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 189 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Bum Road Tripper Mineral - Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDESun Bum, LLC3dd7b0af-dc37-1701-e063-6294a90a65c32025-09-02WarningsExact identifier
application number: M020
toty Ilumina CC Creamy Compact 6NTITANIUM DIOXIDEChipican LLC3da732e7-19b0-3195-e063-6394a90a9a0c2025-09-01WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 4ENSULIZOLE ,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3dba1360-f70f-e450-e063-6394a90a8c9f2025-09-01WarningsExact identifier
application number: M020
TOCOBO Cotton Airy Sun StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPICTON CO., Ltd.2f7e7ef4-c3ac-4c26-e063-6394a90a9e422025-09-01WarningsExact identifier
application number: M020
TOCOBO Bio Watery Sun ScreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPICTON CO., Ltd.3a7db6f4-66fd-4473-e063-6394a90a886e2025-09-01WarningsExact identifier
application number: M020
TOCOBO Bio Watery Sun ScreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPICTON CO., Ltd.2f7eb413-ff49-711d-e063-6394a90ad6dc2025-09-01WarningsExact identifier
application number: M020
Ocean Potion Suncare Mineral 30 Essential Scent of Sunshine Zinc Oxide SunscreenZINC OXIDEGNL BRANDS INTERNATIONAL, LLC3db1cf3e-0640-6821-e063-6294a90a70362025-08-31WarningsExact identifier
application number: M020
Purpose Dual Treatment SPF 10OCTINOXATE 7.5%, OCTISALATE 5%, OXYBENZONE 3%Elysium Consumer Healthcare LLC3d7fe711-a671-df30-e063-6394a90afbbf2025-08-29WarningsExact identifier
application number: M020
Good Weather Skin The One Daily Sun Warm Glow SPF 30ZINC OXIDEGood Weather Inc.3d83aaa5-0e4e-928a-e063-6294a90a24da2025-08-29WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 33N DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Le249507c-d536-4c1d-a99d-857ca1e833d82025-08-29WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 32W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lba99edea-bf68-4118-8bb7-ea40322db46a2025-08-29WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 34W DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L3a239897-9850-417f-8c00-e810a52540c12025-08-29WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 36N DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lc495afc3-6486-4652-b743-958f28eccaca2025-08-29WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 35W DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L5440ed13-b07e-4c81-a407-d9ac68eaa4832025-08-29WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 37W DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L9b2c4567-fde7-4b76-9988-b2cba2d3747e2025-08-29WarningsExact identifier
application number: M020
Neutrogena Hydro Boost Hyaluronic Acid Moisturizer Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC3abd12f4-cbe3-4dd7-e063-6394a90a50a22025-08-28WarningsExact identifier
application number: M020
Sun Bum 15 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3d49b054-9f49-17d1-e063-6294a90a757a2025-08-28WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 2ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3d55291c-9d4c-85c3-e063-6394a90af3302025-08-27WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 3ENSULIZOLE ,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3d565612-ade5-bfb3-e063-6294a90a0c652025-08-27WarningsExact identifier
application number: M020
Jack Black Double DutyAVOBENZONE OCTOCRYLENEJack Black L.L.C.36d81d6d-4f9b-692d-e063-6294a90ad5592025-08-27WarningsExact 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