Label: SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 110- octinoxate and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 120- octinoxate and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 130- octinoxate and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 140 (octinox .......NG FOUNDATION 530- octinoxate and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 540- octinoxate and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 550- octinoxate and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 560- octinoxate and titanium dioxide emulsion

  • NDC Code(s): 58411-563-10, 58411-564-10, 58411-565-10, 58411-566-10, view more
    58411-567-10, 58411-568-10, 58411-569-10, 58411-570-10, 58411-571-10, 58411-572-10, 58411-573-10, 58411-574-10, 58411-575-10, 58411-576-10, 58411-577-10, 58411-578-10, 58411-579-10, 58411-580-10, 58411-581-10, 58411-582-10, 58411-583-10, 58411-584-10, 58411-585-10, 58411-586-10, 58411-587-10, 58411-588-10, 58411-589-10, 58411-590-10, 58411-591-10, 58411-592-10
  • Packager: SHISEIDO AMERICAS CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 20, 2020

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

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    OCTINOXATE 6.9%Sunscreen
    TITANIUM DIOXIDE 1.0%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 of 15 or higher and other un 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▪DIPHENYLSILOXY PHENYL TRIMETHICONE▪GLYCERIN▪TRIFLUOROPROPYLDIMETHYL/TRIMETHYLSILOXYSILICATE▪BUTYLENE GLYCOL▪HYDROGENATED POLYDECENE▪PEG-10 DIMETHICONE▪BIS-BUTYLDIMETHICONE POLYGLYCERYL-3▪DISTEARDIMONIUM HECTORITE▪ERYTHRITOL▪XYLITOL▪SORBITAN SESQUIISOSTEARATE▪POLYQUATERNIUM-51▪CITRUS UNSHIU PEEL EXTRACT▪THYMUS SERPYLLUM EXTRACT▪FAGUS SYLVATICA BUD EXTRACT▪HYDROLYZED CONCHIOLIN PROTEIN▪DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER▪DIMETHICONE/PEG-10/15 CROSSPOLYMER▪BARIUM SULFATE▪SYNTHETIC FLUORPHLOGOPITE▪ALUMINUM HYDROXIDE▪POLYSILICONE-2▪DISODIUM EDTA▪STEARIC ACID▪CALCIUM ALUMINUM BOROSILICATE▪TOCOPHEROL▪DIPROPYLENE GLYCOL▪TRIETHOXYCAPRYLYLSILANE▪TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE▪BHT▪ALUMINA▪POLYMETHYLSILSESQUIOXANE▪PHENOXYETHANOL▪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 Bottle Carton - 110 Alabaster

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    RADIANT LIFTING

    Foundation
    Oil-Free

    BROAD SPECTRUM
    SPF 30

    Sunscreen

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 110 Alabaster
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 120 Ivory

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    RADIANT LIFTING

    Foundation
    Oil-Free

    BROAD SPECTRUM
    SPF 30

    Sunscreen

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 120 Ivory
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 130 Opal

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    RADIANT LIFTING

    Foundation
    Oil-Free

    BROAD SPECTRUM
    SPF 30

    Sunscreen

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 130 Opal
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 140 Porcelain

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    RADIANT LIFTING

    Foundation
    Oil-Free

    BROAD SPECTRUM
    SPF 30

    Sunscreen

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 140 Porcelain
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 150 Lace

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    RADIANT LIFTING

    Foundation
    Oil-Free

    BROAD SPECTRUM
    SPF 30

    Sunscreen

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 150 Lace
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 160 Shell

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    RADIANT LIFTING

    Foundation
    Oil-Free

    BROAD SPECTRUM
    SPF 30

    Sunscreen

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 160 Shell
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 210 Birch

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    RADIANT LIFTING

    Foundation
    Oil-Free

    BROAD SPECTRUM
    SPF 30

    Sunscreen

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 210 Birch
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 220 Linen

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    RADIANT LIFTING

    Foundation
    Oil-Free

    BROAD SPECTRUM
    SPF 30

    Sunscreen

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 220 Linen
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 230 Alder

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    RADIANT LIFTING

    Foundation
    Oil-Free

    BROAD SPECTRUM
    SPF 30

    Sunscreen

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 230 Alder
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 240 Quartz

