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

Shiseido Future Solution LX Total Protective E by

Drug Labeling and Warnings

Shiseido Future Solution LX Total Protective E 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 2.0%	Sunscreen
OCTINOXATE 7.4%	Sunscreen
OCTOCRYLENE 3.0%	Sunscreen
OXYBENZONE 1.5%	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∙BEHENYL ALCOHOL∙BUTYLENE GLYCOL∙ISOHEXADECANE∙SD ALCOHOL 40-B∙SILICA∙CAPRYLIC/CAPRIC TRIGLYCERIDE∙MYRISTYL MYRISTATE∙DIMETHICONE∙POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER∙SORBITOL∙STEARYL ALCOHOL∙PHYTOSTERYL MACADAMIATE∙TOCOPHERYL ACETATE∙PEG/PPG-17/4 DIMETHYL ETHER∙PIPERIDINEPROPIONIC ACID∙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∙BEHENETH-20∙SUCCINOGLYCAN∙TRISODIUM EDTA∙SODIUM CITRATE∙ALCOHOL∙BHT∙SODIUM METAPHOSPHATE∙CITRIC ACID∙TALC∙DEXTRIN PALMITATE∙TOCOPHEROL∙METHYLPARABEN∙ETHYLPARABEN∙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 - 50 mL Jar Carton

SHI SEIDO
GINZA TOKYO

FUTURE SOLUTION LX

Total Protective Cream

SkingenecellEnmei

BROAD SPECTRUM SPF 20
SUNSCREEN

50mL NET WT. 1.7 OZ.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-328
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1017 mg  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3763 mg  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1526 mg  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	763 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
DOCOSANOL (UNII: 9G1OE216XY)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISOHEXADECANE (UNII: 918X1OUF1E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
DIMETHICONE (UNII: 92RU3N3Y1O)
SORBITOL (UNII: 506T60A25R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K)
PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)
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)
BEHENETH-20 (UNII: BJ4GP2IFLN)
EDETATE TRISODIUM (UNII: 420IP921MB)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TALC (UNII: 7SEV7J4R1U)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-328-50	1 in 1 CARTON	08/01/2017
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 final	part352	08/01/2017

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(58411-328) , analysis(58411-328)