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
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
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 14 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
UV RESTORE FACE SERUM SUNSCREEN SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	COSMAX USA	564b8070-ee59-0c24-e063-6294a90ad9a9	2026-07-10	Warnings	Exact identifier application number: M020
COCO-EVE COCONUT MILK BODY SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COSMAX USA	564b80c2-16e0-fb5f-e063-6394a90a50d2	2026-07-10	Warnings	Exact identifier application number: M020
COCO EVE SUNNY HONEY HIGHLIGHTER BODY SPF 50	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	COSMAX USA	564b9b1f-3d5b-4349-e063-6294a90a3b77	2026-07-10	Warnings	Exact identifier application number: M020
NORWEX Lip Glaze Broad Spectrum SPF 30 Hazelnut	ZINC OXIDE	COSMAX USA	564ba912-c44b-4940-e063-6294a90a28fa	2026-07-10	Warnings	Exact identifier application number: M020
MISTINE UV INVISIBLE FACE SHEER SUNSCREEN SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COSMAX USA	564bbb5f-4000-390d-e063-6294a90a408d	2026-07-10	Warnings	Exact identifier application number: M020
PEACH AND LILY SUN COVER MINERAL SUNSCREEN SPF 30	ZINC OXIDE	COSMAX USA	564bb5f9-5ac5-548b-e063-6394a90a8462	2026-07-10	Warnings	Exact identifier application number: M020
ILLUSION LUMINOUS GLOW FOUNDATION	AVOBENZONE, HOMOSALATE, AND OCTISALATE	Kingdom Animalia, LLC DBA Hourglass Cosmetics	cf6a7e1a-7bca-439c-808a-80262f095f84	2026-07-10	Warnings	Exact identifier application number: M020
Tula Skincare Protect and Glow Daily Facial Sunscreen Gel SPF 30	AVOBENZONE, HOMOSALATE, AND OCTISALATE	The Procter & Gamble Manufacturing Company	30a063fa-e537-a2c1-e063-6394a90a6a83	2026-07-09	Warnings	Exact identifier application number: M020
Olay Complete Lightweight with Sunscreen Broad Spectrum SPF 15 Sensitive	OCTINOXATE AND ZINC OXIDE	The Procter & Gamble Manufacturing Company	3cb971e1-34f1-ee89-e063-6394a90a52a9	2026-07-09	Warnings	Exact identifier application number: M020
Olay Complete Lightweight with Sunscreen Broad Spectrum SPF 30 Sensitive	OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE	The Procter & Gamble Manufacturing Company	3cb9de81-f05e-9697-e063-6394a90a69c5	2026-07-09	Warnings	Exact identifier application number: M020
Bombee Honey Daily Glow Shield Sunscreen	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE	ABT ASIA Inc.	56112dff-b091-7a56-e063-6294a90a77d3	2026-07-08	Warnings	Exact identifier application number: M020
Sunny C Sunscreen SPF 50	SUNNY C SUNSCREEN	MIXIK, INC.	4ed2a482-6c63-69f5-e063-6394a90ad3ee	2026-07-08	Warnings	Exact identifier application number: M020
Ultra Violette Supreme Screen Broad Spectrum SPF 50	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Grace and Fire USA Inc.	24389324-19db-7eb5-e063-6394a90ad7fb	2026-07-08	Warnings	Exact identifier application number: M020
ANEW ULTIMATE DAY MULTI-PERFORMANCECREAM SPF 25 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTINOXATE,OXYBENZONE	COSMAX USA, CORPORATION	562053d4-12bd-976e-e063-6394a90a59de	2026-07-08	Warnings	Exact identifier application number: M020
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	DERMIO DERMATOLOGY LLC	562f5b0d-6a10-305d-e063-6394a90a5980	2026-07-08	Warnings	Exact identifier application number: M020
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	Suzanne's Skin2soul LLC	562fbaa6-f93a-5ec4-e063-6294a90a9634	2026-07-08	Warnings	Exact identifier application number: M020
Sun Protection Mineral SPF 30	ZINC OXIDE	derma e	bf6474a7-a21f-49cb-86e6-e5c40dbd34c3	2026-07-08	Warnings	Exact identifier application number: M020
Aussie Betta Tallow Sunscreen SPF50 SPF50	TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREEN	AUSSIE BETTA HEALTHY CARE PTY LTD	56007d82-ff5b-6c26-e063-6294a90a09b6	2026-07-07	Warnings	Exact identifier application number: M020
Bath and Body Works SPF Pink Dream	AVOBENZONE,HOMOSALATE,OCTISALATE	Bath & Body Works, Inc.	560785f5-9126-12ba-e063-6294a90ac946	2026-07-07	Warnings	Exact identifier application number: M020
Bath and Body Works SPF Sunkissed Berry	AVOBENZONE,HOMOSALATE,OCTISALATE	Bath & Body Works, Inc.	56078698-8655-12bd-e063-6294a90ad34c	2026-07-07	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