Label: SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 430 CEDAR- octinoxate and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 440 AMBER- octinoxate and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 450 COPPER- octinoxate and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 460 TOPAZ- octinoxate and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 510 SUEDE- octinoxate and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 520 ROSEWOOD- octinoxate and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 530 HENNA- octinoxate and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 540 MAHOGANY- octinoxate and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 550 JASPER- octinoxate and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 560 OBSIDIAN- octinoxate and titanium dioxide emulsion
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NDC Code(s):
58411-504-10,
58411-505-10,
58411-506-10,
58411-507-10, view more58411-508-10, 58411-509-10, 58411-510-10, 58411-511-10, 58411-512-10, 58411-513-10
- Packager: SHISEIDO AMERICAS CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 5, 2026
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
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Directions
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
- children under 6 months: ask a doctor
-
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. – 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
-
Inactive Ingredients
DIMETHICONE • WATER • GLYCERIN • TRIFLUOROPROPYLDIMETHYL/TRIMETHYLSILOXYSILICATE • PHENYL TRIMETHICONE • PEG-10 DIMETHICONE • BUTYLENE GLYCOL • DIMETHICONE CROSSPOLYMER • BIS-BUTYLDIMETHICONE POLYGLYCERYL-3 • SORBITAN SESQUIISOSTEARATE • ISOPROPYL MYRISTATE • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER • NACRE POWDER • MAGNESIUM ALUMINOMETASILICATE • POLYQUATERNIUM-51 • THYMUS SERPYLLUM EXTRACT • SODIUM ACETYLATED HYALURONATE • CYCLOPENTASILOXANE • DISTEARDIMONIUM HECTORITE • POLYSILICONE-2 • POLYMETHYLSILSESQUIOXANE • TRIMETHYLSILOXYSILYLCARBAMOYL PULLULAN • ALUMINUM HYDROXIDE • STEARIC ACID • LITHIUM MAGNESIUM SODIUM SILICATE • PEG/PPG-19/19 DIMETHICONE • CITRIC ACID • SODIUM CITRATE • BHT • SILICA • TOCOPHEROL • PHENOXYETHANOL • IRON OXIDES • TITANIUM DIOXIDE • MICA •
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 430 Cedar
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 440 Amber
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 450 Copper
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 460 Topaz
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 510 Suede
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 520 Rosewood
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 530 Henna
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 540 Mahogany
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 550 Jasper
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 560 Obsidian
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INGREDIENTS AND APPEARANCE
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 430 CEDAR
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-504 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.69 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.345 g in 30 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) SILODRATE (UNII: 9T3UU8T0QK) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) LAPONITE (UNII: D703131383) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-504-10 1 in 1 CARTON 09/01/2019 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 09/01/2019 SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 440 AMBER
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-505 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.69 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.345 g in 30 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) SILODRATE (UNII: 9T3UU8T0QK) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) LAPONITE (UNII: D703131383) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-505-10 1 in 1 CARTON 09/01/2019 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 09/01/2019 SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 450 COPPER
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-506 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.69 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.345 g in 30 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) SILODRATE (UNII: 9T3UU8T0QK) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) LAPONITE (UNII: D703131383) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-506-10 1 in 1 CARTON 09/01/2019 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 09/01/2019 SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 460 TOPAZ
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-507 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.69 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.345 g in 30 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) SILODRATE (UNII: 9T3UU8T0QK) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) LAPONITE (UNII: D703131383) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-507-10 1 in 1 CARTON 09/01/2019 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 09/01/2019 SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 510 SUEDE
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-508 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.69 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.345 g in 30 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) SILODRATE (UNII: 9T3UU8T0QK) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) LAPONITE (UNII: D703131383) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-508-10 1 in 1 CARTON 09/01/2019 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 09/01/2019 SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 520 ROSEWOOD
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-509 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.69 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.345 g in 30 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) SILODRATE (UNII: 9T3UU8T0QK) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) LAPONITE (UNII: D703131383) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-509-10 1 in 1 CARTON 09/01/2019 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 09/01/2019 SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 530 HENNA
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-510 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.69 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.345 g in 30 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) SILODRATE (UNII: 9T3UU8T0QK) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) LAPONITE (UNII: D703131383) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-510-10 1 in 1 CARTON 09/01/2019 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 09/01/2019 SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 540 MAHOGANY
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-511 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.69 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.345 g in 30 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) SILODRATE (UNII: 9T3UU8T0QK) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) LAPONITE (UNII: D703131383) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-511-10 1 in 1 CARTON 09/01/2019 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 09/01/2019 SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 550 JASPER
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-512 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.69 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.345 g in 30 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) SILODRATE (UNII: 9T3UU8T0QK) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) LAPONITE (UNII: D703131383) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-512-10 1 in 1 CARTON 09/01/2019 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 09/01/2019 SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 560 OBSIDIAN
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-513 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.69 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.345 g in 30 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) SILODRATE (UNII: 9T3UU8T0QK) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) LAPONITE (UNII: D703131383) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-513-10 1 in 1 CARTON 09/01/2019 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 09/01/2019 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations Shiseido America Inc. 782677132 analysis(58411-504, 58411-505, 58411-506, 58411-507, 58411-508, 58411-509, 58411-510, 58411-511, 58411-512, 58411-513) , manufacture(58411-504, 58411-505, 58411-506, 58411-507, 58411-508, 58411-509, 58411-510, 58411-511, 58411-512, 58411-513)
