Label: SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 115 FAIR SHIRAKABA- octinoxate, octocrylene, and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 125 FAIR ASTERID- octinoxate, octocrylene, and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 215 LIGHT BUNA- octinoxate, octocrylene, and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 225 LIGHT MAGNOLIA- octinoxate, octocrylene, and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 235 LIGHT HIBA- octinoxate, octocrylene, and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 315 MEDIUM MATSU- octinoxate, octocrylene, and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 325 MEDIUM KEYAKI- octinoxate, octocrylene, and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 335 MEDIUM KATSURA- octinoxate, octocrylene, and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 415 TAN KWANZAN- octinoxate, octocrylene, and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 425 TAN UME- octinoxate, octocrylene, and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 515 DEEP TSUBAKI- octinoxate, octocrylene, and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 525 DEEP KUROMOJI- octinoxate, octocrylene, and titanium dioxide emulsion
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NDC Code(s):
58411-673-20,
58411-674-20,
58411-675-20,
58411-676-20, view more58411-677-20, 58411-678-20, 58411-679-20, 58411-680-20, 58411-681-20, 58411-682-20, 58411-683-20, 58411-684-20
- Packager: SHISEIDO AMERICAS CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 12, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
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
-
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
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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
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 115 Fair Shirakaba
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 125 Fair Asterid
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 215 Light Buna
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 225 Light Magnolia
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 235 Light Hiba
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 315 Medium Matsu
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 325 Medium Keyaki
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 335 Medium Katsura
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 415 Tan Kwanzan
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 425 Tan Ume
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 515 Deep Tsubaki
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 525 Deep Kuromoji
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INGREDIENTS AND APPEARANCE
SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 115 FAIR SHIRAKABA
octinoxate, octocrylene, and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-673 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH DRUG M020 12/16/2019 SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 125 FAIR ASTERID
octinoxate, octocrylene, and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-674 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH DRUG M020 12/16/2019 SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 215 LIGHT BUNA
octinoxate, octocrylene, and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-675 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH DRUG M020 12/16/2019 SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 225 LIGHT MAGNOLIA
octinoxate, octocrylene, and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-676 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH DRUG M020 12/16/2019 SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 235 LIGHT HIBA
octinoxate, octocrylene, and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-677 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH DRUG M020 12/16/2019 SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 315 MEDIUM MATSU
octinoxate, octocrylene, and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-678 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH DRUG M020 12/16/2019 SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 325 MEDIUM KEYAKI
octinoxate, octocrylene, and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-679 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH DRUG M020 12/16/2019 SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 335 MEDIUM KATSURA
octinoxate, octocrylene, and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-680 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH DRUG M020 12/16/2019 SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 415 TAN KWANZAN
octinoxate, octocrylene, and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-681 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH DRUG M020 12/16/2019 SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 425 TAN UME
octinoxate, octocrylene, and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-682 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH DRUG M020 12/16/2019 SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 515 DEEP TSUBAKI
octinoxate, octocrylene, and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-683 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH DRUG M020 12/16/2019 SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 525 DEEP KUROMOJI
octinoxate, octocrylene, and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-684 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH DRUG M020 12/16/2019 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations 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)