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 68 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Centellian24 Madeca Derma Shield Vital Airy Sun StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE7054144e11009-ffcb-dd59-e063-6294a90add222026-01-27WarningsExact identifier
application number: M020
Sunscreen SPF50NON NANO ZINC OXIDESBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESIc5d52f13-a649-9579-e053-2a95a90a062c2026-01-27WarningsExact identifier
application number: M020
ONSART Mineral Sunscreen SPF 50ZINC OXIDE 24%Guangzhou Huixue Biotechnology Co., Ltd.495e3266-a59f-42f7-e063-6394a90adfa32026-01-27WarningsExact identifier
application number: M020
Poolside Sun Daze Body Illuminator SPF 30 Shimmer SunscreenHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC54868d6f-ae4c-476d-8c77-c4a72b13d2ea2026-01-27WarningsExact identifier
application number: M020
Sugargirl Set SPF 30 Sunscreen Shimmer Sunscreen Mist For the FaceHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLCdd036e0c-0c27-42b3-9d2c-33839a8631f92026-01-27WarningsExact identifier
application number: M020
Sugargirl Sun Gloss SPF 15 Tinted Lip Gloss Sunscreen Pink IceHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLCea23616f-1d59-4e32-88bb-d035af7277282026-01-27WarningsExact identifier
application number: M020
Sugargirl Sun Gloss SPF 15 Tinted Lip Gloss Sunscreen Tropic TwistHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC21b6239b-26d0-4b6b-8aee-fe1f20d8aaea2026-01-27WarningsExact identifier
application number: M020
Sugargirl Sun Gloss SPF 15 Tinted Lip Gloss Sunscreen Vanilla IcingHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC483b6873-fe58-4a38-bf82-df116617c5f02026-01-27WarningsExact identifier
application number: M020
Zinc Oxide 20%SUNSCREEN SPF 50 MINERALS&C Hampton Sun4960930e-a1bf-d850-e063-6294a90a40842026-01-27WarningsExact identifier
application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen AmalfiCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN AMALFILE COSMETICS INC4963658b-59bb-b313-e063-6394a90a0a512026-01-27WarningsExact identifier
application number: M020
Golden Glow SHIMMER MISTAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENAKED SUNDAYS PTY LTD4963e513-d1fc-4b0e-e063-6394a90a7ddf2026-01-27WarningsExact identifier
application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen RioCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN RIOLE COSMETICS INC49644002-153f-c254-e063-6394a90a46eb2026-01-27WarningsExact identifier
application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen CaboCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN CABOLE COSMETICS INC49643a56-3627-67f8-e063-6294a90a2d7b2026-01-27WarningsExact identifier
application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen CaymansCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN CAYMANSLE COSMETICS INC49644002-153e-c254-e063-6394a90a46eb2026-01-27WarningsExact identifier
application number: M020
Hydrating Glow Mist with Pentavitin SPF 50 Broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENAKED SUNDAYS PTY LTD496ba4c4-6577-88ff-e063-6294a90a09952026-01-27WarningsExact identifier
application number: M020
Vacation Lip BalmAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation INC.b442530f-cae3-418b-9675-c188796538262026-01-27WarningsExact identifier
application number: M020
EltaMD UV Clear Blemish-Prone and Oil BalancingOCTINOXATE AND ZINC OXIDE SUNSCREENCP Skin Health Group, Inc6337b9e3-2524-4292-8fc8-1f6aad6cfe052026-01-27WarningsExact identifier
application number: M020
SPF Ginger Sunscreen SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENESPF GINGER LLCf303ad78-5fa3-40d1-9b1c-53ae1ca73aed2026-01-26WarningsExact identifier
application number: M020
ALOE UP COCO-MANGO SPF-50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC8506049f-cb43-4d1d-885b-c6d3a99bbba32026-01-26WarningsExact identifier
application number: M020
ALOE UP COCO-MANGO SPF-50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC144178e7-2df9-49c3-9667-43986cee89c42026-01-26WarningsExact 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