SHISEIDO FUTURE SOLUTION LX UNIVERSAL DEFENSE E- octisalate, octocrylene, and zinc oxide cream 
SHISEIDO AMERICAS CORPORATION

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SHISEIDO FUTURE SOLUTION LX UNIVERSAL DEFENSE E

Drug Facts

Active ingredientsPurpose
Octisalate 5.0%Sunscreen
Octocrylene 7.0%Sunscreen
Zinc Oxide 15.4%Sunscreen

Uses

Warnings

For external use only

Do not use on damaged or broken skin

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

Stop use and ask a doctor if rash occurs.

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

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

Directions

For sunscreen use:

Inactive Ingredients

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

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

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

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
SHISEIDO FUTURE SOLUTION LX UNIVERSAL DEFENSE E 
octisalate, octocrylene, and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-482
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.523 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3.532 g  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.723 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISODODECANE (UNII: A8289P68Y2)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)  
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
RASPBERRY (UNII: 4N14V5R27W)  
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
PPG-17 (UNII: OV0Q322E0U)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
C30-45 ALKYL METHICONE (UNII: NFX970DSI2)  
C30-45 OLEFIN (UNII: 6DWD51M0O8)  
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ALCOHOL (UNII: 3K9958V90M)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
TALC (UNII: 7SEV7J4R1U)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-482-601 in 1 CARTON01/01/2020
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/01/2020
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICAS INC.782677132MANUFACTURE(58411-482) , ANALYSIS(58411-482)

Revised: 10/2019
Document Id: 33562033-6702-42ce-8b3a-6a3c3b2e1df0
Set id: 6d2f82d5-b3af-44af-b6b0-de96a4cd95fc
Version: 1
Effective Time: 20191017
 
SHISEIDO AMERICAS CORPORATION