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 150 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Srubs SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEITW Pro Brands06c1dc42-5a01-f898-e063-6394a90a1a1a2025-12-05WarningsExact identifier
application number: M020
OUHOE Tinted SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.4540f542-248d-bcf5-e063-6294a90aabca2025-12-05WarningsExact identifier
application number: M020
No 7 Restore and Renew Multi Action Fragrance Free Day Cream SPF 25AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS45c7703b-7ab4-2ef2-e063-6294a90a2b462025-12-05WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Day Cream Sunscreen Broad Spectrum SPF 25AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS4645b051-ef5a-521e-e063-6294a90a24042025-12-05WarningsExact identifier
application number: M020
SPF 50 Mineral Sunscreen bkidsZINC OXIDEKAS Direct LLC dba BabyGanicsf717cd89-194b-42e3-a079-24b2903deb292025-12-05WarningsExact identifier
application number: M020
Sugargirl Set SPF 30 sunscreen shimmer sunscreen mist for the faceHOMOSALATE , OCTOCRYLENE ,OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451b662a-70ed-8ec5-e063-6294a90a005b2025-12-04WarningsExact identifier
application number: M020
Sugargirl SPF 30 sunscreen illuminating stick sunlightHOMOSALATE ,OCTOCRYLENE ,OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451b71a9-2240-853f-e063-6394a90ac8f42025-12-04WarningsExact identifier
application number: M020
Poolside Orange Creme SPF 30 SCENTED gel sunscreenHOMOSALATE,OCTOCRYLENE,OCTISALATE,OCTIONXATE,AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451b7229-67d1-8b0e-e063-6394a90ab71e2025-12-04WarningsExact identifier
application number: M020
Sugargirl SPF 30 sunscreen illuminating stick solarHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451b7229-67d3-8b0e-e063-6394a90ab71e2025-12-04WarningsExact identifier
application number: M020
Poolside Sun Silk Body Cream SUNGLOW 05 FRAGRANCE Sunscreen SPF 30 body creamHOMOSALATE, OCTOCRYENE, OCTISALATE, QCTINOXATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451b86fa-6c1c-a708-e063-6394a90a47a92025-12-04WarningsExact identifier
application number: M020
Poolside Clear Intentions Invisible Face Sunscreen SPF 30HOMOSALATE, OCTOCRYLENE, OCTISALATE,OCTINOXATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451b902d-892d-15f1-e063-6294a90a30242025-12-04WarningsExact identifier
application number: M020
Sugargirl sun gloss SPF15 tinted lip gloss Sunscreen Vanilla IcingHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451ba227-7973-1378-e063-6294a90ae8932025-12-04WarningsExact identifier
application number: M020
Sugargirl sun gloss SPF15 tinted lip gloss Sunscreen Pink IceHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451ba704-6fbd-d5a0-e063-6394a90a2fbc2025-12-04WarningsExact identifier
application number: M020
Sugargirl sun gloss SPF15 tinted lip gloss Sunscreen Tropic TwistHOMOSALATE,OCTOCRYLENE, OCTISALATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451bb62e-b603-7663-e063-6294a90a46db2025-12-04WarningsExact identifier
application number: M020
Prequel Lip Visor SPF 30 ROSEDUSTLIP 30 CLEARThe Center Brands, LLC33d5e1ad-ba7a-25f8-e063-6294a90aa38e2025-12-04WarningsExact identifier
application number: M020
Resting Beach Face SPF30 Anti-Pollution Sunscreen SerumBUTYL METHOXYDIBENZOYLMETHANE, HOMOSALATE, OCTYL SALICYLATE, OCTOCRYLENEEveryday Group Limted54f8aca8-fbbc-498a-aaf8-aee716511dde2025-12-04WarningsExact identifier
application number: M020
Oh My Bod SPF50 Antioxidant Infused Dry Touch SunscreenBUTYL METHOXYDIBENZOYLMETHANE, HOMOSALATE, OCTOCRYLENE, OCTYL SALICYLATEEveryday Group Limted48e70326-ecf7-44c9-a4cc-2044bd6a64152025-12-04WarningsExact identifier
application number: M020
LIGHTSAVE TRIPLESOME SERUM TINTEDZINC OXIDEReve Skincare LLC35f5652f-3e6b-71c9-e063-6294a90a9e862025-12-04WarningsExact identifier
application number: M020
LIGHTSAVE TRIPLESOME SERUM IVORTYZINC OXIDEReve Skincare LLC35f4dd1b-c3d9-8408-e063-6394a90a79142025-12-04WarningsExact identifier
application number: M020
Activated Mineral Sunscreen TintedACTIVATED MINERAL SUNSCREEN TINTEDReve Skincare LLC312a32a7-d253-f10c-e063-6294a90a803a2025-12-04WarningsExact 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