Label: SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E GOLDEN 1- octinoxate cream
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E GOLDEN 2- octinoxate cream
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E GOLDEN 3- octinoxate cream
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E GOLDEN 4- octinoxate cream
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E NEUTRAL 1- octinoxate cream
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E NEUTRAL 2- octinoxate cream
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E NEUTRAL 3- octinoxate cream
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E NEUTRAL 4- octinoxate cream
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E ROSE 2- octinoxate cream
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E ROSE 3- octinoxate cream
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E ROSE 4- octinoxate cream

  • NDC Code(s): 58411-329-50, 58411-330-50, 58411-331-50, 58411-332-50, view more
    58411-333-50, 58411-334-50, 58411-335-50, 58411-336-50, 58411-337-50, 58411-338-50, 58411-339-50
  • 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

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    OCTINOXATE 5.9%

  • Purpose

    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
    • use a water resistant sunscreen if swimming or sweating
    • reapply 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

    WATER∙DIMETHICONE∙GLYCERIN∙NYLON-12∙SD ALCOHOL 40-B∙DIETHYLHEXYL SUCCINATE∙PEG-150∙PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE∙PEG-10 DIMETHICONE∙CYCLOHEXASILOXANE∙SORBITAN SESQUIISOSTEARATE∙POTASSIUM METHOXYSALICYLATE∙TRIMETHYLSILOXYSILICATE∙PIPERIDINEPROPIONIC ACID∙TOCOPHERYL ACETATE∙DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER∙2-O-ETHYL ASCORBIC ACID∙POLYMETHYL METHACRYLATE∙PRUNUS SPECIOSA LEAF EXTRACT∙ANGELICA ACUTILOBA ROOT EXTRACT∙SODIUM ACETYLATED HYALURONATE∙ISODONIS JAPONICUS LEAF/STALK EXTRACT∙CAMELLIA SINENSIS LEAF EXTRACT∙DISTEARDIMONIUM HECTORITE∙ISODODECANE∙ALUMINUM HYDROXIDE∙DIMETHICONE/PEG-10/15 CROSSPOLYMER∙POLYSILICONE-2∙TRISODIUM EDTA∙BUTYLENE GLYCOL∙SODIUM CITRATE∙BHT∙BARIUM SULFATE∙TOCOPHEROL∙CITRIC ACID∙SODIUM METABISULFITE∙ALCOHOL∙POLYMETHYLSILSESQUIOXANE∙DIPROPYLENE GLYCOL∙ALUMINA∙PHENOXYETHANOL∙FRAGRANCE∙TITANIUM DIOXIDE∙IRON OXIDES∙MICA∙

  • 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 - 30 mL Jar Carton - Golden 1

    SHI SEIDO
    GINZA TOKYO

    FUTURE SOLUTION LX
    Total Radiance Foundation

    SkingenecellEnmei

    BROAD SPECTRUM SPF 20
    SUNSCREEN

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Golden 1
  • PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Golden 2

    SHI SEIDO
    GINZA TOKYO

    FUTURE SOLUTION LX
    Total Radiance Foundation

    SkingenecellEnmei

    BROAD SPECTRUM SPF 20
    SUNSCREEN

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Golden 2
  • PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Golden 3

    SHI SEIDO
    GINZA TOKYO

    FUTURE SOLUTION LX
    Total Radiance Foundation

    SkingenecellEnmei

    BROAD SPECTRUM SPF 20
    SUNSCREEN

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Golden 3
  • PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Golden 4

    SHI SEIDO
    GINZA TOKYO

    FUTURE SOLUTION LX
    Total Radiance Foundation

    SkingenecellEnmei

    BROAD SPECTRUM SPF 20
    SUNSCREEN

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Golden 4
  • PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Neutral 1

    SHI SEIDO
    GINZA TOKYO

    FUTURE SOLUTION LX
    Total Radiance Foundation

    SkingenecellEnmei

    BROAD SPECTRUM SPF 20
    SUNSCREEN

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Neutral 1
  • PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Neutral 2

    SHI SEIDO
    GINZA TOKYO

    FUTURE SOLUTION LX
    Total Radiance Foundation

    SkingenecellEnmei

    BROAD SPECTRUM SPF 20
    SUNSCREEN

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Neutral 2
  • PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Neutral 3

    SHI SEIDO
    GINZA TOKYO

    FUTURE SOLUTION LX
    Total Radiance Foundation

    SkingenecellEnmei

    BROAD SPECTRUM SPF 20
    SUNSCREEN

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Neutral 3
  • PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Neutral 4

