Label: SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 115 FAIR SHIRAKABA- octinoxate, octocrylene, and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 125 FAIR ASTERID- octinoxate, octocrylene, and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 215 LIGHT BUNA- octinoxate, octocrylene, and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 225 LIGHT MAGNOLIA- octinoxate, octocrylene, and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 235 LIGHT HIBA- octinoxate, octocrylene, and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 315 MEDIUM MATSU- octinoxate, octocrylene, and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 325 MEDIUM KEYAKI- octinoxate, octocrylene, and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 335 MEDIUM KATSURA- octinoxate, octocrylene, and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 415 TAN KWANZAN- octinoxate, octocrylene, and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 425 TAN UME- octinoxate, octocrylene, and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 515 DEEP TSUBAKI- octinoxate, octocrylene, and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 525 DEEP KUROMOJI- octinoxate, octocrylene, and titanium dioxide emulsion

  • NDC Code(s): 58411-673-20, 58411-674-20, 58411-675-20, 58411-676-20, view more
    58411-677-20, 58411-678-20, 58411-679-20, 58411-680-20, 58411-681-20, 58411-682-20, 58411-683-20, 58411-684-20
  • Packager: SHISEIDO AMERICAS CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 12, 2022

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Octinoxate 4.7%Sunscreen
    Octocrylene 3.0%Sunscreen
    Titanium Dioxide 2.0%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, flame, or while 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 2 hours
    • children under 6 months: Ask a doctor
    • 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 value 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
  • Inactive Ingredients

    WATER•DIMETHICONE•GLYCERIN•TRIFLUOROPROPYLDIMETHYL/TRIMETHYLSILOXYSILICATE•CAPRYLYL METHICONE•BUTYLENE GLYCOL•DIMETHICONE/PEG-10/15 CROSSPOLYMER•SODIUM CHLORIDE•SYNTHETIC FLUORHLOGOPITE•SQUALANE•HYDROGENATED POLYISOBUTENE•THYMUS SERPYLLUM EXTRACT•DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER•POLYQUATERNIUM-51•SODIUM HYALURONATE•HYDROLYZED CONCHIOLIN PROTEIN•SORBITAN SESQUIISOSTEARATE•DISTEARDIMONIUM HECTORITE•PEG-10 DIMETHICONE•ALUMINUM HYDROXIDE•STEARIC ACID•TRISODIUM EDTA•HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER•LITHIUM MAGNESIUM SODIUM SILICATE•POLYSILICONE-2•SODIUM CITRATE•DIPROPYLENE GLYCOL•POLYSORBATE 60•ISODODECANE•PEG/PPG-19/19 DIMETHICONE•BHT•TOCOPHEROL•SORBITAN ISOSTEARATE•TRIMETHYLSILOXYSILYLCARBAMOYL PULLULAN•POLYMETHYLSILSESQUIOXANE•PHENOXYETHANOL•IRON OXIDES•TITANIUM DIOXIDE•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 Bottle Carton - 115 Fair Shirakaba

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    SELF-REFRESHING

    Tint

    BROAD SPECTRUM
    SPF 20

    Sunscreen
    For Face

    30mL NET WT. .95 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 115 Fair Shirakaba
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 125 Fair Asterid

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    SELF-REFRESHING

    Tint

    BROAD SPECTRUM
    SPF 20

    Sunscreen
    For Face

    30mL NET WT. .95 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 125 Fair Asterid
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 215 Light Buna

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    SELF-REFRESHING

    Tint

    BROAD SPECTRUM
    SPF 20

    Sunscreen
    For Face

    30mL NET WT. .95 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 215 Light Buna
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 225 Light Magnolia

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    SELF-REFRESHING

    Tint

    BROAD SPECTRUM
    SPF 20

    Sunscreen
    For Face

    30mL NET WT. .95 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 225 Light Magnolia
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 235 Light Hiba

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    SELF-REFRESHING

    Tint

    BROAD SPECTRUM
    SPF 20

    Sunscreen
    For Face

    30mL NET WT. .95 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 235 Light Hiba
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 315 Medium Matsu

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    SELF-REFRESHING

    Tint

    BROAD SPECTRUM
    SPF 20

    Sunscreen
    For Face

    30mL NET WT. .95 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 315 Medium Matsu
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 325 Medium Keyaki

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    SELF-REFRESHING

    Tint

    BROAD SPECTRUM
    SPF 20

    Sunscreen
    For Face

    30mL NET WT. .95 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 325 Medium Keyaki
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 335 Medium Katsura

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    SELF-REFRESHING

    Tint

    BROAD SPECTRUM
    SPF 20

    Sunscreen
    For Face

    30mL NET WT. .95 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 335 Medium Katsura
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 415 Tan Kwanzan

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    SELF-REFRESHING

    Tint

    BROAD SPECTRUM
    SPF 20

    Sunscreen
    For Face

    30mL NET WT. .95 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 415 Tan Kwanzan
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 425 Tan Ume

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    SELF-REFRESHING

    Tint

    BROAD SPECTRUM
    SPF 20

    Sunscreen
    For Face

    30mL NET WT. .95 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 425 Tan Ume
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 515 Deep Tsubaki

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    SELF-REFRESHING

    Tint

    BROAD SPECTRUM
    SPF 20

    Sunscreen
    For Face

    30mL NET WT. .95 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 515 Deep Tsubaki
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 525 Deep Kuromoji

