SHISEIDO FUTURE SOLUTION LX TOTAL PROTECTIVE S- avobenzone, homosalate, octisalate, and octocrylene cream

SHISEIDO FUTURE solution LX TOTAL PROTECTIVE S by

Drug Labeling and Warnings

SHISEIDO FUTURE solution LX TOTAL PROTECTIVE S by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION, Shiseido America Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
AVOBENZONE 2.3%	Sunscreen
HOMOSALATE 10.0%	Sunscreen
OCTISALATE 4.5%	Sunscreen
OCTOCRYLENE 5.0%	Sunscreen

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

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:

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 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

WATER∙GLYCERIN∙DIPROPYLENE GLYCOL∙SILICA∙BEHENYL ALCOHOL∙BUTYLENE GLYCOL∙ALCOHOL DENAT.∙MYRISTYL MYRISTATE∙DIMETHICONE∙ISODODECANE∙STEARYL ALCOHOL∙PHYTOSTERYL MACADAMIATE∙PEG-6∙PEG-32∙TRIMETHYLSILOXYSILICATE∙HYDROGENATED POLYISOBUTENE∙TOCOPHERYL ACETATE∙PEG/PPG-17/4 DIMETHYL ETHER∙PIPERIDINEPROPIONIC ACID∙XANTHAN GUM∙2-O-ETHYL ASCORBIC ACID∙PRUNUS SPECIOSA LEAF EXTRACT∙SCUTELLARIA BAICALENSIS ROOT EXTRACT∙ANGELICA ACUTILOBA ROOT EXTRACT∙CAMELLIA SINENSIS LEAF EXTRACT∙CHAENOMELES SINENSIS FRUIT EXTRACT∙ISODONIS JAPONICUS LEAF/STALK EXTRACT∙PRUNUS PERSICA (PEACH) LEAF EXTRACT∙ZANTHOXYLUM PIPERITUM PEEL EXTRACT∙HYDROLYZED SILK∙BEHENETH-20∙ALCOHOL∙SUCCINOGLYCAN∙TRISODIUM EDTA∙SODIUM CITRATE∙TOCOPHEROL∙SODIUM METAPHOSPHATE∙BHT∙CITRIC ACID∙SODIUM METABISULFITE∙MICA∙PHENOXYETHANOL∙FRAGRANCE∙IRON OXIDES∙TITANIUM DIOXIDE∙

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 Jar Carton

SHISEIDO
GINZA TOKYO

FUTURE SOLUTION LX

Total Protective Cream

Inspired by Enmei Herb

BROAD SPECTRUM SPF 30
SUNSCREEN

50mL NET WT. 1.8 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO FUTURE SOLUTION LX TOTAL PROTECTIVE S 
avobenzone, homosalate, octisalate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-893
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.18565 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5.155 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.31975 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.5775 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DOCOSANOL (UNII: 9G1OE216XY)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISODODECANE (UNII: A8289P68Y2)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K)
PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)
XANTHAN GUM (UNII: TTV12P4NEE)
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)
PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CHAENOMELES SINENSIS FRUIT (UNII: 6S5Q1Q537Z)
PRUNUS PERSICA LEAF (UNII: VN3501T41P)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
BEHENETH-20 (UNII: BJ4GP2IFLN)
ALCOHOL (UNII: 3K9958V90M)
EDETATE TRISODIUM (UNII: 420IP921MB)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
MICA (UNII: V8A1AW0880)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-893-50	1 in 1 CARTON	06/01/2024
1		50 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	06/01/2024

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Registrant - Shiseido America Inc. (782677132)

Establishment
Name	Address	ID/FEI	Business Operations
Shiseido America Inc.		782677132	ANALYSIS(58411-893) , MANUFACTURE(58411-893)