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 70 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MISSHA ALL AROUND ESSENCE SUNSCREEN	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Able C&C Co., Ltd.	48f557b5-a844-8c94-e063-6394a90af220	2026-01-22	Warnings	Exact identifier application number: M020
MISSHA GLOW DEWY HDRATING SUNSCREEN	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Able C&C Co., Ltd.	48f5e9ab-38e0-f12c-e063-6294a90aab8b	2026-01-22	Warnings	Exact identifier application number: M020
MISSHA GLOW WEIGHTLESS PRIMING SUNSCREEN	ZINC OXIDE, HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE	Able C&C Co., Ltd.	48f6361d-d738-62df-e063-6294a90aaac5	2026-01-22	Warnings	Exact identifier application number: M020
SOLBAR SUNSCREEN 35 AVO	SUNSCREEN	Person and Covey	4a5692d5-0835-d18f-e063-6394a90a2929	2026-01-22	Warnings	Exact identifier application number: M020
Sunscreen Lip Balm SPF15	OCTINOXATE, AVOBENZONE, OCTISALATE	Dongguan Taimeng Accessories Co., Ltd.	48f70710-7960-5fa5-e063-6394a90a4ce6	2026-01-22	Warnings	Exact identifier application number: M020
SOLBAR SUNSCREEN 40 ZINC	SUNSCREEN	Person and Covey	48fc01dd-0be4-5c63-e063-6294a90a2362	2026-01-22	Warnings	Exact identifier application number: M020
SOLBAR SUNSCREEN 40 SHIELD	SUNSCREEN	Person and Covey	48fcd463-8ce4-1e78-e063-6394a90a98e7	2026-01-22	Warnings	Exact identifier application number: M020
SOLBAR SUNSCREEN 50 FIFTY	SUNSCREEN	Person and Covey	48fef521-1b24-d0d5-e063-6394a90ac7b1	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 110	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	7456f4bb-d0ec-439d-b807-d00b4c01c111	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 121	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	2dd51960-515f-4502-b261-5e5d5f57e091	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 140	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	5b835716-af13-4e23-bdae-d391864acb6f	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 132	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	fa258570-ee21-423d-bad6-010d14792a86	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 212	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	fa84c1b5-a9b6-408e-b9fd-0dadebaf374e	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 221	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	6b7a016c-c3b1-4f90-80c9-fe47c5291649	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 151	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	5d029d93-7f3d-4624-bcd7-40df9230414e	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 232	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	8f724d68-3c6e-4b95-894e-78b2da220a30	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 241	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	a100b05a-06b7-4c65-9822-3f62ca029f40	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 331	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	c3dd293c-8819-4406-af60-41b632a8c00f	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 342	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	99a92fc5-9a3e-434a-9a5b-3cc47efeea53	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 351	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	e6cd9c7a-29ef-4132-a3e5-575dddb36a9e	2026-01-22	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