Label: SHISEIDO FUTURE SOLUTION LX UNIVERSAL DEFENSE E- octisalate, octocrylene, and zinc oxide cream
- NDC Code(s): 58411-482-60
- Packager: SHISEIDO AMERICAS CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 17, 2019
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
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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
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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
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
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INGREDIENTS AND APPEARANCE
SHISEIDO FUTURE SOLUTION LX UNIVERSAL DEFENSE E
octisalate, octocrylene, and zinc oxide creamProduct 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)
