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
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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 POLYBUTENE (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 NOT FINAL part352 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 POLYBUTENE (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 NOT FINAL part352 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 POLYBUTENE (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 NOT FINAL part352 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 POLYBUTENE (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 NOT FINAL part352 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 POLYBUTENE (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 NOT FINAL part352 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 POLYBUTENE (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 NOT FINAL part352 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 POLYBUTENE (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 NOT FINAL part352 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 POLYBUTENE (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 NOT FINAL part352 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 POLYBUTENE (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 NOT FINAL part352 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 POLYBUTENE (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 NOT FINAL part352 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 POLYBUTENE (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 NOT FINAL part352 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 POLYBUTENE (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 NOT FINAL part352 12/16/2019 Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
