SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 430 CEDAR- octinoxate and titanium dioxide emulsion SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 440 AMBER- octinoxate and titanium dioxide emulsion SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 450 COPPER- octinoxate and titanium dioxide emulsion SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 460 TOPAZ- octinoxate and titanium dioxide emulsion SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 510 SUEDE- octinoxate and titanium dioxide emulsion SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 520 ROSEWOOD- octinoxate and titanium dioxide emulsion SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 530 HENNA- octinoxate and titanium dioxide emulsion SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 540 MAHOGANY- octinoxate and titanium dioxide emulsion SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 550 JASPER- octinoxate and titanium dioxide emulsion SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 560 OBSIDIAN- octinoxate and titanium dioxide emulsion

SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 560 OBSIDIAN by

Drug Labeling and Warnings

SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 560 OBSIDIAN 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 4.9%	Sunscreen
Titanium Dioxide 1%	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.

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 sun protection measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses

Inactive Ingredients

DIMETHICONE WATER GLYCERIN TRIFLUOROPROPYLDIMETHYL/TRIMETHYLSILOXYSILICATE PHENYL TRIMETHICONE PEG-10 DIMETHICONE BUTYLENE GLYCOL DIMETHICONE CROSSPOLYMER BIS-BUTYLDIMETHICONE POLYGLYCERYL-3 SORBITAN SESQUIISOSTEARATE ISOPROPYL MYRISTATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER NACRE POWDER MAGNESIUM ALUMINOMETASILICATE POLYQUATERNIUM-51 THYMUS SERPYLLUM EXTRACT SODIUM ACETYLATED HYALURONATE CYCLOPENTASILOXANE DISTEARDIMONIUM HECTORITE POLYSILICONE-2 POLYMETHYLSILSESQUIOXANE TRIMETHYLSILOXYSILYLCARBAMOYL PULLULAN ALUMINUM HYDROXIDE STEARIC ACID LITHIUM MAGNESIUM SODIUM SILICATE PEG/PPG-19/19 DIMETHICONE CITRIC ACID SODIUM CITRATE BHT SILICA TOCOPHEROL PHENOXYETHANOL IRON OXIDES TITANIUM DIOXIDE MICA

Other information

Protect this product in this container from excessive heat and direct sun.

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 430 Cedar

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN
SELF-REFRESHING

Foundation
Oil-Free

BROAD SPECTRUM
SPF 30

Sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 440 Amber

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN
SELF-REFRESHING

Foundation
Oil-Free

BROAD SPECTRUM
SPF 30

Sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 450 Copper

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN
SELF-REFRESHING

Foundation
Oil-Free

BROAD SPECTRUM
SPF 30

Sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 460 Topaz

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN
SELF-REFRESHING

Foundation
Oil-Free

BROAD SPECTRUM
SPF 30

Sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 510 Suede

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN
SELF-REFRESHING

Foundation
Oil-Free

BROAD SPECTRUM
SPF 30

Sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 520 Rosewood

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN
SELF-REFRESHING

Foundation
Oil-Free

BROAD SPECTRUM
SPF 30

Sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 530 Henna

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN
SELF-REFRESHING

Foundation
Oil-Free

BROAD SPECTRUM
SPF 30

Sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 540 Mahogany

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN
SELF-REFRESHING

Foundation
Oil-Free

BROAD SPECTRUM
SPF 30

Sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 550 Jasper

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN
SELF-REFRESHING

Foundation
Oil-Free

BROAD SPECTRUM
SPF 30

Sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 560 Obsidian

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN
SELF-REFRESHING

Foundation
Oil-Free

BROAD SPECTRUM
SPF 30

Sunscreen

30mL 1 FL. OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 430 CEDAR 
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-504
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.69 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.345 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SILODRATE (UNII: 9T3UU8T0QK)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
LAPONITE (UNII: D703131383)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
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: 58411-504-10	1 in 1 CARTON	09/01/2019
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 FINAL	part352	09/01/2019

SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 440 AMBER 
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-505
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.69 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.345 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SILODRATE (UNII: 9T3UU8T0QK)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
LAPONITE (UNII: D703131383)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
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: 58411-505-10	1 in 1 CARTON	09/01/2019
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 FINAL	part352	09/01/2019

SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 450 COPPER 
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-506
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.69 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.345 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SILODRATE (UNII: 9T3UU8T0QK)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
LAPONITE (UNII: D703131383)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
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: 58411-506-10	1 in 1 CARTON	09/01/2019
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 FINAL	part352	09/01/2019

SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 460 TOPAZ 
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-507
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.69 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.345 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SILODRATE (UNII: 9T3UU8T0QK)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
LAPONITE (UNII: D703131383)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
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: 58411-507-10	1 in 1 CARTON	09/01/2019
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 FINAL	part352	09/01/2019

SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 510 SUEDE 
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-508
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.69 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.345 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SILODRATE (UNII: 9T3UU8T0QK)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
LAPONITE (UNII: D703131383)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
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: 58411-508-10	1 in 1 CARTON	09/01/2019
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 FINAL	part352	09/01/2019

SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 520 ROSEWOOD 
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-509
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.69 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.345 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SILODRATE (UNII: 9T3UU8T0QK)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
LAPONITE (UNII: D703131383)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
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: 58411-509-10	1 in 1 CARTON	09/01/2019
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 FINAL	part352	09/01/2019

SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 530 HENNA 
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-510
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.69 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.345 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SILODRATE (UNII: 9T3UU8T0QK)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
LAPONITE (UNII: D703131383)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
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: 58411-510-10	1 in 1 CARTON	09/01/2019
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 FINAL	part352	09/01/2019

SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 540 MAHOGANY 
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-511
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.69 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.345 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SILODRATE (UNII: 9T3UU8T0QK)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
LAPONITE (UNII: D703131383)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
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: 58411-511-10	1 in 1 CARTON	09/01/2019
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 FINAL	part352	09/01/2019

SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 550 JASPER 
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-512
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.69 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.345 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SILODRATE (UNII: 9T3UU8T0QK)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
LAPONITE (UNII: D703131383)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
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: 58411-512-10	1 in 1 CARTON	09/01/2019
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 FINAL	part352	09/01/2019

SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 560 OBSIDIAN 
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-513
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.69 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.345 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SILODRATE (UNII: 9T3UU8T0QK)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
LAPONITE (UNII: D703131383)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
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: 58411-513-10	1 in 1 CARTON	09/01/2019
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 FINAL	part352	09/01/2019

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICAS INC.		782677132	MANUFACTURE(58411-504, 58411-505, 58411-506, 58411-507, 58411-508, 58411-509, 58411-510, 58411-511, 58411-512, 58411-513) , ANALYSIS(58411-504, 58411-505, 58411-506, 58411-507, 58411-508, 58411-509, 58411-510, 58411-511, 58411-512, 58411-513)