Label: SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 110- octinoxate and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 120- octinoxate and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 130- octinoxate and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 140 (octinox .......NG FOUNDATION 530- octinoxate and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 540- octinoxate and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 550- octinoxate and titanium dioxide emulsion
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 560- octinoxate and titanium dioxide emulsion
-
NDC Code(s):
58411-563-10,
58411-564-10,
58411-565-10,
58411-566-10, view more58411-567-10, 58411-568-10, 58411-569-10, 58411-570-10, 58411-571-10, 58411-572-10, 58411-573-10, 58411-574-10, 58411-575-10, 58411-576-10, 58411-577-10, 58411-578-10, 58411-579-10, 58411-580-10, 58411-581-10, 58411-582-10, 58411-583-10, 58411-584-10, 58411-585-10, 58411-586-10, 58411-587-10, 58411-588-10, 58411-589-10, 58411-590-10, 58411-591-10, 58411-592-10
- Packager: SHISEIDO AMERICAS CORPORATION
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated April 20, 2020
If you are a healthcare professional or from the pharmaceutical industry 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 of 15 or higher and other un protection measures including:
- limit time in the sun, especially from 10 a.m. – 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
-
Inactive Ingredients
WATER▪DIMETHICONE▪DIPHENYLSILOXY PHENYL TRIMETHICONE▪GLYCERIN▪TRIFLUOROPROPYLDIMETHYL/TRIMETHYLSILOXYSILICATE▪BUTYLENE GLYCOL▪HYDROGENATED POLYDECENE▪PEG-10 DIMETHICONE▪BIS-BUTYLDIMETHICONE POLYGLYCERYL-3▪DISTEARDIMONIUM HECTORITE▪ERYTHRITOL▪XYLITOL▪SORBITAN SESQUIISOSTEARATE▪POLYQUATERNIUM-51▪CITRUS UNSHIU PEEL EXTRACT▪THYMUS SERPYLLUM EXTRACT▪FAGUS SYLVATICA BUD EXTRACT▪HYDROLYZED CONCHIOLIN PROTEIN▪DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER▪DIMETHICONE/PEG-10/15 CROSSPOLYMER▪BARIUM SULFATE▪SYNTHETIC FLUORPHLOGOPITE▪ALUMINUM HYDROXIDE▪POLYSILICONE-2▪DISODIUM EDTA▪STEARIC ACID▪CALCIUM ALUMINUM BOROSILICATE▪TOCOPHEROL▪DIPROPYLENE GLYCOL▪TRIETHOXYCAPRYLYLSILANE▪TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE▪BHT▪ALUMINA▪POLYMETHYLSILSESQUIOXANE▪PHENOXYETHANOL▪TITANIUM DIOXIDE▪IRON OXIDES▪MICA▪
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 110 Alabaster
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 120 Ivory
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 130 Opal
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 140 Porcelain
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 150 Lace
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 160 Shell
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 210 Birch
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 220 Linen
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 230 Alder
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 240 Quartz
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 250 Sand
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 260 Cashmere
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 310 Silk
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 320 Pine
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 330 Bamboo
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 340 Oak
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 350 Maple
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 360 Citrine
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 410 Sunstone
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 420 Bronze
- 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
-
INGREDIENTS AND APPEARANCE
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 110
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-563 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.484 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.36 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) TANGERINE PEEL (UNII: JU3D414057) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) BARIUM SULFATE (UNII: 25BB7EKE2E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) 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:58411-563-10 1 in 1 CARTON 09/20/2020 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 09/20/2020 SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 120
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-564 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.484 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.36 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) TANGERINE PEEL (UNII: JU3D414057) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) BARIUM SULFATE (UNII: 25BB7EKE2E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) 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:58411-564-10 1 in 1 CARTON 09/20/2020 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 09/20/2020 SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 130
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-565 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.484 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.36 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) TANGERINE PEEL (UNII: JU3D414057) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) BARIUM SULFATE (UNII: 25BB7EKE2E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) 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:58411-565-10 1 in 1 CARTON 09/20/2020 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 09/20/2020 SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 140
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-566 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.484 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.36 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) TANGERINE PEEL (UNII: JU3D414057) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) BARIUM SULFATE (UNII: 25BB7EKE2E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) 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:58411-566-10 1 in 1 CARTON 09/20/2020 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 09/20/2020 SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 150
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-567 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.484 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.36 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) TANGERINE PEEL (UNII: JU3D414057) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) BARIUM SULFATE (UNII: 25BB7EKE2E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) 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:58411-567-10 1 in 1 CARTON 09/20/2020 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 09/20/2020 SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 160
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-568 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.484 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.36 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) TANGERINE PEEL (UNII: JU3D414057) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) BARIUM SULFATE (UNII: 25BB7EKE2E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) 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:58411-568-10 1 in 1 CARTON 09/20/2020 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 09/20/2020 SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 210
