SHISEIDO FUTURE SOLUTION LX TOTAL PROTECTIVE- avobenzone, octinoxate, octocrylene, and oxybenzone emulsion 
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 TOTAL PROTECTIVE

Drug Facts

Active ingredientsPurpose
AVOBENZONE 1.5%Sunscreen
OCTINOXATE 7.4%Sunscreen
OCTOCRYLENE 2.0%Sunscreen
OXYBENZONE 1.0%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.

Directions

For sunscreen use:

Inactive Ingredients

WATER∙DIPROPYLENE GLYCOL∙SD ALCOHOL 40-B∙GLYCERIN∙HYDROGENATED POLYDECENE∙XYLITOL∙ISODODECANE∙DIMETHICONE∙PEG-5 GLYCERYL STEARATE∙ISOSTEARIC ACID∙SILICA∙PHENYL TRIMETHICONE∙TRIETHANOLAMINE∙XANTHAN GUM∙TOCOPHERYL ACETATE∙PEG/PPG-17/4 DIMETHYL ETHER∙PIPERIDINEPROPIONIC ACID∙PHYTOSTERYL MACADAMIATE∙2-O-ETHYL ASCORBIC ACID∙PRUNUS SPECIOSA LEAF EXTRACT∙ANGELICA ACUTILOBA ROOT EXTRACT∙ISODONIS JAPONICUS LEAF/STALK EXTRACT∙CAMELLIA SINENSIS LEAF EXTRACT∙ZANTHOXYLUM PIPERITUM PEEL EXTRACT∙PPG-17∙GLYCERYL STEARATE SE∙BEHENYL ALCOHOL∙BEHENIC ACID∙STEARIC ACID∙BATYL ALCOHOL∙PEG-30 PHYTOSTEROL∙BUTYLENE GLYCOL∙CARBOMER∙DISODIUM EDTA∙ALCOHOL∙BHT∙CELLULOSE GUM∙SODIUM METAPHOSPHATE∙TALC∙DEXTRIN PALMITATE∙TOCOPHEROL∙ETHYLPARABEN∙METHYLPARABEN∙FRAGRANCE∙IRON OXIDES∙

Other information

Questions or comments?

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PRINCIPAL DISPLAY PANEL - 75 mL Bottle Carton

SHI SEIDO
GINZA TOKYO

FUTURE SOLUTION LX

Total Protective Emulsion

SkingenecellEnmei

BROAD SPECTRUM SPF 20
SUNSCREEN

75mL 2.5 FL. OZ.

PRINCIPAL DISPLAY PANEL - 75 mL Bottle Carton
SHISEIDO FUTURE SOLUTION LX TOTAL PROTECTIVE 
avobenzone, octinoxate, octocrylene, and oxybenzone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-327
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1136 mg  in 75 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5606 mg  in 75 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1515 mg  in 75 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE758 mg  in 75 mL
Inactive Ingredients
Ingredient NameStrength
PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)  
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)  
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)  
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)  
PPG-17 (UNII: OV0Q322E0U)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
DOCOSANOL (UNII: 9G1OE216XY)  
BEHENIC ACID (UNII: H390488X0A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BATILOL (UNII: 39YR661C4U)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALCOHOL (UNII: 3K9958V90M)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
TALC (UNII: 7SEV7J4R1U)  
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
ETHYLPARABEN (UNII: 14255EXE39)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
WATER (UNII: 059QF0KO0R)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
XYLITOL (UNII: VCQ006KQ1E)  
ISODODECANE (UNII: A8289P68Y2)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
TROLAMINE (UNII: 9O3K93S3TK)  
XANTHAN GUM (UNII: TTV12P4NEE)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-327-101 in 1 CARTON08/01/2017
175 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/01/2017
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICA INC.782677132manufacture(58411-327) , analysis(58411-327)

Revised: 12/2018
Document Id: 7cf28e2f-2a30-27bf-e053-2991aa0a27b2
Set id: 6de17911-4bce-46c9-906b-07d899a36ceb
Version: 2
Effective Time: 20181213
 
SHISEIDO AMERICAS CORPORATION