Label: SHISEIDO FUTURE SOLUTION LX TOTAL PROTECTIVE- avobenzone, octinoxate, octocrylene, and oxybenzone emulsion
- NDC Code(s): 58411-327-10
- 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 December 13, 2018
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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 2 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∙DIPROPYLENE GLYCOL∙SD ALCOHOL 40-B∙GLYCERIN∙HYDROGENATED POLYDECENE∙XYLITOL∙ISODODECANE∙DIMETHICONE∙PEG-5 GLYCERYL STEARATE∙ISOSTEARIC ACID∙SILICA∙PHENYL TRIMETHICONE∙TRIETHANOLAMINE∙XANTHAN GUM∙TOCOPHERYL ACETATE∙PEG/PPG-17/4 DIMETHYL ETHER∙PIPERIDINEPROPIONIC ACID∙PHYTOSTERYL MACADAMIATE∙2-O-ETHYL ASCORBIC ACID∙PRUNUS SPECIOSA LEAF EXTRACT∙ANGELICA ACUTILOBA ROOT EXTRACT∙ISODONIS JAPONICUS LEAF/STALK EXTRACT∙CAMELLIA SINENSIS LEAF EXTRACT∙ZANTHOXYLUM PIPERITUM PEEL EXTRACT∙PPG-17∙GLYCERYL STEARATE SE∙BEHENYL ALCOHOL∙BEHENIC ACID∙STEARIC ACID∙BATYL ALCOHOL∙PEG-30 PHYTOSTEROL∙BUTYLENE GLYCOL∙CARBOMER∙DISODIUM EDTA∙ALCOHOL∙BHT∙CELLULOSE GUM∙SODIUM METAPHOSPHATE∙TALC∙DEXTRIN PALMITATE∙TOCOPHEROL∙ETHYLPARABEN∙METHYLPARABEN∙FRAGRANCE∙IRON OXIDES∙
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 75 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
SHISEIDO FUTURE SOLUTION LX TOTAL PROTECTIVE
avobenzone, octinoxate, octocrylene, and oxybenzone emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-327 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1136 mg in 75 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 5606 mg in 75 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1515 mg in 75 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 758 mg in 75 mL Inactive Ingredients Ingredient Name Strength PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO) PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M) 2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K) PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M) PPG-17 (UNII: OV0Q322E0U) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) DOCOSANOL (UNII: 9G1OE216XY) BEHENIC ACID (UNII: H390488X0A) STEARIC ACID (UNII: 4ELV7Z65AP) BATILOL (UNII: 39YR661C4U) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) EDETATE DISODIUM (UNII: 7FLD91C86K) ALCOHOL (UNII: 3K9958V90M) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) TALC (UNII: 7SEV7J4R1U) DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) ETHYLPARABEN (UNII: 14255EXE39) METHYLPARABEN (UNII: A2I8C7HI9T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) WATER (UNII: 059QF0KO0R) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7) XYLITOL (UNII: VCQ006KQ1E) ISODODECANE (UNII: A8289P68Y2) DIMETHICONE (UNII: 92RU3N3Y1O) PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872) ISOSTEARIC ACID (UNII: X33R8U0062) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) TROLAMINE (UNII: 9O3K93S3TK) XANTHAN GUM (UNII: TTV12P4NEE) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-327-10 1 in 1 CARTON 08/01/2017 1 75 mL in 1 BOTTLE, PLASTIC; 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 08/01/2017 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 manufacture(58411-327) , analysis(58411-327)