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-569 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.484 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.36 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) TANGERINE PEEL (UNII: JU3D414057) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) BARIUM SULFATE (UNII: 25BB7EKE2E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) 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:58411-569-10 1 in 1 CARTON 09/20/2020 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 09/20/2020 SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 220
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-570 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.484 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.36 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) TANGERINE PEEL (UNII: JU3D414057) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) BARIUM SULFATE (UNII: 25BB7EKE2E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) 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:58411-570-10 1 in 1 CARTON 09/20/2020 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 09/20/2020 SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 230
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-571 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.484 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.36 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) TANGERINE PEEL (UNII: JU3D414057) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) BARIUM SULFATE (UNII: 25BB7EKE2E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) 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:58411-571-10 1 in 1 CARTON 09/20/2020 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 09/20/2020 SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 240
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-572 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.484 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.36 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) TANGERINE PEEL (UNII: JU3D414057) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) BARIUM SULFATE (UNII: 25BB7EKE2E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) 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:58411-572-10 1 in 1 CARTON 09/20/2020 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 09/20/2020 SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 250
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-573 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.484 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.36 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) TANGERINE PEEL (UNII: JU3D414057) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) BARIUM SULFATE (UNII: 25BB7EKE2E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) 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:58411-573-10 1 in 1 CARTON 09/20/2020 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 09/20/2020 SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 260
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-574 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.484 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.36 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) TANGERINE PEEL (UNII: JU3D414057) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) BARIUM SULFATE (UNII: 25BB7EKE2E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) 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:58411-574-10 1 in 1 CARTON 09/20/2020 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 09/20/2020 SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 310
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-575 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.484 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.36 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) TANGERINE PEEL (UNII: JU3D414057) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) BARIUM SULFATE (UNII: 25BB7EKE2E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) 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:58411-575-10 1 in 1 CARTON 09/20/2020 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 09/20/2020 SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 320
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-576 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.484 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.36 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) TANGERINE PEEL (UNII: JU3D414057) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) BARIUM SULFATE (UNII: 25BB7EKE2E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) 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:58411-576-10 1 in 1 CARTON 09/20/2020 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 09/20/2020 SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 330
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-577 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.484 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.36 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) TANGERINE PEEL (UNII: JU3D414057) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) BARIUM SULFATE (UNII: 25BB7EKE2E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) 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:58411-577-10 1 in 1 CARTON 09/20/2020 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 09/20/2020 SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 340
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-578 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.484 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.36 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) TANGERINE PEEL (UNII: JU3D414057) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) BARIUM SULFATE (UNII: 25BB7EKE2E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) 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:58411-578-10 1 in 1 CARTON 09/20/2020 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 09/20/2020 SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 350
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-579 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.484 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.36 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) TANGERINE PEEL (UNII: JU3D414057) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) BARIUM SULFATE (UNII: 25BB7EKE2E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) 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:58411-579-10 1 in 1 CARTON 09/20/2020 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 09/20/2020 SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 360
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-580 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.484 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.36 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) TANGERINE PEEL (UNII: JU3D414057) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) BARIUM SULFATE (UNII: 25BB7EKE2E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) 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:58411-580-10 1 in 1 CARTON 09/20/2020 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 09/20/2020 SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 410
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-581 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.484 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.36 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) TANGERINE PEEL (UNII: JU3D414057) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) BARIUM SULFATE (UNII: 25BB7EKE2E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) 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:58411-581-10 1 in 1 CARTON 09/20/2020 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 09/20/2020 SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 420
