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 38 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RE SCREEN BROAD SPECTRUM SPF 30 SUNSCREENZINC OXIDEZouck LLC507560fe-c7ad-329a-e063-6394a90a039a2026-04-27WarningsExact identifier
application number: M020
SoloVeganHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEYES SALES INC.435748e6-c39a-efee-e063-6294a90ad0e52026-04-27WarningsExact identifier
application number: M020
SCREEN SCREEN BROAD SPECTRUM SPF 30 SUNSCREENZINC OXIDEZouck LLC50764f40-7881-81a3-e063-6294a90ad1cf2026-04-27WarningsExact identifier
application number: M020
Obagi Skintrinsiq Antioxidant ProtocolAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEObagi Cosmeceuticals LLC495bc176-b292-448f-a5a6-00de2e475e542026-04-27WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf45bd7bd-a802-33e4-e053-2a95a90a61a72026-04-23WarningsExact identifier
application number: M020
TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMERTRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMERPML NYC, LLC1c2e9b0d-ba0e-1767-e063-6394a90a756c2026-04-23WarningsExact identifier
application number: M020
Skincare LdeL Retinol Day Broad Spectrum SPF 20AVOBENZONE, HOMOSALATE, OXYBENZONE, AND OCTINOXATEBeauty Solutions, Ltd.76e2ed34-c643-402b-9c9d-04eac789d3c22026-04-22WarningsExact identifier
application number: M020
Johnsons Baby Mineral Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC4fe04c4b-2751-0561-e063-6394a90af7682026-04-22WarningsExact identifier
application number: M020
Johnsons Baby Mineral Sunscreen Stick SPF 50ZINC OXIDEKenvue Brands LLC4fe1d3c6-7748-d966-e063-6394a90a97ff2026-04-22WarningsExact identifier
application number: M020
OVERLAPS ECTOIN MOIST SUNAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEOverlaps Corp.4c3ed60b-e515-8ff0-e063-6294a90a86df2026-04-22WarningsExact identifier
application number: M020
Lazy Face SPF 30 FacescreenTITANIUM DIOXIDE, ZINC OXIDESunny Day Creations500ee303-7302-68d5-e063-6394a90ac6d42026-04-22WarningsExact identifier
application number: M020
Lazy Face SPF 30 FacestickZINC OXIDESunny Day Creations50101b55-793e-dbe4-e063-6394a90a61992026-04-22WarningsExact identifier
application number: M020
Broad Spectrum Sunscreen SPF 30OCTOCRYLENE 10% HOMOSALATE 10% OCTISALATE 5 % AVOBENZONE 3%S&C Hampton Sun LLCe6103de6-1d80-46fd-b9d4-893f60941def2026-04-22WarningsExact identifier
application number: M020
PhotoAge GuardAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEMACROMOTION, INC.50164bd8-469d-9ec1-e063-6294a90a543d2026-04-22WarningsExact identifier
application number: M020
THANK YOU FARMER Sun Project Silky Calming Sun StickAVOBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENETHANK YOU FARMER CO., LTD49947114-5137-dc45-e063-6394a90ad9d02026-04-22WarningsExact identifier
application number: M020
Sky and Sol Intense Healing Lip JellyNON-NANO ZINC OXIDEDelta Ecommerce LLC2ddaa215-7433-c8fa-e063-6394a90a43162026-04-22WarningsExact identifier
application number: M020
Broad Spectrum SPF45ZINC OXIDE, OCTINOXATEDrmtlgy, LLC0445ee5f-45a8-4fd5-ae4d-62f66e6f0be82026-04-21WarningsExact identifier
application number: M020
BLDG Active Skin Repair Face and Body Performance SunscreenZINC OXIDEInnovacyn, Inc.70cb98cf-739b-4d46-b45a-535ff0a4531c2026-04-21WarningsExact identifier
application number: M020
Freaks of Nature Mineral SunscreenZINC OXIDE MINERAL SUNSCREENEmpack Spraytech Inc.4ffdb1c6-b2c6-628f-e063-6394a90a27692026-04-21WarningsExact identifier
application number: M020
THANK YOU FARMER Sun Project Water Sun CreamAVOBENZONE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENETHANK YOU FARMER CO., LTD5004126b-0a9c-21fb-e063-6294a90a52372026-04-21WarningsExact 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