Label: SHISEIDO FUTURE SOLUTION LX INFINITE TREATMENT PRIMER- titanium dioxide, octinoxate, and ensulizole emulsion
- NDC Code(s): 58411-657-10
- Packager: SHISEIDO AMERICAS CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 March 26, 2021
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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
- use a water resistant sunscreen if swimming or sweating
- reapply at least every two hours
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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∙DIMETHICONE∙BUTYLENE GLYCOL∙GLYCERIN∙ISOHEXADECANE∙SD ALCOHOL 40-B∙ZEA MAYS (CORN) STARCH∙PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE∙DIPHENYLSILOXY PHENYL TRIMETHICONE∙SILICA∙TRIISOSTEARIN∙DISTEARDIMONIUM HECTORITE∙CETYLETHYLHEXANOATE∙XYLITOL∙ERYTHRITOL∙TRIMETHYLSILOXYSILICATE∙TREHALOSE∙TOCOPHERYL ACETATE∙2-O-ETHYL ASCORBIC ACID∙PRUNUS SPECIOSA LEAF EXTRACT∙ANGELICA ACUTILOBA ROOT EXTRACT∙SCUTELLARIA BAICALENSIS ROOT EXTRACT∙CAMELLIA SINENSIS LEAF EXTRACT∙SODIUM ACETYLATED HYALURONATE∙ISODONIS JAPONICUS LEAF/STALK EXTRACT∙HYDROLYZED CONCHIOLIN PROTEIN∙ROSA ROXBURGHII FRUIT EXTRACT∙GOLD∙TRIETHANOLAMINE∙ISOSTEARIC ACID∙ALUMINUM HYDROXIDE∙STEARIC ACID∙DISODIUM EDTA∙ALCOHOL∙CALCIUM ALUMINUM BOROSILICATE∙BHT∙HYDROGEN DIMETHICONE∙TOCOPHEROL∙POLYSILICONE-2∙TRIETHOXYCAPRYLYLSILANE∙SODIUM CITRATE∙TIN OXIDE∙BARIUM SULFATE∙CITRIC ACID∙PHENOXYETHANOL∙FRAGRANCE∙TITANIUM DIOXIDE∙MICA∙IRON OXIDES
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton
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INGREDIENTS AND APPEARANCE
SHISEIDO FUTURE SOLUTION LX INFINITE TREATMENT PRIMER
titanium dioxide, octinoxate, and ensulizole emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-657 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.77 g in 40 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.71 g in 40 mL ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 0.428 g in 40 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) ISOHEXADECANE (UNII: 918X1OUF1E) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIISOSTEARIN (UNII: 71503RH8KG) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) XYLITOL (UNII: VCQ006KQ1E) CETYL ETHYLHEXANOATE (UNII: 134647WMX4) TROLAMINE (UNII: 9O3K93S3TK) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ERYTHRITOL (UNII: RA96B954X6) MICA (UNII: V8A1AW0880) ISOSTEARIC ACID (UNII: X33R8U0062) PHENOXYETHANOL (UNII: HIE492ZZ3T) TREHALOSE (UNII: B8WCK70T7I) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) EDETATE DISODIUM (UNII: 7FLD91C86K) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ALCOHOL (UNII: 3K9958V90M) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) STANNIC OXIDE (UNII: KM7N50LOS6) PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) GREEN TEA LEAF (UNII: W2ZU1RY8B0) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) BARIUM SULFATE (UNII: 25BB7EKE2E) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) GOLD (UNII: 79Y1949PYO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-657-10 1 in 1 CARTON 05/01/2021 1 40 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 05/01/2021 Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
