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

SHISEIDO FUTURE LX UNIVERSAL DEFENSE S by

Drug Labeling and Warnings

SHISEIDO FUTURE LX UNIVERSAL DEFENSE 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
OCTISALATE 2.5%	Sunscreen
OCTOCRYLENE 2.5%	Sunscreen
ZINC OXIDE 16.9%	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 useon damaged or broken skin

When using this productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctorif 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･DIISOPROPYL SEBACATE･ISOPROPYL MYRISTATE･ALCOHOL DENAT.･ALCOHOL･BUTYLENE GLYCOL･GLYCERIN･PPG-3 DIPIVALATE･CAPRYLYL METHICONE･DEXTRIN PALMITATE/ETHYLHEXANOATE･POLYHYDROXYSTEARIC ACID･ACRYLAMIDES/DMAPA ACRYLATES/METHOXY PEG METHACRYLATE COPOLYMER･TOCOPHERYL ACETATE･2-O-ETHYL ASCORBIC ACID･PRUNUS SPECIOSA LEAF EXTRACT･GINKGO BILOBA LEAF EXTRACT･SCUTELLARIA BAICALENSIS ROOT EXTRACT･SODIUM ACETYLATED HYALURONATE･CAMELLIA SINENSIS LEAF EXTRACT･CHAENOMELES SINENSIS FRUIT EXTRACT･ISODONIS JAPONICUS LEAF/STALK EXTRACT･ECTOIN･CAMELLIA JAPONICA SEED EXTRACT･PRUNUS PERSICA (PEACH) LEAF EXTRACT･HYDROLYZED SILK･ROSA ROXBURGHII FRUIT EXTRACT･POLYQUATERNIUM-51･PEG-100 HYDROGENATED CASTOR OIL･HYDROGEN DIMETHICONE･SILICA･DIMETHYLACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE CROSSPOLYMER･HYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHER･SUCCINOGLYCAN･HYDROGENATED PALM OIL･ELAEIS GUINEENSIS (PALM) KERNEL OIL･TOCOPHEROL･BHT･ELAEIS GUINEENSIS (PALM) OIL･SODIUM METABISULFITE･PEG-12 DIMETHICONE･DISODIUM PHOSPHATE･MICA･ERGOTHIONEINE･SODIUM PHOSPHATE･CITRIC ACID･TIN OXIDE･CHLORPHENESIN･PHENOXYETHANOL･FRAGRANCE･TITANIUM DIOXIDE･RED 33･YELLOW 6･YELLOW 5･

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

SPF 50

BROAD SPECTRUM SPF 50

WATER RESISTANT
(40 MINUTES)

SUNSCREEN

Inspired by Enmei Herb

50mL NET WT. 2 OZ.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-902
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.44 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.44 g  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	9.7 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)
PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)
GINKGO (UNII: 19FUJ2C58T)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CHAENOMELES SINENSIS FRUIT (UNII: 6S5Q1Q537Z)
CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)
PRUNUS PERSICA LEAF (UNII: VN3501T41P)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROGENATED PALM OIL (UNII: 257THB963H)
PALM KERNEL OIL (UNII: B0S90M0233)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PALM OIL (UNII: 5QUO05548Z)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
MICA (UNII: V8A1AW0880)
ERGOTHIONEINE (UNII: BDZ3DQM98W)
SODIUM PHOSPHATE (UNII: SE337SVY37)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
STANNIC OXIDE (UNII: KM7N50LOS6)
CHLORPHENESIN (UNII: I670DAL4SZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-902-60	1 in 1 CARTON	01/01/2025
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 Drug	M020	01/01/2025

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Registrant - Shiseido America Inc. (782677132)

Establishment
Name	Address	ID/FEI	Business Operations
Shiseido America Inc.		782677132	analysis(58411-902) , manufacture(58411-902)