SHISEIDO FUTURE SOLUTION LX TOTAL PROTECTIVE- avobenzone, octinoxate, and octocrylene 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., Davlyn Industries Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:	Purpose
AVOBENZONE 2.5%	Sunscreen
OCTINOXATE 7.4%	Sunscreen
OCTOCRYLENE 2.0%	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, DIMETHICONE, ISODODECANE, XYLITOL, SILICA, TRIETHYLHEXANOIN, GLYCERIN, HYDROGENATED POLYDECENE, PEG-5 GLYCERYL STEARATE, ISOSTEARIC ACID, DIPHENYLSILOXY PHENYL TRIMETHICONE, XANTHAN GUM, ERYTHRITOL, SODIUM HYALURONATE, TOCOPHERYL ACETATE, PIPERIDINEPROPIONIC ACID, SACCHAROMYCES FERMENT LYSATE FILTRATE, SODIUM ACETYLATED HYALURONATE, ONONIS SPINOSA ROOT EXTRACT, AVERRHOA CARAMBOLA LEAF EXTRACT, HIBISCUS ESCULENTUS FRUIT EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, ZANTHOXYLUM PIPERITUM PEEL EXTRACT, PPG-17, TRIETHANOLAMINE, GLYCERYL STEARATE SE, BEHENIC ACID, STEARIC ACID, BEHENYL ALCOHOL, BATYL ALCOHOL, PEG-30 SOY STEROL, DISODIUM EDTA, BUTYLENE GLYCOL, ALCOHOL, CELLULOSE GUM, SODIUM METAPHOSPHATE, BHT, SODIUM METABISULFITE, TOCOPHEROL, PHENOXYETHANOL, 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

SHISEIDO

FUTURE SOLUTION LX

Total Protective Emulsion

BROAD SPECTRUM
SPF 18

SUNSCREEN

75mL 2.5 FL. OZ.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-141
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1896 mg  in 75.83 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5611 mg  in 75.83 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1517 mg  in 75.83 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISODODECANE (UNII: A8289P68Y2)
XYLITOL (UNII: VCQ006KQ1E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)
ISOSTEARIC ACID (UNII: X33R8U0062)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
XANTHAN GUM (UNII: TTV12P4NEE)
ERYTHRITOL (UNII: RA96B954X6)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ONONIS SPINOSA ROOT (UNII: FD2FMC53M1)
AVERRHOA CARAMBOLA LEAF (UNII: HB7UP0QK1T)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
PPG-17 (UNII: OV0Q322E0U)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
BEHENIC ACID (UNII: H390488X0A)
STEARIC ACID (UNII: 4ELV7Z65AP)
DOCOSANOL (UNII: 9G1OE216XY)
BATILOL (UNII: 39YR661C4U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-141-10	1 in 1 CARTON	02/01/2014
1		75.83 g 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 NOT FINAL	part352	02/01/2014

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	MANUFACTURE(58411-141) , ANALYSIS(58411-141)