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

Shiseido Future Solution LX Total Protective by

Drug Labeling and Warnings

Shiseido Future Solution LX Total Protective 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 1.5%	Sunscreen
OCTINOXATE 7.4%	Sunscreen
OCTOCRYLENE 2.0%	Sunscreen
OXYBENZONE 1.0%	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∙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

• 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 - 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.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-327
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1136 mg  in 75 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5606 mg  in 75 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1515 mg  in 75 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	758 mg  in 75 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-327-10	1 in 1 CARTON	08/01/2017
1		75 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/01/2017

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(58411-327) , analysis(58411-327)