FDA.reportPublic FDA data

SHISEIDO FUTURE solution LX UNIVERSAL DEFENSE E

Product NDC
58411-482
11-digit product format
584110482
Labeler code
58411
Product ID
58411-482_47a942d9-4873-7a93-e063-6394a90abf65
Type
HUMAN OTC DRUG
Nonproprietary name
OCTISALATE, 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; OCTOCRYLENE; ZINC OXIDE
Active strength
2.523; 3.532; 7.723 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 FUTURE solution LX UNIVERSAL DEFENSE E
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE2.523 g/50mL
OCTOCRYLENE3.532 g/50mL
ZINC OXIDE7.723 g/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6d2f82d5-b3af-44af-b6b0-de96a4cd95fcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1Product name120201123
85bed648-23ca-4804-98e6-e36aee999cadProduct name120190717
80de93b4-8a94-428d-beb7-d644353ee70bProduct name120180424
eb4f7d5b-1286-40dc-b8bf-ad87ff51c688Product name120170522
db8eb201-78c7-4590-8a71-fac0a539bd8cProduct name120170404
141092be-5eb5-452e-9f69-2d350aa70a87Product name120161208
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-482-60SHISEIDO FUTURE solution LX UNIVERSAL DEFENSE E1 in 1 CARTONCREAM13
58411-482-60SHISEIDO FUTURE solution LX UNIVERSAL DEFENSE E50 mL in 1 TUBECREAM503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58411-482SHISEIDO FUTURE SOLUTION LX UNIVERSAL DEFENSE E (OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICAS CORPORATION]2Current NDC, Legacy NDC, 2 package rows20241228_6d2f82d5-b3af-44af-b6b0-de96a4cd95fc.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 223 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Defense Minerals (Deep)ZINC OXIDEEminence Organic Skin Care2e24391f-4982-efae-e063-6394a90accaa2025-03-01WarningsExact identifier
application number: M020
FRUDIA Blueberry Hydrating Air Fit SunscreenOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEWELCOS CO.,LTD.8b2a1baa-e528-48d6-9cd8-c3cb55e0641b2025-02-28WarningsExact identifier
application number: M020
BRUSH ON BLOCK SPF 50 MINERALZINC OXIDESPF Ventures, LLC2f1b5454-8bf5-b447-e063-6394a90a743a2025-02-27WarningsExact identifier
application number: M020
Clear Defense SPF 45ZINC OXIDE, OCTINOXATEPrivate Label Skin Cared681d92f-3501-4fca-b629-096341f20ab12025-02-27WarningsExact identifier
application number: M020
HA Physical Tint SPF 44ZINC OXIDE, TITANIUM DIOXIDEPrivate Label Skin Carea5e19d77-703e-41e0-9a02-19227dc6c8192025-02-27WarningsExact identifier
application number: M020
Physical Daily Defense Broad Spectrum Sunscreen SPF 40ZINC OXIDEPrivate Label Skin Care18444581-66a4-4eda-a8df-627fa3b4b98a2025-02-26WarningsExact identifier
application number: M020
BRUSH ON BLOCK SPF 50 MINERAL TRANSLUCENT ZINC ONLY REFILLZINC OXIDE/TITANIUM DIOXIDESPF Ventures, LLC2f069114-9ca8-aed4-e063-6394a90a46d82025-02-26WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Cream230 NMelaleuca Inc.2f133abb-cad2-2ac8-e063-6294a90aa4802025-02-26WarningsExact identifier
application number: M020
BRUSH ON BLOCK SPF 50 KIDS MINERALZINC OXIDESPF Ventures, LLC2f17b5fe-44da-964b-e063-6394a90ae6992025-02-26WarningsExact identifier
application number: M020
Sun Defense Minerals (Tan)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2efb73a6-601d-61a4-e063-6294a90af8252025-02-25WarningsExact identifier
application number: M020
Rida Hair Research InstituteAVOBENZONE,OCTISALATE,OCTOCRYLENERida LLCece9dfd8-5f40-49b4-a97e-d4e6ffdb1dca2025-02-25WarningsExact identifier
application number: M020
COOLA Classic Body SPF 70 Peach BlossomAVOBENZONE, OCTISALATE, OCTOCRYLENECOOLA, LLCed217698-f552-677e-e053-2995a90acb0a2025-02-25WarningsExact identifier
application number: M020
COOLA Classic Body SPF 30 Tropical CoconutAVOBENZONE, OCTISALATE, OCTOCRYLENECOOLA, LLCed0f8249-aba8-b67c-e053-2a95a90af7eb2025-02-25WarningsExact identifier
application number: M020
Hydro Essence Broad Spectrum Sunscreen SPF 40ZINC OXIDE, OCTINOXATEPrivate Label Skin Caref176c1b1-f539-417f-98b5-69d99365f2f22025-02-25WarningsExact identifier
application number: M020
Sun Defense Minerals (Tan)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2ee82379-6609-fd8e-e063-6294a90acf6c2025-02-24WarningsExact identifier
application number: M020
Vacation SPF 50 ClassicAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVacation Inc.f2780cb5-063c-10d3-e053-2995a90a85762025-02-24WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC2ee9b3dc-91cd-1af9-e063-6394a90a78e12025-02-24WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC2edc79f8-aac5-15eb-e063-6394a90a97362025-02-23WarningsExact identifier
application number: M020
CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 AVELLANA 270-COCTINOXATE, ZINC OXIDEBEL STAR S Adc25651b-0e30-c325-e053-2995a90a809e2025-02-21WarningsExact identifier
application number: M020
CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 AZUCAR BLANCA 110-COCTINOXATE, ZINC OXIDEBEL STAR S Adc129cd6-a173-d2b3-e053-2a95a90aa04e2025-02-21WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58411-482-60584110482601 TUBE in 1 CARTON (58411-482-60) / 50 mL in 1 TUBE1 tube2020-01-010000-00-00NoNoCurrent