Label: SHISEIDO FUTURE SOLUTION LX TOTAL PROTECTIVE E- avobenzone, octinoxate, octocrylene, and oxybenzone cream
- NDC Code(s): 58411-328-50, 58411-328-51
- 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 March 26, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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∙GLYCERIN∙DIPROPYLENE GLYCOL∙BEHENYL ALCOHOL∙BUTYLENE GLYCOL∙ISOHEXADECANE∙SD ALCOHOL 40-B∙SILICA∙CAPRYLIC/CAPRIC TRIGLYCERIDE∙MYRISTYL MYRISTATE∙DIMETHICONE∙POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER∙SORBITOL∙STEARYL ALCOHOL∙PHYTOSTERYL MACADAMIATE∙TOCOPHERYL ACETATE∙PEG/PPG-17/4 DIMETHYL ETHER∙PIPERIDINEPROPIONIC ACID∙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∙BEHENETH-20∙SUCCINOGLYCAN∙TRISODIUM EDTA∙SODIUM CITRATE∙ALCOHOL∙BHT∙SODIUM METAPHOSPHATE∙CITRIC ACID∙TALC∙DEXTRIN PALMITATE∙TOCOPHEROL∙METHYLPARABEN∙ETHYLPARABEN∙FRAGRANCE∙IRON OXIDES∙
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 50 mL Jar Carton
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INGREDIENTS AND APPEARANCE
SHISEIDO FUTURE SOLUTION LX TOTAL PROTECTIVE E
avobenzone, octinoxate, octocrylene, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-328 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1017 mg in 50 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3763 mg in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1526 mg in 50 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 763 mg in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) DIPROPYLENE GLYCOL (UNII: E107L85C40) DOCOSANOL (UNII: 9G1OE216XY) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ISOHEXADECANE (UNII: 918X1OUF1E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) DIMETHICONE (UNII: 92RU3N3Y1O) SORBITOL (UNII: 506T60A25R) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K) PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO) 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) BEHENETH-20 (UNII: BJ4GP2IFLN) EDETATE TRISODIUM (UNII: 420IP921MB) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) ALCOHOL (UNII: 3K9958V90M) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) TALC (UNII: 7SEV7J4R1U) DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-328-50 1 in 1 CARTON 08/01/2017 1 50 mL in 1 JAR; Type 0: Not a Combination Product 2 NDC:58411-328-51 1 in 1 CARTON 05/01/2021 2 30 mL in 1 JAR; 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(58411-328) , analysis(58411-328)