    SHI SEIDO
    GINZA TOKYO

    FUTURE SOLUTION LX
    Total Radiance Foundation

    SkingenecellEnmei

    BROAD SPECTRUM SPF 20
    SUNSCREEN

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Neutral 4
  • PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Rose 2

    SHI SEIDO
    GINZA TOKYO

    FUTURE SOLUTION LX
    Total Radiance Foundation

    SkingenecellEnmei

    BROAD SPECTRUM SPF 20
    SUNSCREEN

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Rose 2
  • PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Rose 3

    SHI SEIDO
    GINZA TOKYO

    FUTURE SOLUTION LX
    Total Radiance Foundation

    SkingenecellEnmei

    BROAD SPECTRUM SPF 20
    SUNSCREEN

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Rose 3
  • PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Rose 4

    SHI SEIDO
    GINZA TOKYO

    FUTURE SOLUTION LX
    Total Radiance Foundation

    SkingenecellEnmei

    BROAD SPECTRUM SPF 20
    SUNSCREEN

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Rose 4
  • INGREDIENTS AND APPEARANCE
    SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E   GOLDEN 1
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-329
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2036 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NYLON-12 (UNII: 446U8J075B)  
    DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
    POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ISODODECANE (UNII: A8289P68Y2)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-329-501 in 1 CARTON08/01/2017
    130 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/01/2017
    SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E   GOLDEN 2
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-330
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1832 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NYLON-12 (UNII: 446U8J075B)  
    DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
    POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ISODODECANE (UNII: A8289P68Y2)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-330-501 in 1 CARTON08/01/2017
    130 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/01/2017
    SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E   GOLDEN 3
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-331
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1832 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NYLON-12 (UNII: 446U8J075B)  
    DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
    POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ISODODECANE (UNII: A8289P68Y2)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-331-501 in 1 CARTON08/01/2017
    130 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/01/2017
    SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E   GOLDEN 4
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-332
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1832 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NYLON-12 (UNII: 446U8J075B)  
    DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
    POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ISODODECANE (UNII: A8289P68Y2)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-332-501 in 1 CARTON08/01/2017
    130 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/01/2017
    SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E   NEUTRAL 1
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-333
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1832 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NYLON-12 (UNII: 446U8J075B)  
    DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
    POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ISODODECANE (UNII: A8289P68Y2)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-333-501 in 1 CARTON08/01/2017
    130 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/01/2017
    SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E   NEUTRAL 2
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-334
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1832 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NYLON-12 (UNII: 446U8J075B)  
    DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
    POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ISODODECANE (UNII: A8289P68Y2)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-334-501 in 1 CARTON08/01/2017
    130 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/01/2017
    SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E   NEUTRAL 3
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-335
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1832 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NYLON-12 (UNII: 446U8J075B)  
    DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
    POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ISODODECANE (UNII: A8289P68Y2)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-335-501 in 1 CARTON08/01/2017
    130 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/01/2017
    SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E   NEUTRAL 4
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-336
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1832 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NYLON-12 (UNII: 446U8J075B)  
    DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
    POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ISODODECANE (UNII: A8289P68Y2)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-336-501 in 1 CARTON08/01/2017
    130 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/01/2017
    SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E   ROSE 2
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-337
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1832 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NYLON-12 (UNII: 446U8J075B)  
    DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
    POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ISODODECANE (UNII: A8289P68Y2)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-337-501 in 1 CARTON08/01/2017
    130 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/01/2017
    SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E   ROSE 3
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-338
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1832 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NYLON-12 (UNII: 446U8J075B)  
    DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
    POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ISODODECANE (UNII: A8289P68Y2)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-338-501 in 1 CARTON08/01/2017
    130 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/01/2017
    SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E   ROSE 4
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-339
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1832 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NYLON-12 (UNII: 446U8J075B)  
    DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
    POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ISODODECANE (UNII: A8289P68Y2)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-339-501 in 1 CARTON08/01/2017
    130 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/01/2017
    Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
    Establishment
    NameAddressID/FEIBusiness Operations
    SHISEIDO AMERICA INC.782677132manufacture(58411-329, 58411-330, 58411-331, 58411-332, 58411-333, 58411-334, 58411-335, 58411-336, 58411-337, 58411-338, 58411-339) , analysis(58411-329, 58411-330, 58411-331, 58411-332, 58411-333, 58411-334, 58411-335, 58411-336, 58411-337, 58411-338, 58411-339)