SHISEIDO FUTURE LX UNIVERSAL DEFENSE- octinoxate, octocrylene, oxybenzone, and zinc oxide cream

SHISEIDO FUTURE LX UNIVERSAL DEFENSE by

Drug Labeling and Warnings

SHISEIDO FUTURE LX UNIVERSAL DEFENSE 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
OCTINOXATE 4.9%	Sunscreen
OCTOCRYLENE 3.0%	Sunscreen
OXYBENZONE 1.0%	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.

Directions

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• reapply:
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • 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

WATERISODODECANEBUTYLENE GLYCOLSD ALCOHOL 40-BCAPRYLYL METHICONEDIMETHICONEGLYCERINPEG-60 HYDROGENATED CASTOR OILTOCOPHERYL ACETATEPIPERIDINEPROPIONIC ACIDMAGNESIUM ALUMINUM SILICATE2-O-ETHYL ASCORBIC ACIDSACCHAROMYCES FERMENT LYSATE FILTRATESODIUM ACETYLATED HYALURONATEAVERRHOA CARAMBOLA LEAF EXTRACTGENTIANA URNULA FLOWER EXTRACTCAMELLIA SINENSIS LEAF EXTRACTPEG-100 HYDROGENATED CASTOR OILPPG-17HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMERISOSTEARIC ACIDDIMETHYLACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE CROSSPOLYMERSORBITAN SESQUIISOSTEARATEHYDROGEN DIMETHICONETRIETHOXYCAPRYLYLSILANESUCCINOGLYCANCELLULOSE GUMSODIUM METAPHOSPHATECITRIC ACIDBHTDISODIUM EDTASILICAALUMINASODIUM METABISULFITEALCOHOLSODIUM CITRATETOCOPHEROLTALCPOLYSILICONE-2BARIUM SULFATEPHENOXYETHANOLFRAGRANCETITANIUM DIOXIDEIRON OXIDESMICA

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

SHI SEIDO

FUTURE SOLUTION LX
Universal Defense
BROAD SPECTRUM
SPF 50+
WATER RESISTANT (40 MINUTES)
SUNSCREEN

50mL NET WT. 1.9 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO FUTURE LX UNIVERSAL DEFENSE 
octinoxate, octocrylene, oxybenzone, and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-256
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2717 mg  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1664 mg  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	555 mg  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	8539 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
PPG-17 (UNII: OV0Q322E0U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
ISOSTEARIC ACID (UNII: X33R8U0062)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM OXIDE (UNII: LMI26O6933)
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
ALCOHOL (UNII: 3K9958V90M)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TOCOPHEROL (UNII: R0ZB2556P8)
GENTIANA URNULA FLOWER (UNII: 2RIZ3HY23X)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
TALC (UNII: 7SEV7J4R1U)
AVERRHOA CARAMBOLA LEAF (UNII: HB7UP0QK1T)
BARIUM SULFATE (UNII: 25BB7EKE2E)
MICA (UNII: V8A1AW0880)
WATER (UNII: 059QF0KO0R)
ISODODECANE (UNII: A8289P68Y2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-256-60	1 in 1 CARTON	09/01/2015
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 not final	part352	09/01/2015

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(58411-256) , analysis(58411-256)