SHISEIDO FUTURE SOLUTION LX UNIVERSAL DEFENSE E- octisalate, octocrylene, and zinc oxide cream

SHISEIDO FUTURE solution LX UNIVERSAL DEFENSE E by

Drug Labeling and Warnings

SHISEIDO FUTURE solution LX UNIVERSAL DEFENSE E by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION, SHISEIDO AMERICAS INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Octisalate 5.0%	Sunscreen
Octocrylene 7.0%	Sunscreen
Zinc Oxide 15.4%	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.

Flammable. Do not use near heat, flame or while smoking.

Directions

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every two 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 ▪ ISODODECANE ▪ CAPRYLYL METHICONE ▪ SD ALCOHOL 40-B ▪ BUTYLENE GLYCOL ▪ GLYCERIN ▪ DIMETHICONE ▪ PEG-60 HYDROGENATED CASTOR OIL ▪ TOCOPHERYL ACETATE ▪ 2-O-ETHYL ASCORBIC ACID ▪ PRUNUS SPECIOSA LEAF EXTRACT ▪ ANGELICA ACUTILOBA ROOT EXTRACT ▪ SCUTELLARIA BAICALENSIS ROOT EXTRACT ▪ RUBUS IDAEUS (RASPBERRY) FRUIT EXTRACT ▪ SODIUM ACETYLATED HYALURONATE ▪ ISODONIS JAPONICUS LEAF/STALK EXTRACT ▪ CAMELLIA SINENSIS LEAF EXTRACT ▪ ROSA ROXBURGHII FRUIT EXTRACT ▪ POLYQUATERNIUM-51 ▪ POLYMETHYL METHACRYLATE ▪ PPG-17 ▪ HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER ▪ ISOSTEARIC ACID ▪ PEG-100 HYDROGENATED CASTOR OIL ▪ C30-45 ALKYL METHICONE ▪ DIMETHYLACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE CROSSPOLYMER ▪ C30-45 OLEFIN ▪ SORBITAN SESQUIISOSTEARATE ▪ HYDROGEN DIMETHICONE ▪ TRIETHOXYCAPRYLYLSILANE ▪ CELLULOSE GUM ▪ SODIUM METAPHOSPHATE ▪ SUCCINOGLYCAN ▪ CITRIC ACID ▪ ALCOHOL ▪ SILICA ▪ BHT ▪ TOCOPHEROL ▪ DISODIUM EDTA ▪ HYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHER ▪ ALUMINA ▪ SODIUM METABISULFITE ▪ SODIUM CITRATE ▪ TALC ▪ PEG-12 DIMETHICONE ▪ DISODIUM PHOSPHATE ▪ BARIUM SULFATE ▪ ERGOTHIONEINE ▪ SODIUM PHOSPHATE ▪ PHENOXYETHANOL ▪ FRAGRANCE ▪ TITANIUM DIOXIDE ▪ MICA ▪ 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 Tube Carton

SHISEIDO
GINZA TOKYO

FUTURE SOLUTION LX
Universal Defense

SkingenecellEnmei

BROAD SPECTRUM
SPF 50+

WATER RESISTANT (40 MINUTES)
SUNSCREEN

50mL NET WT. 1.7 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO FUTURE SOLUTION LX UNIVERSAL DEFENSE E 
octisalate, octocrylene, and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-482
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.523 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3.532 g  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7.723 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISODODECANE (UNII: A8289P68Y2)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)
PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
RASPBERRY (UNII: 4N14V5R27W)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
PPG-17 (UNII: OV0Q322E0U)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
ISOSTEARIC ACID (UNII: X33R8U0062)
C30-45 ALKYL METHICONE (UNII: NFX970DSI2)
C30-45 OLEFIN (UNII: 6DWD51M0O8)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALCOHOL (UNII: 3K9958V90M)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
TALC (UNII: 7SEV7J4R1U)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
BARIUM SULFATE (UNII: 25BB7EKE2E)
ERGOTHIONEINE (UNII: BDZ3DQM98W)
SODIUM PHOSPHATE (UNII: SE337SVY37)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-482-60	1 in 1 CARTON	01/01/2020
1		50 mL in 1 TUBE; 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	01/01/2020

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICAS INC.		782677132	MANUFACTURE(58411-482) , ANALYSIS(58411-482)