FDA.reportPublic FDA data

SHISEIDO ULTIMATE SUN PROTECTOR

Product NDC
58411-481
11-digit product format
584110481
Labeler code
58411
Product ID
58411-481_e6522904-8d36-4733-bc3e-7eae181fc7a8
Type
HUMAN OTC DRUG
Nonproprietary name
octisalate, homosalate, octocrylene, and avobenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
SHISEIDO AMERICAS CORPORATION
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-01
Substance
OCTISALATE; HOMOSALATE; OCTOCRYLENE; AVOBENZONE
Active strength
50; 100; 50; 23 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE50 mg/mL
HOMOSALATE100 mg/mL
OCTOCRYLENE50 mg/mL
AVOBENZONE23 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
V06SV4M95SInternal UNII lookup
5A68WGF6WMInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7a98171f-bf21-40d4-bc78-883aa0b0c438Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-481-10SHISEIDO ULTIMATE SUN PROTECTOR1 in 1 CARTONLOTION15
58411-481-10SHISEIDO ULTIMATE SUN PROTECTOR150 mL in 1 BOTTLELOTION1505
58411-481-11SHISEIDO ULTIMATE SUN PROTECTOR50 mL in 1 BOTTLELOTION505
58411-481-11SHISEIDO ULTIMATE SUN PROTECTOR1 in 1 CARTONLOTION15
58411-481-12SHISEIDO ULTIMATE SUN PROTECTOR1 in 1 CARTONLOTION15
58411-481-12SHISEIDO ULTIMATE SUN PROTECTOR300 mL in 1 BOTTLELOTION3005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58411-481SHISEIDO ULTIMATE SUN PROTECTOR (OCTISALATE, HOMOSALATE, OCTOCRYLENE, AND AVOBENZONE) LOTION [SHISEIDO AMERICAS CORPORATION]5Current NDC, Legacy NDC, 6 package rows20250322_7a98171f-bf21-40d4-bc78-883aa0b0c438.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 152 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BINDA Face and Body Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED386f5013-430c-e07f-e063-6394a90a32a82025-12-04WarningsExact identifier
application number: M020
Poolside Not Your Babys Oil. SPF 30 sunscreen body oil.HOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452bcb25-848c-e8a7-e063-6394a90ace0f2025-12-04WarningsExact identifier
application number: M020
Sugargirl Glowy face screen sunbeam shimmer sunscreen for the face SPF 30HOMOSALATE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452bd1d2-6a9f-f5e8-e063-6394a90ac9e32025-12-04WarningsExact identifier
application number: M020
Poolside Butter SCREEN SPF 30 sunscreen ButterHOMOSALATE , OCTOCRYLENE , OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452bd24d-8654-e6c0-e063-6394a90a0aea2025-12-04WarningsExact identifier
application number: M020
Poolside Glow Butter Screen SPF 30 Shimmer sunscreen ButterHOMOSALATE , OCTOCRYLENE, OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452bd69e-02c7-fcbd-e063-6394a90ae59b2025-12-04WarningsExact identifier
application number: M020
Softlips CherryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Companybececc42-1321-430a-80ef-438060fdcc862025-12-04WarningsExact identifier
application number: M020
ATTITUDE Sunly Lip Balm SPF 15 WatermelonZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE450d038b-3f99-add8-e063-6294a90aee9a2025-12-03WarningsExact identifier
application number: M020
Natrience Broad Spectrum SPF 30SKIN SHIELDSisel International, LLC1989370f-68a6-6f22-e063-6394a90aacaf2025-12-03Boxed warning, WarningsExact identifier
application number: M020
ATTITUDE Super leaves Lip Balm SPF 15 CoconutZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE450d8fd0-20ad-1920-e063-6394a90a72712025-12-03WarningsExact identifier
application number: M020
ATTITUDE Super leaves Lip Balm SPF 15 ExoticZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE450db2bb-1788-efc2-e063-6294a90a13c02025-12-03WarningsExact identifier
application number: M020
ATTITUDE Super leaves Lip Balm SPF 15 WatermelonZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE450dcc02-8bcb-6c07-e063-6394a90a5df42025-12-03WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral Sunscreen Face Stick SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44acf513-ffe6-888c-e063-6394a90a9c5c2025-12-03WarningsExact identifier
application number: M020
ATTITUDE Sunly Baby Mineral Sunscreen Face Stick SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE450e52a9-5a6b-112f-e063-6394a90af7ca2025-12-03WarningsExact identifier
application number: M020
ATTITUDE Sunly Kids Mineral Sunscreen Face Stick SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE450e6eb7-f49e-296e-e063-6294a90a05a42025-12-03WarningsExact identifier
application number: M020
Attitude - Leaves Bar - Lip Balm - SPF 15 - MangoZINC OXIDE9055-7588 Qubec Inc. DBA Attitude359a7ebf-46a6-4e99-b43c-f585e9bc08d92025-12-03WarningsExact identifier
application number: M020
ATTITUDE Sunly Lip balm Unscented SPF 15ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d95a2b7-288d-7b29-e063-6294a90ae46b2025-12-03WarningsExact identifier
application number: M020
Attitude - Lip Balm - SPF 15 - CoconutZINC OXIDEAttitude DBA 9055-7588 Qubec Inc.068af2ec-a666-45bf-b0e0-89d1b93dedf12025-12-03WarningsExact identifier
application number: M020
Cancer Council Invisible Fluid SPF50 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVitality US Co.1629b02b-e9f3-0593-e063-6294a90a9aa52025-12-03WarningsExact identifier
application number: M020
PRO-TECT SPORTS SUNSCREENMERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONEBio-Medical & Pharmaceutical Manufacturing Corporation16994959-cade-06de-e054-00144ff88e882025-12-03WarningsExact identifier
application number: M020
PRO-TECT SPORTS SUNSCREENMERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONEBio-Medical & Pharmaceutical Manufacturing Corporation66bb06fb-33d2-4b57-a65f-66bcd187c6272025-12-03WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58411-481-10584110481101 BOTTLE in 1 CARTON (58411-481-10) / 150 mL in 1 BOTTLE1 bottle2020-01-010000-00-00NoNoCurrent
58411-481-11584110481111 BOTTLE in 1 CARTON (58411-481-11) / 50 mL in 1 BOTTLE1 bottle2020-01-010000-00-00NoNoCurrent
58411-481-12584110481121 BOTTLE in 1 CARTON (58411-481-12) / 300 mL in 1 BOTTLE1 bottle2020-01-01NoNoCurrent