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    RADIANT LIFTING

    Foundation
    Oil-Free

    BROAD SPECTRUM
    SPF 30

    Sunscreen

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 240 Quartz
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 250 Sand

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    RADIANT LIFTING

    Foundation
    Oil-Free

    BROAD SPECTRUM
    SPF 30

    Sunscreen

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 250 Sand
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 260 Cashmere

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    RADIANT LIFTING

    Foundation
    Oil-Free

    BROAD SPECTRUM
    SPF 30

    Sunscreen

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 260 Cashmere
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 310 Silk

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    RADIANT LIFTING

    Foundation
    Oil-Free

    BROAD SPECTRUM
    SPF 30

    Sunscreen

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 310 Silk
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 320 Pine

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    RADIANT LIFTING

    Foundation
    Oil-Free

    BROAD SPECTRUM
    SPF 30

    Sunscreen

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 320 Pine
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 330 Bamboo

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    RADIANT LIFTING

    Foundation
    Oil-Free

    BROAD SPECTRUM
    SPF 30

    Sunscreen

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 330 Bamboo
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 340 Oak

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    RADIANT LIFTING

    Foundation
    Oil-Free

    BROAD SPECTRUM
    SPF 30

    Sunscreen

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 340 Oak
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 350 Maple

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    RADIANT LIFTING

    Foundation
    Oil-Free

    BROAD SPECTRUM
    SPF 30

    Sunscreen

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 350 Maple
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 360 Citrine

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    RADIANT LIFTING

    Foundation
    Oil-Free

    BROAD SPECTRUM
    SPF 30

    Sunscreen

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 360 Citrine
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 410 Sunstone

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    RADIANT LIFTING

    Foundation
    Oil-Free

    BROAD SPECTRUM
    SPF 30

    Sunscreen

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 410 Sunstone
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 420 Bronze

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    RADIANT LIFTING

    Foundation
    Oil-Free

    BROAD SPECTRUM
    SPF 30

    Sunscreen

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 420 Bronze
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 430 Cedar

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    RADIANT LIFTING

    Foundation
    Oil-Free

    BROAD SPECTRUM
    SPF 30

    Sunscreen

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 430 Cedar
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 440 Amber

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    RADIANT LIFTING

    Foundation
    Oil-Free

    BROAD SPECTRUM
    SPF 30

    Sunscreen

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 440 Amber
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 450 Copper

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    RADIANT LIFTING

    Foundation
    Oil-Free

    BROAD SPECTRUM
    SPF 30

    Sunscreen

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 450 Copper
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 460 Topaz

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    RADIANT LIFTING

    Foundation
    Oil-Free

    BROAD SPECTRUM
    SPF 30

    Sunscreen

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 460 Topaz
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 510 Suede

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    RADIANT LIFTING

    Foundation
    Oil-Free

    BROAD SPECTRUM
    SPF 30

    Sunscreen

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 510 Suede
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 520 Rosewood

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    RADIANT LIFTING

    Foundation
    Oil-Free

    BROAD SPECTRUM
    SPF 30

    Sunscreen

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 520 Rosewood
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 530 Henna

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    RADIANT LIFTING

    Foundation
    Oil-Free

    BROAD SPECTRUM
    SPF 30

    Sunscreen

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 530 Henna
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 540 Mahogany

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    RADIANT LIFTING

    Foundation
    Oil-Free

    BROAD SPECTRUM
    SPF 30

    Sunscreen

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 540 Mahogany
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 550 Jasper

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    RADIANT LIFTING

    Foundation
    Oil-Free

    BROAD SPECTRUM
    SPF 30

    Sunscreen

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 550 Jasper
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 560 Obsidian

