Drug Facts

Active ingredients	Purpose
Octinoxate 4.7%	Sunscreen
Octocrylene 3.0%	Sunscreen
Titanium Dioxide 2.0%	Sunscreen

Uses

helps prevent sunburn
if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Flammable

Do not use near heat, flame, or while smoking.

Directions

For sunscreen use:

apply liberally 15 minutes before sun exposure
use a water resistant sunscreen if swimming or sweating
reapply at least every 2 hours
children under 6 months: Ask a doctor
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. – 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses

Inactive Ingredients

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

Other information

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

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 115 Fair Shirakaba

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN
SELF-REFRESHING

Tint

BROAD SPECTRUM
SPF 20

Sunscreen
For Face

30mL NET WT. .95 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 115 Fair Shirakaba

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 125 Fair Asterid

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN
SELF-REFRESHING

Tint

BROAD SPECTRUM
SPF 20

Sunscreen
For Face

30mL NET WT. .95 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 125 Fair Asterid

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 215 Light Buna

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN
SELF-REFRESHING

Tint

BROAD SPECTRUM
SPF 20

Sunscreen
For Face

30mL NET WT. .95 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 215 Light Buna

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 225 Light Magnolia

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN
SELF-REFRESHING

Tint

BROAD SPECTRUM
SPF 20

Sunscreen
For Face

30mL NET WT. .95 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 225 Light Magnolia

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 235 Light Hiba

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN
SELF-REFRESHING

Tint

BROAD SPECTRUM
SPF 20

Sunscreen
For Face

30mL NET WT. .95 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 235 Light Hiba

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 315 Medium Matsu

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN
SELF-REFRESHING

Tint

BROAD SPECTRUM
SPF 20

Sunscreen
For Face

30mL NET WT. .95 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 315 Medium Matsu

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 325 Medium Keyaki

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN
SELF-REFRESHING

Tint

BROAD SPECTRUM
SPF 20

Sunscreen
For Face

30mL NET WT. .95 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 325 Medium Keyaki

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 335 Medium Katsura

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN
SELF-REFRESHING

Tint

BROAD SPECTRUM
SPF 20

Sunscreen
For Face

30mL NET WT. .95 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 335 Medium Katsura

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 415 Tan Kwanzan

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN
SELF-REFRESHING

Tint

BROAD SPECTRUM
SPF 20

Sunscreen
For Face

30mL NET WT. .95 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 415 Tan Kwanzan

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 425 Tan Ume

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN
SELF-REFRESHING

Tint

BROAD SPECTRUM
SPF 20

Sunscreen
For Face

30mL NET WT. .95 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 425 Tan Ume

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 515 Deep Tsubaki

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN
SELF-REFRESHING

Tint

BROAD SPECTRUM
SPF 20

Sunscreen
For Face

30mL NET WT. .95 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 515 Deep Tsubaki

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 525 Deep Kuromoji

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN
SELF-REFRESHING

Tint

BROAD SPECTRUM
SPF 20

Sunscreen
For Face

30mL NET WT. .95 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 525 Deep Kuromoji

SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 115 FAIR SHIRAKABA
octinoxate, octocrylene, and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-673
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2010 mg in 30 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	900 mg in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	600 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
LAPONITE (UNII: D703131383)
SQUALANE (UNII: GW89575KF9)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ISODODECANE (UNII: A8289P68Y2)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
TOCOPHEROL (UNII: R0ZB2556P8)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-673-20	1 in 1 CONTAINER	12/16/2019
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH DRUG	M020	12/16/2019

SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 125 FAIR ASTERID
octinoxate, octocrylene, and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-674
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2010 mg in 30 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	900 mg in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	600 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
LAPONITE (UNII: D703131383)
SQUALANE (UNII: GW89575KF9)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ISODODECANE (UNII: A8289P68Y2)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
TOCOPHEROL (UNII: R0ZB2556P8)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-674-20	1 in 1 CONTAINER	12/16/2019
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH DRUG	M020	12/16/2019

SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 215 LIGHT BUNA
octinoxate, octocrylene, and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-675
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2010 mg in 30 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	900 mg in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	600 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
LAPONITE (UNII: D703131383)
SQUALANE (UNII: GW89575KF9)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ISODODECANE (UNII: A8289P68Y2)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
TOCOPHEROL (UNII: R0ZB2556P8)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-675-20	1 in 1 CONTAINER	12/16/2019
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH DRUG	M020	12/16/2019

SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 225 LIGHT MAGNOLIA
octinoxate, octocrylene, and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-676
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2010 mg in 30 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	900 mg in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	600 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
LAPONITE (UNII: D703131383)
SQUALANE (UNII: GW89575KF9)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ISODODECANE (UNII: A8289P68Y2)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
TOCOPHEROL (UNII: R0ZB2556P8)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-676-20	1 in 1 CONTAINER	12/16/2019
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH DRUG	M020	12/16/2019

SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 235 LIGHT HIBA
octinoxate, octocrylene, and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-677
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2010 mg in 30 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	900 mg in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	600 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
LAPONITE (UNII: D703131383)
SQUALANE (UNII: GW89575KF9)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ISODODECANE (UNII: A8289P68Y2)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
TOCOPHEROL (UNII: R0ZB2556P8)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-677-20	1 in 1 CONTAINER	12/16/2019
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH DRUG	M020	12/16/2019

SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 315 MEDIUM MATSU
octinoxate, octocrylene, and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-678
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2010 mg in 30 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	900 mg in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	600 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
LAPONITE (UNII: D703131383)
SQUALANE (UNII: GW89575KF9)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ISODODECANE (UNII: A8289P68Y2)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
TOCOPHEROL (UNII: R0ZB2556P8)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-678-20	1 in 1 CONTAINER	12/16/2019
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH DRUG	M020	12/16/2019

SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 325 MEDIUM KEYAKI
octinoxate, octocrylene, and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-679
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2010 mg in 30 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	900 mg in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	600 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
LAPONITE (UNII: D703131383)
SQUALANE (UNII: GW89575KF9)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ISODODECANE (UNII: A8289P68Y2)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
TOCOPHEROL (UNII: R0ZB2556P8)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-679-20	1 in 1 CONTAINER	12/16/2019
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH DRUG	M020	12/16/2019

SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 335 MEDIUM KATSURA
octinoxate, octocrylene, and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-680
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2010 mg in 30 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	900 mg in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	600 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
LAPONITE (UNII: D703131383)
SQUALANE (UNII: GW89575KF9)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ISODODECANE (UNII: A8289P68Y2)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
TOCOPHEROL (UNII: R0ZB2556P8)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-680-20	1 in 1 CONTAINER	12/16/2019
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH DRUG	M020	12/16/2019

SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 415 TAN KWANZAN
octinoxate, octocrylene, and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-681
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2010 mg in 30 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	900 mg in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	600 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
LAPONITE (UNII: D703131383)
SQUALANE (UNII: GW89575KF9)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ISODODECANE (UNII: A8289P68Y2)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
TOCOPHEROL (UNII: R0ZB2556P8)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-681-20	1 in 1 CONTAINER	12/16/2019
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH DRUG	M020	12/16/2019

SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 425 TAN UME
octinoxate, octocrylene, and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-682
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2010 mg in 30 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	900 mg in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	600 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
LAPONITE (UNII: D703131383)
SQUALANE (UNII: GW89575KF9)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ISODODECANE (UNII: A8289P68Y2)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
TOCOPHEROL (UNII: R0ZB2556P8)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-682-20	1 in 1 CONTAINER	12/16/2019
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH DRUG	M020	12/16/2019

SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 515 DEEP TSUBAKI
octinoxate, octocrylene, and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-683
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2010 mg in 30 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	900 mg in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	600 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
LAPONITE (UNII: D703131383)
SQUALANE (UNII: GW89575KF9)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ISODODECANE (UNII: A8289P68Y2)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
TOCOPHEROL (UNII: R0ZB2556P8)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-683-20	1 in 1 CONTAINER	12/16/2019
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH DRUG	M020	12/16/2019

SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 525 DEEP KUROMOJI
octinoxate, octocrylene, and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-684
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2010 mg in 30 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	900 mg in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	600 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
LAPONITE (UNII: D703131383)
SQUALANE (UNII: GW89575KF9)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ISODODECANE (UNII: A8289P68Y2)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
TOCOPHEROL (UNII: R0ZB2556P8)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-684-20	1 in 1 CONTAINER	12/16/2019
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH DRUG	M020	12/16/2019

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Name	Address	ID/FEI	Business Operations
Establishment
Shiseido America Inc.		782677132	ANALYSIS(58411-673, 58411-674, 58411-675, 58411-676, 58411-677, 58411-678, 58411-679, 58411-680, 58411-681, 58411-682, 58411-683, 58411-684) , MANUFACTURE(58411-673, 58411-674, 58411-675, 58411-676, 58411-677, 58411-678, 58411-679, 58411-680, 58411-681, 58411-682, 58411-683, 58411-684)