6294a90ab29c	2026-01-12	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	Units	Marketing start	Sample	Exclude flag	Status
58411-452-10	58411045210	1 CONTAINER in 1 CARTON (58411-452-10) / 30 mL in 1 CONTAINER	1 container	2019-02-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SHISEIDO SPORTS BB	SHISEIDO AMERICAS CORPORATION \| Shiseido America Inc.	2026-01-05	HUMAN OTC DRUG LABEL	4