    SHISEIDO
    GINZA TOKYO

    SYNCHRO SKIN
    RADIANT LIFTING

    Foundation
    Oil-Free

    BROAD SPECTRUM
    SPF 30

    Sunscreen

    30mL NET WT. 1.2 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 560 Obsidian
  • INGREDIENTS AND APPEARANCE
    SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   110
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.484 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.36 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    TANGERINE PEEL (UNII: JU3D414057)  
    THYMUS SERPYLLUM (UNII: 86H4S6K51N)  
    FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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:58411-563-101 in 1 CARTON09/20/2020
    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 FINALpart35209/20/2020
    SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   120
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-564
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.484 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.36 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    TANGERINE PEEL (UNII: JU3D414057)  
    THYMUS SERPYLLUM (UNII: 86H4S6K51N)  
    FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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:58411-564-101 in 1 CARTON09/20/2020
    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 FINALpart35209/20/2020
    SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   130
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-565
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.484 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.36 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    TANGERINE PEEL (UNII: JU3D414057)  
    THYMUS SERPYLLUM (UNII: 86H4S6K51N)  
    FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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:58411-565-101 in 1 CARTON09/20/2020
    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 FINALpart35209/20/2020
    SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   140
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-566
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.484 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.36 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    TANGERINE PEEL (UNII: JU3D414057)  
    THYMUS SERPYLLUM (UNII: 86H4S6K51N)  
    FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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:58411-566-101 in 1 CARTON09/20/2020
    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 FINALpart35209/20/2020
    SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   150
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-567
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.484 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.36 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    TANGERINE PEEL (UNII: JU3D414057)  
    THYMUS SERPYLLUM (UNII: 86H4S6K51N)  
    FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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:58411-567-101 in 1 CARTON09/20/2020
    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 FINALpart35209/20/2020
    SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   160
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-568
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.484 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.36 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    TANGERINE PEEL (UNII: JU3D414057)  
    THYMUS SERPYLLUM (UNII: 86H4S6K51N)  
    FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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:58411-568-101 in 1 CARTON09/20/2020
    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 FINALpart35209/20/2020
    SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   210
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-569
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.484 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.36 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    TANGERINE PEEL (UNII: JU3D414057)  
    THYMUS SERPYLLUM (UNII: 86H4S6K51N)  
    FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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:58411-569-101 in 1 CARTON09/20/2020
    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 FINALpart35209/20/2020
    SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   220
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-570
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.484 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.36 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    TANGERINE PEEL (UNII: JU3D414057)  
    THYMUS SERPYLLUM (UNII: 86H4S6K51N)  
    FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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:58411-570-101 in 1 CARTON09/20/2020
    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 FINALpart35209/20/2020
    SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   230
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-571
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.484 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.36 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    TANGERINE PEEL (UNII: JU3D414057)  
    THYMUS SERPYLLUM (UNII: 86H4S6K51N)  
    FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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:58411-571-101 in 1 CARTON09/20/2020
    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 FINALpart35209/20/2020
    SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   240
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-572
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.484 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.36 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    TANGERINE PEEL (UNII: JU3D414057)  
    THYMUS SERPYLLUM (UNII: 86H4S6K51N)  
    FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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:58411-572-101 in 1 CARTON09/20/2020
    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 FINALpart35209/20/2020
    SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   250
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-573
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.484 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.36 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    TANGERINE PEEL (UNII: JU3D414057)  
    THYMUS SERPYLLUM (UNII: 86H4S6K51N)  
    FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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:58411-573-101 in 1 CARTON09/20/2020
    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 FINALpart35209/20/2020
    SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   260
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-574
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.484 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.36 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    TANGERINE PEEL (UNII: JU3D414057)  
    THYMUS SERPYLLUM (UNII: 86H4S6K51N)  
    FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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:58411-574-101 in 1 CARTON09/20/2020
    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 FINALpart35209/20/2020
    SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   310
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-575
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.484 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.36 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    TANGERINE PEEL (UNII: JU3D414057)  
    THYMUS SERPYLLUM (UNII: 86H4S6K51N)  
    FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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:58411-575-101 in 1 CARTON09/20/2020
    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 FINALpart35209/20/2020
    SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   320
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-576
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.484 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.36 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    TANGERINE PEEL (UNII: JU3D414057)  
    THYMUS SERPYLLUM (UNII: 86H4S6K51N)  
    FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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:58411-576-101 in 1 CARTON09/20/2020
    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 FINALpart35209/20/2020
    SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   330
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-577
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.484 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.36 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    TANGERINE PEEL (UNII: JU3D414057)  
    THYMUS SERPYLLUM (UNII: 86H4S6K51N)  
    FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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:58411-577-101 in 1 CARTON09/20/2020
