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- octinoxate and titanium dioxide emulsion 
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION  150- octinoxate and titanium dioxide emulsion 
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION  160- octinoxate and titanium dioxide emulsion 
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION  210- octinoxate and titanium dioxide emulsion 
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION  220- octinoxate and titanium dioxide emulsion 
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION  230- octinoxate and titanium dioxide emulsion 
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION  240- octinoxate and titanium dioxide emulsion 
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION  250- octinoxate and titanium dioxide emulsion 
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION  260- octinoxate and titanium dioxide emulsion 
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION  310- octinoxate and titanium dioxide emulsion 
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION  320- octinoxate and titanium dioxide emulsion 
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION  330- octinoxate and titanium dioxide emulsion 
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION  340- octinoxate and titanium dioxide emulsion 
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION  350- octinoxate and titanium dioxide emulsion 
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION  360- octinoxate and titanium dioxide emulsion 
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION  410- octinoxate and titanium dioxide emulsion 
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION  420- octinoxate and titanium dioxide emulsion 
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION  430- octinoxate and titanium dioxide emulsion 
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION  440- octinoxate and titanium dioxide emulsion 
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION  450- octinoxate and titanium dioxide emulsion 
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION  460- octinoxate and titanium dioxide emulsion 
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION  510- octinoxate and titanium dioxide emulsion 
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION  520- octinoxate and titanium dioxide emulsion 
SHISEIDO SYNCHRO SKIN RADIANT LIFTING 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 
SHISEIDO AMERICAS CORPORATION

----------

SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION

Drug Facts

Active ingredientsPurpose
OCTINOXATE 6.9%Sunscreen
TITANIUM DIOXIDE 1.0%Sunscreen

Uses

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:

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

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
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 WHOLE (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 DRUGM02009/20/2020
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 WHOLE (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 DRUGM02009/20/2020
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 WHOLE (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 DRUGM02009/20/2020
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 WHOLE (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 DRUGM02009/20/2020
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 WHOLE (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 DRUGM02009/20/2020
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 WHOLE (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 DRUGM02009/20/2020
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 WHOLE (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 DRUGM02009/20/2020
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 WHOLE (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 DRUGM02009/20/2020
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 WHOLE (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 DRUGM02009/20/2020
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 WHOLE (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 DRUGM02009/20/2020
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 WHOLE (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 DRUGM02009/20/2020
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 WHOLE (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 DRUGM02009/20/2020
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 WHOLE (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 DRUGM02009/20/2020
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 WHOLE (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 DRUGM02009/20/2020
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 WHOLE (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 DRUGM02009/20/2020
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 WHOLE (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 DRUGM02009/20/2020
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 WHOLE (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 DRUGM02009/20/2020
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 WHOLE (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 DRUGM02009/20/2020
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 WHOLE (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 DRUGM02009/20/2020
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 WHOLE (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 DRUGM02009/20/2020
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 WHOLE (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 DRUGM02009/20/2020
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 WHOLE (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 DRUGM02009/20/2020
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 WHOLE (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 DRUGM02009/20/2020
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 WHOLE (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 DRUGM02009/20/2020
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 WHOLE (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 DRUGM02009/20/2020
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 WHOLE (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 DRUGM02009/20/2020
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 WHOLE (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 DRUGM02009/20/2020
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 WHOLE (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 DRUGM02009/20/2020
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 WHOLE (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 DRUGM02009/20/2020
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 WHOLE (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 DRUGM02009/20/2020
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
Establishment
NameAddressID/FEIBusiness Operations
Shiseido America Inc.782677132ANALYSIS(58411-563, 58411-564, 58411-565, 58411-566, 58411-567, 58411-568, 58411-569, 58411-570, 58411-571, 58411-572, 58411-573, 58411-574, 58411-575, 58411-576, 58411-577, 58411-578, 58411-579, 58411-580, 58411-581, 58411-582, 58411-583, 58411-584, 58411-585, 58411-586, 58411-587, 58411-588, 58411-589, 58411-590, 58411-591, 58411-592) , MANUFACTURE(58411-563, 58411-564, 58411-565, 58411-566, 58411-567, 58411-568, 58411-569, 58411-570, 58411-571, 58411-572, 58411-573, 58411-574, 58411-575, 58411-576, 58411-577, 58411-578, 58411-579, 58411-580, 58411-581, 58411-582, 58411-583, 58411-584, 58411-585, 58411-586, 58411-587, 58411-588, 58411-589, 58411-590, 58411-591, 58411-592)

Revised: 4/2020
Document Id: fade0d6d-a44e-4a2c-8a2a-4676ec029882
Set id: 8a0da327-a805-4ef9-b69a-14bf7278a81a
Version: 2
Effective Time: 20200420
 
SHISEIDO AMERICAS CORPORATION