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

SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION by

Drug Labeling and Warnings

SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION, Shiseido America Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 560 Obsidian

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN
RADIANT LIFTING

Foundation
Oil-Free

BROAD SPECTRUM
SPF 30

Sunscreen

30mL NET WT. 1.2 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   110
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-563
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.484 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.36 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-563-10	1 in 1 CARTON	09/20/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	09/20/2020

SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   120
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-564
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.484 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.36 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-564-10	1 in 1 CARTON	09/20/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	09/20/2020

SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   130
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-565
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.484 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.36 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-565-10	1 in 1 CARTON	09/20/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	09/20/2020

SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   140
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-566
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.484 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.36 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-566-10	1 in 1 CARTON	09/20/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	09/20/2020

SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   150
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-567
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.484 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.36 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-567-10	1 in 1 CARTON	09/20/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	09/20/2020

SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   160
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-568
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.484 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.36 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-568-10	1 in 1 CARTON	09/20/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	09/20/2020

SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   210
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-569
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.484 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.36 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-569-10	1 in 1 CARTON	09/20/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	09/20/2020

SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   220
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-570
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.484 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.36 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-570-10	1 in 1 CARTON	09/20/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	09/20/2020

SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   230
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-571
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.484 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.36 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-571-10	1 in 1 CARTON	09/20/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	09/20/2020

SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   240
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-572
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.484 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.36 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-572-10	1 in 1 CARTON	09/20/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	09/20/2020

SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   250
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-573
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.484 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.36 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-573-10	1 in 1 CARTON	09/20/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	09/20/2020

SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   260
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-574
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.484 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.36 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-574-10	1 in 1 CARTON	09/20/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	09/20/2020

SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   310
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-575
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.484 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.36 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-575-10	1 in 1 CARTON	09/20/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	09/20/2020

SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   320
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-576
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.484 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.36 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-576-10	1 in 1 CARTON	09/20/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	09/20/2020

SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   330
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-577
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.484 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.36 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-577-10	1 in 1 CARTON	09/20/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	09/20/2020

SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   340
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-578
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.484 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.36 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-578-10	1 in 1 CARTON	09/20/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	09/20/2020

SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   350
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-579
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.484 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.36 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-579-10	1 in 1 CARTON	09/20/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	09/20/2020

SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   360
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-580
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.484 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.36 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-580-10	1 in 1 CARTON	09/20/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	09/20/2020

SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   410
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-581
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.484 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.36 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-581-10	1 in 1 CARTON	09/20/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	09/20/2020

SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   420
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-582
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.484 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.36 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-582-10	1 in 1 CARTON	09/20/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	09/20/2020

SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   430
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-583
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.484 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.36 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-583-10	1 in 1 CARTON	09/20/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	09/20/2020

SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   440
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-584
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.484 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.36 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-584-10	1 in 1 CARTON	09/20/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	09/20/2020

SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   450
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-585
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.484 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.36 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-585-10	1 in 1 CARTON	09/20/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	09/20/2020

SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   460
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-586
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.484 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.36 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-586-10	1 in 1 CARTON	09/20/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	09/20/2020

SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   510
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-587
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.484 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.36 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-587-10	1 in 1 CARTON	09/20/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	09/20/2020

SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   520
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-588
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.484 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.36 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-588-10	1 in 1 CARTON	09/20/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	09/20/2020

SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   530
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-589
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.484 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.36 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-589-10	1 in 1 CARTON	09/20/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	09/20/2020

SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   540
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-590
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.484 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.36 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-590-10	1 in 1 CARTON	09/20/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	09/20/2020

SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   550
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-591
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.484 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.36 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-591-10	1 in 1 CARTON	09/20/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	09/20/2020

SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION   560
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-592
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.484 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.36 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-592-10	1 in 1 CARTON	09/20/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	09/20/2020

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
Shiseido America Inc.		782677132	ANALYSIS(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)