    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 FINALpart35209/20/2020
    SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   340
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-578
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.484 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.36 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    TANGERINE PEEL (UNII: JU3D414057)  
    THYMUS SERPYLLUM (UNII: 86H4S6K51N)  
    FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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:58411-578-101 in 1 CARTON09/20/2020
    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 FINALpart35209/20/2020
    SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   350
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-579
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.484 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.36 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    TANGERINE PEEL (UNII: JU3D414057)  
    THYMUS SERPYLLUM (UNII: 86H4S6K51N)  
    FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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:58411-579-101 in 1 CARTON09/20/2020
    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 FINALpart35209/20/2020
    SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   360
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-580
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.484 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.36 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    TANGERINE PEEL (UNII: JU3D414057)  
    THYMUS SERPYLLUM (UNII: 86H4S6K51N)  
    FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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:58411-580-101 in 1 CARTON09/20/2020
    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 FINALpart35209/20/2020
    SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   410
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-581
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.484 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.36 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    TANGERINE PEEL (UNII: JU3D414057)  
    THYMUS SERPYLLUM (UNII: 86H4S6K51N)  
    FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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:58411-581-101 in 1 CARTON09/20/2020
    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 FINALpart35209/20/2020
    SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   420
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-582
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.484 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.36 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    TANGERINE PEEL (UNII: JU3D414057)  
    THYMUS SERPYLLUM (UNII: 86H4S6K51N)  
    FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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:58411-582-101 in 1 CARTON09/20/2020
    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 FINALpart35209/20/2020
    SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   430
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-583
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.484 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.36 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    TANGERINE PEEL (UNII: JU3D414057)  
    THYMUS SERPYLLUM (UNII: 86H4S6K51N)  
    FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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:58411-583-101 in 1 CARTON09/20/2020
    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 FINALpart35209/20/2020
    SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   440
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-584
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.484 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.36 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    TANGERINE PEEL (UNII: JU3D414057)  
    THYMUS SERPYLLUM (UNII: 86H4S6K51N)  
    FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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:58411-584-101 in 1 CARTON09/20/2020
    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 FINALpart35209/20/2020
    SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   450
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-585
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.484 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.36 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    TANGERINE PEEL (UNII: JU3D414057)  
    THYMUS SERPYLLUM (UNII: 86H4S6K51N)  
    FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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:58411-585-101 in 1 CARTON09/20/2020
    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 FINALpart35209/20/2020
    SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   460
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-586
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.484 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.36 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    TANGERINE PEEL (UNII: JU3D414057)  
    THYMUS SERPYLLUM (UNII: 86H4S6K51N)  
    FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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:58411-586-101 in 1 CARTON09/20/2020
    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 FINALpart35209/20/2020
    SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   510
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-587
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.484 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.36 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    TANGERINE PEEL (UNII: JU3D414057)  
    THYMUS SERPYLLUM (UNII: 86H4S6K51N)  
    FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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:58411-587-101 in 1 CARTON09/20/2020
    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 FINALpart35209/20/2020
    SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   520
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-588
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.484 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.36 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    TANGERINE PEEL (UNII: JU3D414057)  
    THYMUS SERPYLLUM (UNII: 86H4S6K51N)  
    FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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:58411-588-101 in 1 CARTON09/20/2020
    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 FINALpart35209/20/2020
    SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   530
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-589
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.484 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.36 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    TANGERINE PEEL (UNII: JU3D414057)  
    THYMUS SERPYLLUM (UNII: 86H4S6K51N)  
    FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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:58411-589-101 in 1 CARTON09/20/2020
    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 FINALpart35209/20/2020
    SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   540
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-590
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.484 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.36 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    TANGERINE PEEL (UNII: JU3D414057)  
    THYMUS SERPYLLUM (UNII: 86H4S6K51N)  
    FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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:58411-590-101 in 1 CARTON09/20/2020
    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 FINALpart35209/20/2020
    SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   550
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-591
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.484 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.36 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    TANGERINE PEEL (UNII: JU3D414057)  
    THYMUS SERPYLLUM (UNII: 86H4S6K51N)  
    FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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:58411-591-101 in 1 CARTON09/20/2020
    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 FINALpart35209/20/2020
    SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   560
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-592
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.484 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.36 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    TANGERINE PEEL (UNII: JU3D414057)  
    THYMUS SERPYLLUM (UNII: 86H4S6K51N)  
    FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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:58411-592-101 in 1 CARTON09/20/2020
    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 FINALpart35209/20/2020
    Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
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