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 89 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	228055ec-ff59-4412-e063-6394a90abe14	2026-01-05	Warnings	Exact identifier application number: M020
SHISEIDO UV PROTECTIVE FOUNDATION FAIR IVORY	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	236bdb53-d7a5-43a2-8a0c-bce4a5522e26	2026-01-05	Warnings	Exact identifier application number: M020
SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAY	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE	SHISEIDO AMERICAS CORPORATION	4bd99626-690b-49e8-8c42-a2e2dbca09bf	2026-01-05	Warnings	Exact identifier application number: M020
cle de peau BEAUTE LONG-LASTING HYDRATING VEIL	AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE	SHISEIDO AMERICAS CORPORATION	f04ece6c-66b6-48e9-8f6b-e898a538ba00	2026-01-05	Warnings	Exact identifier application number: M020
cle de peau BEAUTE RADIANT FOUNDATION N I10	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	05ffb157-5e28-4e94-866d-9e3371480d84	2026-01-05	Warnings	Exact identifier application number: M020
cle de peau BEAUTE CONCEALER N 1	TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	eedf8065-8897-4773-9cbb-bab57d2dd04f	2026-01-05	Warnings	Exact identifier application number: M020
cle de peau BEAUTE BRIGHTENING ENHANCER VEIL	OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	bb00d6d7-cc51-4fee-a0df-68bbd5bc50d6	2026-01-05	Warnings	Exact identifier application number: M020
cle de peau BEAUTE THE FOUNDATION N I10 VERY LIGHT IVORY	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	beefe840-6f32-483b-8a37-2696adb8eea1	2026-01-05	Warnings	Exact identifier application number: M020
cle de peau BEAUTE PROTECTIVE LIP TREATMENT SPF 25	AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE	SHISEIDO AMERICAS CORPORATION	addd9885-362c-4ce0-9a6e-759e71d8756c	2026-01-05	Warnings	Exact identifier application number: M020
cle de peau BEAUTE PROTECTIVE FORTIFYING n	AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE	SHISEIDO AMERICAS CORPORATION	65ca1240-6ee8-40c0-b62f-3597e0872c6e	2026-01-05	Warnings	Exact identifier application number: M020
cle de peau BEAUTE CORRECTING VEIL n M	ENSULIZOLE, OCTINOXATE, AND ZINC OXIDE	SHISEIDO AMERICAS CORPORATION	15a258a0-61c3-4419-bcdb-a8197d5ae46f	2026-01-05	Warnings	Exact identifier application number: M020
Dominas Dark Spot UV Defense Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG H&H Co.,Ltd.	098c0a9b-2b96-6be3-e063-6294a90a959a	2026-01-05	Warnings	Exact identifier application number: M020
Poolside Butter Screen SPF 30 Sunscreen Butter	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	ae838725-79ab-4c17-905b-d4138ad6af1f	2026-01-05	Warnings	Exact identifier application number: M020
Poolside Bronze Service Instant Bronzing Sunscreen SPF 30	HOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONE	I World LLC	b98a9cec-3c48-4614-b091-4e59fa7d196e	2026-01-05	Warnings	Exact identifier application number: M020
Poolside Orange Creme SPF 30 Sunscreen Oil Mist	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	5a9f8888-529d-40d7-9489-baa5ff657cb4	2026-01-05	Warnings	Exact identifier application number: M020
Yon-Ka 50 Mineral Fluid	ZINC OXIDE	Laboratoire MULTALER Yon-Ka	47a8c8b2-30ff-0d40-e063-6294a90ac461	2026-01-05	Warnings	Exact identifier application number: M020
SHISEIDO FUTURE solution LX UNIVERSAL DEFENSE E	OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE	SHISEIDO AMERICAS CORPORATION	6d2f82d5-b3af-44af-b6b0-de96a4cd95fc	2026-01-05	Warnings	Exact identifier application number: M020
SHISEIDO SPORTS BB LIGHT	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	260a3eab-8fe6-4259-8dcc-3706ca1f6881	2026-01-05	Warnings	Exact identifier application number: M020 ndc (product): 58411-452
SHISEIDO VITAL PERFECTION UPLIFTING AND FIRMING DAY	AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND HOMOSALATE	SHISEIDO AMERICAS CORPORATION	4a16dbb7-e860-4aae-8e8b-67abbe8295bd	2026-01-05	Warnings	Exact identifier application number: M020
SHISEIDO ULTIMATE SUN PROTECTOR	OCTISALATE, TITANIUM DIOXIDE, OCTOCRYLENE, AND ZINC OXIDE	SHISEIDO AMERICAS CORPORATION	c656792a-e1ed-478d-b501-9bdc92d16eca	2026-01-05	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