FDA.reportPublic FDA data

SHISEIDO FUTURE solution LX UNIVERSAL DEFENSE E

Manufacturer
SHISEIDO AMERICAS CORPORATION | Shiseido America Inc.
Effective date
2026-01-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:31:19

Label at a glance#

ProductSHISEIDO FUTURE solution LX UNIVERSAL DEFENSE E
Active ingredientOCTISALATE, OCTOCRYLENE, ZINC OXIDE
Label structure9 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

For sunscreen use: apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every two hours Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: l...

Storage and handling

Protect this product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Octisalate 5.0%Sunscreen
Octocrylene7.0% Sunscreen
Zinc Oxide 15.4%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this productkeep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctorif rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If product is swallowed, get medical help or contact a Poison Control Center right away.

SPL UNCLASSIFIED SECTION

Flammable.Do not use near heat, flame or while smoking.

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every two hours
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

WATER ▪ ISODODECANE ▪ CAPRYLYL METHICONE ▪ SD ALCOHOL 40-B ▪ BUTYLENE GLYCOL ▪ GLYCERIN ▪ DIMETHICONE ▪ PEG-60 HYDROGENATED CASTOR OIL ▪ TOCOPHERYL ACETATE ▪ 2-O-ETHYL ASCORBIC ACID ▪ PRUNUS SPECIOSA LEAF EXTRACT ▪ ANGELICA ACUTILOBA ROOT EXTRACT ▪ SCUTELLARIA BAICALENSIS ROOT EXTRACT ▪ RUBUS IDAEUS (RASPBERRY) FRUIT EXTRACT ▪ SODIUM ACETYLATED HYALURONATE ▪ ISODONIS JAPONICUS LEAF/STALK EXTRACT ▪ CAMELLIA SINENSIS LEAF EXTRACT ▪ ROSA ROXBURGHII FRUIT EXTRACT ▪ POLYQUATERNIUM-51 ▪ POLYMETHYL METHACRYLATE ▪ PPG-17 ▪ HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER ▪ ISOSTEARIC ACID ▪ PEG-100 HYDROGENATED CASTOR OIL ▪ C30-45 ALKYL METHICONE ▪ DIMETHYLACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE CROSSPOLYMER ▪ C30-45 OLEFIN ▪ SORBITAN SESQUIISOSTEARATE ▪ HYDROGEN DIMETHICONE ▪ TRIETHOXYCAPRYLYLSILANE ▪ CELLULOSE GUM ▪ SODIUM METAPHOSPHATE ▪ SUCCINOGLYCAN ▪ CITRIC ACID ▪ ALCOHOL ▪ SILICA ▪ BHT ▪ TOCOPHEROL ▪ DISODIUM EDTA ▪ HYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHER ▪ ALUMINA ▪ SODIUM METABISULFITE ▪ SODIUM CITRATE ▪ TALC ▪ PEG-12 DIMETHICONE ▪ DISODIUM PHOSPHATE ▪ BARIUM SULFATE ▪ ERGOTHIONEINE ▪ SODIUM PHOSPHATE ▪ PHENOXYETHANOL ▪ FRAGRANCE ▪ TITANIUM DIOXIDE ▪ MICA ▪ IRON OXIDES ▪

Other information

STORAGE AND HANDLING SECTION

Protect this product in this container from excessive heat and direct sun.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO
GINZA TOKYO

FUTURE SOLUTION LX
Universal Defense

SkingenecellEnmei

BROAD SPECTRUM
SPF 50+

WATER RESISTANT (40 MINUTES)
SUNSCREEN

50mL NET WT. 1.7 OZ.

Principal Display Panel - 50 mL Tube Carton
Principal Display Panel - 50 mL Tube Carton

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 54 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58411-48258411-482-60

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 52 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISODODECANEA8289P68Y2IACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE92RU3N3Y1OIACT
PEG-60 HYDROGENATED CASTOR OIL02NG325BQGIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
2-O-ETHYL ASCORBIC ACID801M14RK9KIACT
PRUNUS SPECIOSA LEAFQ71D900FVUIACT
ANGELICA ACUTILOBA ROOT3W51R3EK30IACT
SCUTELLARIA BAICALENSIS ROOT7J95K7ID2SIACT
RASPBERRY4N14V5R27WIACT
SODIUM ACETYLATED HYALURONATEWN66R7GL93IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ROSA ROXBURGHII FRUITCVT1AA87FFIACT
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)EL9825H96JIACT
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
PPG-17OV0Q322E0UIACT
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMERWB5K9Y35Y9IACT
ISOSTEARIC ACIDX33R8U0062IACT
C30-45 ALKYL METHICONENFX970DSI2IACT
C30-45 OLEFIN6DWD51M0O8IACT
SORBITAN SESQUIISOSTEARATEVU97D01BF9IACT
HYDROGEN DIMETHICONE (13 CST)4QGR4P2YOIIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
SODIUM POLYMETAPHOSPHATEP1BM4ZH95LIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ALCOHOL3K9958V90MIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
EDETATE DISODIUM7FLD91C86KIACT
ALUMINUM OXIDELMI26O6933IACT
SODIUM METABISULFITE4VON5FNS3CIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
TALC7SEV7J4R1UIACT
PEG-12 DIMETHICONE (300 CST)ZEL54N6W95IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHISEIDO FUTURE solution LX UNIVERSAL DEFENSE EOCTISALATE, OCTOCRYLENE, AND ZINC OXIDESHISEIDO AMERICAS CORPORATION6d2f82d5-b3af-44af-b6b0-de96a4cd95fc2026-01-05WarningsExact identifier
ndc (package): 58411-482-60
ndc (product): 58411-482
ndc11 (package): 58411048260
spl id: 47a942d9-4873-7a93-e063-6394a90abf65
spl set id: 6d2f82d5-b3af-44af-b6b0-de96a4cd95fc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.