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 93 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Coppertone Oil Free SPF 50 Sunscreen	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 8%	Beiersdorf Inc	ded1f158-36d1-153f-e053-2995a90ace30	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Pure and Simple Kids Suncreen SPF 50	ZINC OXIDE 24.08%	Beiersdorf Inc	08147940-0e8b-c894-e063-6394a90af8ac	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 70	AVOBENZONE 3%, HOMOSALATE 13%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%	Beiersdorf Inc	e468d703-fa6c-095a-e053-2a95a90a5194	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50	ZINC OXIDE 24.08%	Beiersdorf Inc	0806bdb9-961f-3146-e063-6294a90a4625	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPL 15	AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%	Beiersdorf Inc	df4b522e-93d4-1284-e053-2a95a90a1cd9	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Pure and Simple Baby Sunscreen SPF 50	ZINC OXIDE 24.08%	Beiersdorf Inc	088b7152-d3d1-9e74-e063-6394a90a4152	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 50	(TO DELIVER) AVOBENZONE 3%, HOMOSALATE 10%,OCTISALATE 5%, OCTOCRYLENE 5%	Beiersdorf Inc	0a5a40ff-a014-3995-e063-6394a90a11e6	2025-12-31	Warnings	Exact identifier application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Deep	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47461ad3-a11e-2a11-e063-6294a90a0f8f	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Oil Free Sunscreen SPF 30	AVOBENZONE 3%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 6%	Beiersdorf Inc	e451ecfb-cf17-c622-e053-2a95a90a4d4b	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Pure and Simple Sunscreen SPF 50	ZINC OXIDE 24.08%	Beiersdorf Inc	081484f8-58f5-f2a4-e063-6394a90a3379	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Pure and Simple Kids Sunscreen SPF 50	ZINC OXIDE (24.08%)	Beiersdorf Inc	09a97e3f-f6dc-eaa7-e063-6294a90ad274	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Kids Roll-On Sunscreen SPF 50	ZINC OXIDE 24.08%	Beiersdorf Inc	f3e1ea21-4a07-3e18-e053-2995a90a0fe7	2025-12-31	Warnings	Exact identifier application number: M020
Eucerin Sensitive Mineral Face Sunscreen SPF 35	ZINC OXIDE 24%	Beiersdorf Inc	f3a8bb6b-f051-5d39-e053-2a95a90adafc	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Limited Edition Sunscreen SPF 30	AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%	Beiersdorf Inc	f41e09bf-407d-65a4-e053-2a95a90a2436	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Glow Hydragel SPF 50	AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%	Beiersdort Inc	b5f7cacb-92b9-a6b7-e053-2a95a90aea02	2025-12-31	Warnings	Exact identifier application number: M020
Eucerin Advanced Hydration Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Beiersdorf Inc	cd6112fe-89e4-a79b-e053-2a95a90ad7f4	2025-12-31	Warnings	Exact identifier application number: M020
Eucerin Age Defense SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Beiersdort Inc	cd9d4f30-fb37-9935-e053-2995a90a9936	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 70	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%	Beiersdorf Inc	cc5d1f9b-2c8a-1392-e053-2a95a90acb9e	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Every Tone Brightening Sunscreen SPF 60	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdorf Inc	23e368db-4b2f-d23b-e063-6394a90a1f06	2025-12-31	Warnings	Exact identifier application number: M020
Eucerin Advanced Hydration Ultra-Light Face Sunscreen SPF 50	AVOBENZENE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdorf Inc	25d9c520-431a-5546-e063-6394a90a4e0d	2025-12-31	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