SHISEIDO ULTIMATE SUN PROTECTOR

Product NDC: 58411-480
11-digit product format: 584110480
Labeler code: 58411
Product ID: 58411-480_47a95b3e-c698-9007-e063-6394a90afe66
Type: HUMAN OTC DRUG
Nonproprietary name: OCTISALATE, TITANIUM DIOXIDE, OCTOCRYLENE, and ZINC OXIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: SHISEIDO AMERICAS CORPORATION
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-01-01
Substance: OCTISALATE; TITANIUM DIOXIDE; OCTOCRYLENE; ZINC OXIDE
Active strength: 3.105; 2.359; 4.347; 12.047 g/50mL; g/50mL; g/50mL; g/50mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 ULTIMATE SUN PROTECTOR
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTISALATE	3.105 g/50mL
TITANIUM DIOXIDE	2.359 g/50mL
OCTOCRYLENE	4.347 g/50mL
ZINC OXIDE	12.047 g/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4X49Y0596W	Internal UNII lookup
15FIX9V2JP	Internal UNII lookup
5A68WGF6WM	Internal UNII lookup
SOI2LOH54Z	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
c656792a-e1ed-478d-b501-9bdc92d16eca	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58411-480-60	SHISEIDO ULTIMATE SUN PROTECTOR	1 in 1 CARTON	CREAM	1		3
58411-480-60	SHISEIDO ULTIMATE SUN PROTECTOR	50 mL in 1 TUBE	CREAM	50		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58411-480	SHISEIDO ULTIMATE SUN PROTECTOR (OCTISALATE, TITANIUM DIOXIDE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICAS CORPORATION]	2	Current NDC, Legacy NDC, 2 package rows	20241225_c656792a-e1ed-478d-b501-9bdc92d16eca.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 23 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ultra Violette Preen Screen Broad Spectrum SPF 50	AVONBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Grace and Fire USA Inc.	26a0fc0d-a903-2ac1-e063-6394a90a13db	2026-06-01	Warnings	Exact identifier application number: M020
Timesavvy Hybrid XL Cushion Sun Serum SPF 50	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	ProBetter USA, Inc.	82a22071-f1bd-4fab-b929-8a00ef18f0d9	2026-05-31	Warnings	Exact identifier application number: M020
Marine Screen Mineral Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	OSEA International, LLC	9aa20377-0ab9-4205-b9aa-24640a4641e7	2026-05-29	Warnings	Exact identifier application number: M020
Ciele Blush and Protect Sugar	ZINC OXIDE	Ciele LLC	52f3a9f6-a226-6723-e063-6394a90a8706	2026-05-29	Warnings	Exact identifier application number: M020
KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN MINER ALL UV SERUM BROAD SPECTRUM SPF 50 PLUS MINERAL SUNSCREEN	TITANIUM DIOXIDE AND ZINC OXIDE	LOreal USA Products Inc	294e6049-12b5-4b45-ae00-8ee1d9d2a1a4	2026-05-29	Warnings	Exact identifier application number: M020
Daily Mineral Sunscreen 20% Zinc Oxide	ZINC OXIDE	INTEGRATIVE AESTHETICS BOSTON, LLC	52f818f4-8485-b228-e063-6294a90a9fe3	2026-05-29	Warnings	Exact identifier application number: M020
Dr.G BRIGHT TONING UP TINTED SUNSCREEN	ZINC OXIDE, OCTISALATE, HOMOSALATE	GOWOONSESANG COSMETICS CO., LTD.	30d34459-b7fb-b0c6-e063-6294a90a08ac	2026-05-28	Warnings	Exact identifier application number: M020
Dr.G GREEN MILD UP DEFENSE MINERAL SUNSCREEN	ZINC OXIDE	GOWOONSESANG COSMETICS CO., LTD.	30d49f24-3e13-385f-e063-6294a90ab5c8	2026-05-28	Warnings	Exact identifier application number: M020
Dr.G R.E.D BLEMISH SOOTHING UP MOISTURE SUNSCREEN	HOMOSALATE, OCTISALATE, AVOBENZONE	GOWOONSESANG COSMETICS CO., LTD.	30d53b8a-7e35-0b2b-e063-6294a90aa8df	2026-05-28	Warnings	Exact identifier application number: M020
Ciele Blush and Protect Berri	ZINC OXIDE	Ciele LLC	52e16cbc-b452-db18-e063-6394a90a4081	2026-05-28	Warnings	Exact identifier application number: M020
Ciele Blush and Protect June	ZINC OXIDE	Ciele LLC	52e1c504-f0ee-2853-e063-6394a90a3139	2026-05-28	Warnings	Exact identifier application number: M020
Ciele Blush and Protect January	ZINC OXIDE	Ciele LLC	52e186df-06aa-6528-e063-6294a90a3888	2026-05-28	Warnings	Exact identifier application number: M020
Ciele Blush and Protect Berri	ZINC OXIDE	Ciele LLC	52e1398d-b170-ea89-e063-6294a90a7d24	2026-05-28	Warnings	Exact identifier application number: M020
TIZO ULTRA NON TINTED MINERAL SUNSCREEN	ZINC OXIDE 20%	Fallien Cosmeceuticals, LTD	30d30610-2e6c-418c-bbcf-4ecd7f61be93	2026-05-28	Warnings	Exact identifier application number: M020
Creme Foundation	ZINC OXIDE	Lauren Brooke Cosmetiques LLC	4d09907e-ddcd-9d62-e063-6394a90acf3f	2026-05-28	Warnings	Exact identifier application number: M020
GOONGBE Moisture Sun Cushion Mild SPF 50	ZINC OXIDE	Zero to Seven Inc.	1e8720b4-5e8b-dc8b-e063-6394a90aad34	2026-05-27	Warnings	Exact identifier application number: M020
GOONGBE Fresh Sun Stick Mild SPF 50	ZINC OXIDE	Zero to Seven Inc.	1e8727a4-0dc0-19dc-e063-6394a90a82b6	2026-05-27	Warnings	Exact identifier application number: M020
Tallow and Sol SUNSCREEN SPF30	NON-NANO ZINC OXIDE 20%	Guangzhou Shengyanghui Industrial Trading Co., Ltd	52c9dc0a-41f7-3e8a-e063-6394a90a8fca	2026-05-27	Warnings	Exact identifier application number: M020
Tallow and SolSUNSCREEN SPF50	NON-NANO ZINC OXIDE 25%	Guangzhou Shengyanghui Industrial Trading Co., Ltd	52cb56cf-f092-9f86-e063-6394a90ac2d3	2026-05-27	Warnings	Exact identifier application number: M020
SPF 50 Mineral Sunscreen Face and Body	ZINC OXIDE	Toddle Born Wild, Inc.	e97d82fe-cd45-43a5-9c1f-3900025240a1	2026-05-27	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58411-480-60	58411048060	1 TUBE in 1 CARTON (58411-480-60) / 50 mL in 1 TUBE	1 tube	2020-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SHISEIDO ULTIMATE SUN PROTECTOR CREAM	SHISEIDO AMERICAS CORPORATION \| Shiseido America Inc.	2026-01-05	HUMAN OTC DRUG LABEL	3