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-582 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.484 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.36 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) TANGERINE PEEL (UNII: JU3D414057) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) BARIUM SULFATE (UNII: 25BB7EKE2E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) 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:58411-582-10 1 in 1 CARTON 09/20/2020 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 09/20/2020 SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 430
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-583 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.484 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.36 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) TANGERINE PEEL (UNII: JU3D414057) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) BARIUM SULFATE (UNII: 25BB7EKE2E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) 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:58411-583-10 1 in 1 CARTON 09/20/2020 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 09/20/2020 SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 440
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-584 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.484 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.36 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) TANGERINE PEEL (UNII: JU3D414057) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) BARIUM SULFATE (UNII: 25BB7EKE2E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) 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:58411-584-10 1 in 1 CARTON 09/20/2020 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 09/20/2020 SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 450
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-585 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.484 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.36 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) TANGERINE PEEL (UNII: JU3D414057) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) BARIUM SULFATE (UNII: 25BB7EKE2E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) 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:58411-585-10 1 in 1 CARTON 09/20/2020 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 09/20/2020 SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 460
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-586 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.484 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.36 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) TANGERINE PEEL (UNII: JU3D414057) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) BARIUM SULFATE (UNII: 25BB7EKE2E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) 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:58411-586-10 1 in 1 CARTON 09/20/2020 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 09/20/2020 SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 510
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-587 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.484 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.36 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) TANGERINE PEEL (UNII: JU3D414057) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) BARIUM SULFATE (UNII: 25BB7EKE2E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) 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:58411-587-10 1 in 1 CARTON 09/20/2020 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 09/20/2020 SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 520
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-588 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.484 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.36 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) TANGERINE PEEL (UNII: JU3D414057) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) BARIUM SULFATE (UNII: 25BB7EKE2E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) 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:58411-588-10 1 in 1 CARTON 09/20/2020 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 09/20/2020 SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 530
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-589 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.484 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.36 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) TANGERINE PEEL (UNII: JU3D414057) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) BARIUM SULFATE (UNII: 25BB7EKE2E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) 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:58411-589-10 1 in 1 CARTON 09/20/2020 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 09/20/2020 SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 540
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-590 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.484 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.36 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) TANGERINE PEEL (UNII: JU3D414057) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) BARIUM SULFATE (UNII: 25BB7EKE2E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) 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:58411-590-10 1 in 1 CARTON 09/20/2020 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 09/20/2020 SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 550
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-591 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.484 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.36 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) TANGERINE PEEL (UNII: JU3D414057) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) BARIUM SULFATE (UNII: 25BB7EKE2E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) 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:58411-591-10 1 in 1 CARTON 09/20/2020 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 09/20/2020 SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 560
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-592 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.484 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.36 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) TANGERINE PEEL (UNII: JU3D414057) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) BARIUM SULFATE (UNII: 25BB7EKE2E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) 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:58411-592-10 1 in 1 CARTON 09/20/2020 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 09/20/2020 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations Shiseido America Inc. 782677132 ANALYSIS(58411-563, 58411-564, 58411-565, 58411-566, 58411-567, 58411-568, 58411-569, 58411-570, 58411-571, 58411-572, 58411-573, 58411-574, 58411-575, 58411-576, 58411-577, 58411-578, 58411-579, 58411-580, 58411-581, 58411-582, 58411-583, 58411-584, 58411-585, 58411-586, 58411-587, 58411-588, 58411-589, 58411-590, 58411-591, 58411-592) , MANUFACTURE(58411-563, 58411-564, 58411-565, 58411-566, 58411-567, 58411-568, 58411-569, 58411-570, 58411-571, 58411-572, 58411-573, 58411-574, 58411-575, 58411-576, 58411-577, 58411-578, 58411-579, 58411-580, 58411-581, 58411-582, 58411-583, 58411-584, 58411-585, 58411-586, 58411-587, 58411-588, 58411-589, 58411-590, 58411-591, 58411-592)