FDA.reportPublic FDA data

SHISEIDO FUTURE LX UNIVERSAL DEFENSE S

Product NDC
58411-902
11-digit product format
584110902
Labeler code
58411
Product ID
58411-902_49732503-4b0d-095d-e063-6294a90a8f4b
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
2025-01-01
Substance
OCTISALATE; OCTOCRYLENE; ZINC OXIDE
Active strength
1.44; 1.44; 9.7 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 LX UNIVERSAL DEFENSE S
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE1.44 g/50mL
OCTOCRYLENE1.44 g/50mL
ZINC OXIDE9.7 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
0a6f8eef-48e9-44f5-9811-629bc0dc07d0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-902-60SHISEIDO FUTURE LX UNIVERSAL DEFENSE S50 mL in 1 TUBECREAM502
58411-902-60SHISEIDO FUTURE LX UNIVERSAL DEFENSE S1 in 1 CARTONCREAM12

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 229 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEBELLE MEDICAL LLC2cdc69d3-2192-7a38-e063-6294a90a257f2025-01-29WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEBoxbar Beauty LLC2d04c5e7-f3aa-873f-e063-6294a90a33d22025-01-29WarningsExact identifier
application number: M020
SEAWEED BATH CO. Super Sheer Face Serum SPF-50ZINC OXIDEThe Seaweed Bath Co.a45b46f9-681f-4a8d-b561-165b995ccf802025-01-28WarningsExact identifier
application number: M020
TiZO Photoceutical AM Replenish Non-TintedZINC OXIDEFallien Cosmeceuticals, LTD2cc62961-dcef-d7db-e063-6394a90a9ebd2025-01-28WarningsExact identifier
application number: M020
Every Sun Day Ultra-Sheer Priming Sunscreen StickAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEHave & Be Co., Ltd.2b53aa68-9c05-1682-e063-6294a90a968c2025-01-28WarningsExact identifier
application number: M020
TiZO Photoceutical AM Replenish - TintedZINC OXIDEFallien Cosmeceuticals, LTD2cc73c4f-30ea-0a51-e063-6394a90ac9a42025-01-28WarningsExact identifier
application number: M020
TiZO Photoceutical AM Replenish - TintedZINC OXIDEFallien Cosmeceuticals, LTD2cc84aba-006b-a78e-e063-6294a90ae0402025-01-28WarningsExact identifier
application number: M020
TiZO Mineral Sun Defense SPF 50TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.2cc8f7ef-eda3-fe71-e063-6394a90a6a9a2025-01-28WarningsExact identifier
application number: M020
Baby Diaper Rash CreamZINC OXIDEdoTERRA International, LLC641465a1-0daf-1bb9-e053-2a91aa0ab25d2025-01-28WarningsExact identifier
application number: M020
HydroPeptide S.P.F. Sun Protection FriendsTITANIUM DIOXIDE, ZINC OXIDEHydroPeptide LLCf3669a1e-8b75-4e94-a3f0-71dcbc3fa9142025-01-28WarningsExact identifier
application number: M020
doTERRA sun Face Daily MoisturizerZINC OXIDEdoTERRA International, LLCf3836517-e3ec-5e9e-e053-2a95a90a7af12025-01-28WarningsExact identifier
application number: M020
doTERRA sunZINC OXIDEdoTERRA International, LLCda5c48d6-1859-983d-e053-2a95a90a4c3e2025-01-28WarningsExact identifier
application number: M020
doTERRA sunZINC OXIDEdoTERRA International, LLCdd2fa6a2-2ba8-4333-e053-2a95a90a97902025-01-28WarningsExact identifier
application number: M020
Tri-water sheer mineral sunscreen cushion SPF30ZINC OXIDEEden Brands Inc.2cd22172-78cb-32f3-e063-6394a90a395d2025-01-28WarningsExact identifier
application number: M020
SOS Face Guard Broad Spectrum Sunscreen SPF 30ZINC OXIDETower 286687006a-bd79-4e1c-a546-0f0b51b299482025-01-28WarningsExact identifier
application number: M020
LBEL CONCENTRE GLOBAL ANTI AGING SERUM CONCEALER SPF 15 EYES FACE ALMENDRA 230OCTINOXATE, ZINC OXIDEBEL STAR S.A.2cb1a767-3228-71ea-e063-6294a90ac89e2025-01-27WarningsExact identifier
application number: M020
Meijer SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMeijer26f7566e-5a89-21cf-e063-6294a90ac8862025-01-27WarningsExact identifier
application number: M020
TiZO Photoceutical AM Replenish Non-TintedZINC OXIDEFallien Cosmeceuticals, LTD2cb77125-ff77-2060-e063-6294a90ab69f2025-01-27WarningsExact identifier
application number: M020
GLOW RECIPE WATERMELON GLOW DEW SHIELD HYDRATING FLUID SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEAramara Beauty LLC dba Glow Recipe2cb90666-6517-a02c-e063-6294a90ab0622025-01-27WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEZ&Z Skin Essentials2cdc48f3-474f-9c06-e063-6294a90afea12025-01-27WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58411-902-60584110902601 TUBE in 1 CARTON (58411-902-60) / 50 mL in 1 TUBE1 tube2025-01-01NoNoCurrent