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 50 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sky and Sol Face and Body Sunscreen SPF 50	NON- NANO ZINC OXIDE	Delta Ecommerce LLC	473a6ade-1f0a-c711-e063-6294a90a2b83	2026-03-30	Warnings	Exact identifier application number: M020
Vacation by Vacation Scent and Shimmer Duo	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Vacation Inc.	0c4e6fa1-c78d-4f9d-969f-135d4ed67daf	2026-03-30	Warnings	Exact identifier application number: M020
Marie originals - ProActive Sunscreen	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	4e3204bf-eda4-2bdf-e063-6394a90ae429	2026-03-29	Warnings	Exact identifier application number: M020
Sport Ultra	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CARDINAL HEALTH 110, LLC. DBA LEADER	37c5dcf7-dc2d-624f-e063-6394a90ae992	2026-03-29	Warnings	Exact identifier application number: M020
ULTRALIGHT AGE DEFENSE SPF 50	ZINC OXIDE	Guangzhou Origin Beauty Cosmetics Co., Ltd.	4e36a743-7906-2b7b-e063-6294a90af314	2026-03-29	Warnings	Exact identifier application number: M020
Stay Put Sunscreen SPF 30	OCTINOXATE 7.50% OCTISALATE 5.00% OXYBENZONE 4.00% HOMOSALATE 10.00%	Sawyer Products Inc	7ecba495-a912-4697-8287-2e5836e610e1	2026-03-27	Warnings	Exact identifier application number: M020
UV SOLUTIONS BRIGHTENING TINTED BROAD SPECTRUM SPF 50 SUNSCREEN NIACINAMIDE ANTIOXIDANTS DARK SHADE	TITANIUM DIOXIDE AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	4e0bd355-99c6-8cf4-e063-6294a90ab4b3	2026-03-27	Warnings	Exact identifier application number: M020
Vacation X AZ Lemon Tea Lip Balm SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Vacation INC.	61c48acc-f589-40d3-b289-b777db5551db	2026-03-27	Warnings	Exact identifier application number: M020
Truly Solar Baby Suncreen SPF 45	HOMOSALATE 15% OCTISALATE 5% OCTOCRYLENE 10% AVOBENZONE 3%	Truly Beauty, Inc	38e6c6fc-d8b9-4196-96c7-0f6d5d06da02	2026-03-26	Warnings	Exact identifier application number: M020
burnd	HOMOSALATE, OCTINOXATE, ZINC OXIDE	BURND LLC	31cf923e-fdde-790b-e063-6294a90a60ee	2026-03-26	Warnings	Exact identifier application number: M020
SUNNYSIDEKICK UVA/UVB Broad Spectrum SPF 30 Brush-On Mineral	ZINC OXIDE, TITANIUM DIOXIDE	Classic Cosmetics LLC	4df3b8c0-71bc-acdd-e063-6394a90a35c0	2026-03-26	Warnings	Exact identifier application number: M020
COSRX	VITAMIN E VITALIZING SUNSCREEN	COSRX inc.	4df77564-9da0-7e48-e063-6294a90a5e6b	2026-03-26	Warnings	Exact identifier application number: M020
Mentholatum Natural Ice Protect Plus SPF 30 Protect Plus SPF 30	AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTISALATE	The Mentholatum Company	3804a14b-be7c-a973-e063-6294a90ac7fc	2026-03-25	Warnings	Exact identifier application number: M020
Softlips Oasis Pineapple Coconut	DIMETHICONE, OXYBENZONE, OCTINOXATE	The Mentholatum Company	c504463a-28bf-4161-875f-ef73520931c5	2026-03-25	Warnings	Exact identifier application number: M020
Mentholatum Natural Ice Cherry, SPF 15 Cherry	DIMETHICONE, OCTINOXATE, OCTISALATE	The Mentholatum Company	37f2c3a6-7790-c8ec-e063-6294a90ace22	2026-03-25	Warnings	Exact identifier application number: M020
Mentholatum Natural Ice - Original, SPF 15 Original	DIMETHICONE, OCTINOXATE, OCTISALATE	The Mentholatum Company	37dc44aa-17b2-8721-e063-6294a90a34f6	2026-03-25	Warnings	Exact identifier application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGEL	AVOBENZONE, HOMOSALATE, OCTISALATE	ISNTREE Inc.	0ef5d5ce-3bdf-dffc-e063-6394a90aad54	2026-03-25	Warnings	Exact identifier application number: M020
Silkscreen Sheer Tint Mineral Light-Medium	TITANIUM DIOXIDE, ZINC OXIDE	Curology	4ddbe349-6880-a5fc-e063-6294a90a275c	2026-03-25	Warnings	Exact identifier application number: M020
AXIS-Y Complete No-Stress Physical Sunscreen V.3	ZINC OXIDE	Asia Master Trade Co.,Ltd	1f310fb1-185a-b467-e063-6294a90a72fe	2026-03-25	Warnings	Exact identifier application number: M020
BANANA BOAT	TITANIUM DIOXIDE,ZINC OXIDE	Edgewell Personal Care Brands LLC	4e0450ca-147a-91d7-e063-6394a90ae73b	2026-03-25	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