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    SELF-REFRESHING

    Tint

    BROAD SPECTRUM
    SPF 20

    Sunscreen
    For Face

    30mL NET WT. .95 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 525 Deep Kuromoji
  • INGREDIENTS AND APPEARANCE
    SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT  115 FAIR SHIRAKABA
    octinoxate, octocrylene, and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-673
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2010 mg  in 30 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE900 mg  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE600 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    LAPONITE (UNII: D703131383)  
    SQUALANE (UNII: GW89575KF9)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    ISODODECANE (UNII: A8289P68Y2)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MICA (UNII: V8A1AW0880)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-673-201 in 1 CONTAINER12/16/2019
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02012/16/2019
    SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT  125 FAIR ASTERID
    octinoxate, octocrylene, and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-674
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2010 mg  in 30 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE900 mg  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE600 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    LAPONITE (UNII: D703131383)  
    SQUALANE (UNII: GW89575KF9)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    ISODODECANE (UNII: A8289P68Y2)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MICA (UNII: V8A1AW0880)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-674-201 in 1 CONTAINER12/16/2019
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02012/16/2019
    SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT  215 LIGHT BUNA
    octinoxate, octocrylene, and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-675
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2010 mg  in 30 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE900 mg  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE600 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    LAPONITE (UNII: D703131383)  
    SQUALANE (UNII: GW89575KF9)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    ISODODECANE (UNII: A8289P68Y2)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MICA (UNII: V8A1AW0880)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-675-201 in 1 CONTAINER12/16/2019
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02012/16/2019
    SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT  225 LIGHT MAGNOLIA
    octinoxate, octocrylene, and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-676
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2010 mg  in 30 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE900 mg  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE600 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    LAPONITE (UNII: D703131383)  
    SQUALANE (UNII: GW89575KF9)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    ISODODECANE (UNII: A8289P68Y2)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MICA (UNII: V8A1AW0880)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-676-201 in 1 CONTAINER12/16/2019
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02012/16/2019
    SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT  235 LIGHT HIBA
    octinoxate, octocrylene, and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-677
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2010 mg  in 30 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE900 mg  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE600 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    LAPONITE (UNII: D703131383)  
    SQUALANE (UNII: GW89575KF9)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    ISODODECANE (UNII: A8289P68Y2)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MICA (UNII: V8A1AW0880)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-677-201 in 1 CONTAINER12/16/2019
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02012/16/2019
    SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT  315 MEDIUM MATSU
    octinoxate, octocrylene, and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-678
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2010 mg  in 30 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE900 mg  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE600 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    LAPONITE (UNII: D703131383)  
    SQUALANE (UNII: GW89575KF9)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    ISODODECANE (UNII: A8289P68Y2)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MICA (UNII: V8A1AW0880)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-678-201 in 1 CONTAINER12/16/2019
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02012/16/2019
    SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT  325 MEDIUM KEYAKI
    octinoxate, octocrylene, and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-679
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2010 mg  in 30 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE900 mg  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE600 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    LAPONITE (UNII: D703131383)  
    SQUALANE (UNII: GW89575KF9)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    ISODODECANE (UNII: A8289P68Y2)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MICA (UNII: V8A1AW0880)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-679-201 in 1 CONTAINER12/16/2019
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02012/16/2019
    SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT  335 MEDIUM KATSURA
    octinoxate, octocrylene, and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-680
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2010 mg  in 30 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE900 mg  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE600 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    LAPONITE (UNII: D703131383)  
    SQUALANE (UNII: GW89575KF9)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    ISODODECANE (UNII: A8289P68Y2)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MICA (UNII: V8A1AW0880)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-680-201 in 1 CONTAINER12/16/2019
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02012/16/2019
    SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT  415 TAN KWANZAN
    octinoxate, octocrylene, and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-681
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2010 mg  in 30 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE900 mg  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE600 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    LAPONITE (UNII: D703131383)  
    SQUALANE (UNII: GW89575KF9)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    ISODODECANE (UNII: A8289P68Y2)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MICA (UNII: V8A1AW0880)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-681-201 in 1 CONTAINER12/16/2019
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02012/16/2019
    SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT  425 TAN UME
    octinoxate, octocrylene, and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-682
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2010 mg  in 30 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE900 mg  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE600 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    LAPONITE (UNII: D703131383)  
    SQUALANE (UNII: GW89575KF9)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    ISODODECANE (UNII: A8289P68Y2)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MICA (UNII: V8A1AW0880)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-682-201 in 1 CONTAINER12/16/2019
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02012/16/2019
    SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT  515 DEEP TSUBAKI
    octinoxate, octocrylene, and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-683
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2010 mg  in 30 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE900 mg  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE600 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    LAPONITE (UNII: D703131383)  
    SQUALANE (UNII: GW89575KF9)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    ISODODECANE (UNII: A8289P68Y2)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MICA (UNII: V8A1AW0880)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-683-201 in 1 CONTAINER12/16/2019
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02012/16/2019
    SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT  525 DEEP KUROMOJI
    octinoxate, octocrylene, and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-684
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2010 mg  in 30 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE900 mg  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE600 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    LAPONITE (UNII: D703131383)  
    SQUALANE (UNII: GW89575KF9)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    ISODODECANE (UNII: A8289P68Y2)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MICA (UNII: V8A1AW0880)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-684-201 in 1 CONTAINER12/16/2019
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02012/16/2019
    Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shiseido America Inc.782677132ANALYSIS(58411-673, 58411-674, 58411-675, 58411-676, 58411-677, 58411-678, 58411-679, 58411-680, 58411-681, 58411-682, 58411-683, 58411-684) , MANUFACTURE(58411-673, 58411-674, 58411-675, 58411-676, 58411-677, 58411-678, 58411-679, 58411-680, 58411-681, 58411-682, 58411-683, 58411-684)