Label: SHISEIDO SYNCHRO SKIN LASTING LIQUID FOUNDATION NEUTRAL 5- octinoxate and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN LASTING LIQUID FOUNDATION ROSE 5- octinoxate and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN LASTING LIQUID FOUNDATION GOLDEN 5- octinoxate and titanium dioxide emulsion

  • NDC Code(s): 58411-624-10, 58411-625-10, 58411-626-10
  • Packager: SHISEIDO AMERICAS CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 13, 2021

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    OCTINOXATE 2.9 %Sunscreen
    TITANIUM DIOXIDE 2.4 %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.

    Flammable; Do not use near heat, flam or white smoking.

  • 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
    • 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

    DIMETHICONE∙WATER∙TRIFLUOROPROPYLDIMETHYL/TRIMETHYLSILOXYSILICATE∙CAPRYLIC/CAPRIC TRIGLYCERIDE∙DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER∙PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE∙SD ALCOHOL 40-B∙MAGNESIUM MYRISTATE∙NYLON-12∙DIPHENYL DIMETHICONE/VINYL DIPHENYL DIMETHICONE/SILSESQUIOXANE CROSSPOLYMER∙DISTEARDIMONIUM HECTORITE∙POLYQUATERNIUM-51∙THYMUS SERPILLUM EXTRACT∙ALUMINUM HYDROXIDE∙ALUMINUM DISTEARATE∙POLYSILICONE-2∙GLYCERIN∙BHT∙ALCOHOL∙BUTYLENE GLYCOL∙TOCOPHEROL∙METHYL METHACRYLATE CROSSPOLYMER∙HYPERICUM ERECTUM FLOWER/LEAF/STEM EXTRACT∙TALC∙DIMETHICONE/PEG-10/15 CROSSPOLYMER∙SILICA∙ALUMINA∙POLYMETHYLSILSESQUIOXANE∙DIISOSTEARYL MALATE∙GLYCERYL DIISOSTEARATE∙DIPROPYLENE GLYCOL∙PHENOXYETHANOL∙FRAGRANCE∙TITANIUM DIOXIDE∙IRON OXIDES∙MICA∙RED 27∙

  • 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 Bottle Carton - Neutral 5

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN

    Lasting
    Liquid Foundation

    Oil Free

    BROAD SPECTRUM
    SPF 20

    Sunscreen

    30mL 1 FL. OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Neutral 5
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Rose 5

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN

    Lasting
    Liquid Foundation

    Oil Free

    BROAD SPECTRUM
    SPF 20

    Sunscreen

    30mL 1 FL. OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Rose 5
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Golden 5

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN

    Lasting
    Liquid Foundation

    Oil Free

    BROAD SPECTRUM
    SPF 20

    Sunscreen

    30mL 1 FL. OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Golden 5
  • INGREDIENTS AND APPEARANCE
    SHISEIDO SYNCHRO SKIN LASTING LIQUID FOUNDATION NEUTRAL 5 
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-624
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.31 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.09 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
    NYLON-12 (UNII: 446U8J075B)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)  
    TALC (UNII: 7SEV7J4R1U)  
    MICA (UNII: V8A1AW0880)  
    DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-624-101 in 1 CARTON01/01/2021
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02001/01/2021
    SHISEIDO SYNCHRO SKIN LASTING LIQUID FOUNDATION ROSE 5 
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-625
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.31 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.09 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
    NYLON-12 (UNII: 446U8J075B)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)  
    TALC (UNII: 7SEV7J4R1U)  
    MICA (UNII: V8A1AW0880)  
    DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-625-101 in 1 CARTON01/01/2021
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02001/01/2021
    SHISEIDO SYNCHRO SKIN LASTING LIQUID FOUNDATION GOLDEN 5 
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-626
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.31 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.09 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
    NYLON-12 (UNII: 446U8J075B)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)  
    TALC (UNII: 7SEV7J4R1U)  
    MICA (UNII: V8A1AW0880)  
    DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-626-101 in 1 CARTON01/01/2021
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02001/01/2021
    Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shiseido America Inc.782677132ANALYSIS(58411-624, 58411-625, 58411-626) , MANUFACTURE(58411-624, 58411-625, 58411-626)