Label: SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 110- octinoxate emulsion
SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 120- octinoxate emulsion
SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 130- octinoxate emulsion
SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 140- octinoxate emulsion
SHISEIDO REVITALESSENCE SKIN GLOW FOUND .......OUNDATION 520- octinoxate emulsion
SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 530- octinoxate emulsion
SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 540- octinoxate emulsion
SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 550- octinoxate emulsion
SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 560- octinoxate emulsion
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NDC Code(s):
58411-859-40,
58411-860-40,
58411-861-40,
58411-862-40, view more58411-863-40, 58411-864-40, 58411-865-40, 58411-866-40, 58411-867-40, 58411-868-40, 58411-869-40, 58411-870-40, 58411-871-40, 58411-872-40, 58411-873-40, 58411-874-40, 58411-875-40, 58411-876-40, 58411-877-40, 58411-878-40, 58411-879-40, 58411-880-40, 58411-881-40, 58411-882-40, 58411-883-40, 58411-884-40, 58411-885-40, 58411-886-40, 58411-887-40, 58411-895-40
- Packager: SHISEIDO AMERICAS CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 13, 2025
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 ingredients
- Purpose
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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
-
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
- children under 6 months: Ask a doctor
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Inactive Ingredients
WATER･DIPHENYLSILOXY PHENYL TRIMETHICONE･DIPROPYLENE GLYCOL･GLYCERIN･NIACINAMIDE･ALCOHOL DENAT.･PEG-8･PEG-60 HYDROGENATED CASTOR OIL･LACTOBACILLUS/RICE FERMENT･AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER･TOCOPHERYL ACETATE･SODIUM DILAURAMIDOGLUTAMIDE LYSINE･MAGNESIUM CHLORIDE･POLYQUATERNIUM-51･LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL･SANGUISORBA OFFICINALIS ROOT EXTRACT･CAMELLIA SINENSIS LEAF EXTRACT･HYDROGENATED POLYISOBUTENE･PEG-12 DIMETHICONE･ISOSTEARIC ACID･POLYGLYCERYL-6 POLYRICINOLEATE･PEG-100 HYDROGENATED CASTOR OIL･BUTYLENE GLYCOL･ALUMINUM HYDROXIDE･DIMETHYLACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE CROSSPOLYMER･ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER･TRISODIUM EDTA･BHT･TOCOPHEROL･POTASSIUM HYDROXIDE･ALCOHOL･SODIUM METABISULFITE･PEG/PPG-19/19 DIMETHICONE･STEARIC ACID･PHENOXYETHANOL･TITANIUM DIOXIDE･IRON OXIDES･
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 110
- PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 120
- PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 130
- PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 140
- PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 150
- PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 160
- PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 210
- PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 220
- PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 230
- PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 240
- PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 250
- PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 260
- PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 310
- PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 320
- PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 330
- PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 340
- PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 350
- PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 360
- PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 410
- PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 420
- PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 430
- PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 440
- PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 450
- PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 460
- PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 510
- PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 520
- PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 530
- PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 540
- PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 550
- PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 560
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INGREDIENTS AND APPEARANCE
SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 110
octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-859 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.30805 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) NIACINAMIDE (UNII: 25X51I8RD4) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) ISOSTEARIC ACID (UNII: X33R8U0062) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) SODIUM METABISULFITE (UNII: 4VON5FNS3C) LAVENDER OIL (UNII: ZBP1YXW0H8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-859-40 1 in 1 CARTON 08/01/2023 1 30 mL in 1 CONTAINER; 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 08/01/2023 SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 120
octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-860 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.30805 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) NIACINAMIDE (UNII: 25X51I8RD4) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) ISOSTEARIC ACID (UNII: X33R8U0062) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) SODIUM METABISULFITE (UNII: 4VON5FNS3C) LAVENDER OIL (UNII: ZBP1YXW0H8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-860-40 1 in 1 CARTON 08/01/2023 1 30 mL in 1 CONTAINER; 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 08/01/2023 SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 130
octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-861 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.30805 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) NIACINAMIDE (UNII: 25X51I8RD4) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) ISOSTEARIC ACID (UNII: X33R8U0062) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) SODIUM METABISULFITE (UNII: 4VON5FNS3C) LAVENDER OIL (UNII: ZBP1YXW0H8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-861-40 1 in 1 CARTON 08/01/2023 1 30 mL in 1 CONTAINER; 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 08/01/2023 SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 140
octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-862 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.30805 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) NIACINAMIDE (UNII: 25X51I8RD4) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) ISOSTEARIC ACID (UNII: X33R8U0062) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) SODIUM METABISULFITE (UNII: 4VON5FNS3C) LAVENDER OIL (UNII: ZBP1YXW0H8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-862-40 1 in 1 CARTON 08/01/2023 1 30 mL in 1 CONTAINER; 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 08/01/2023 SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 150
octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-863 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.30805 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) NIACINAMIDE (UNII: 25X51I8RD4) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) ISOSTEARIC ACID (UNII: X33R8U0062) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) SODIUM METABISULFITE (UNII: 4VON5FNS3C) LAVENDER OIL (UNII: ZBP1YXW0H8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-863-40 1 in 1 CARTON 08/01/2023 1 30 mL in 1 CONTAINER; 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 08/01/2023 SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 160
octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-864 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.30805 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) NIACINAMIDE (UNII: 25X51I8RD4) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) ISOSTEARIC ACID (UNII: X33R8U0062) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) SODIUM METABISULFITE (UNII: 4VON5FNS3C) LAVENDER OIL (UNII: ZBP1YXW0H8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-864-40 1 in 1 CARTON 08/01/2023 1 30 mL in 1 CONTAINER; 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 08/01/2023 SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 210
octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-865 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.30805 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) NIACINAMIDE (UNII: 25X51I8RD4) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) ISOSTEARIC ACID (UNII: X33R8U0062) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) SODIUM METABISULFITE (UNII: 4VON5FNS3C) LAVENDER OIL (UNII: ZBP1YXW0H8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-865-40 1 in 1 CARTON 08/01/2023 1 30 mL in 1 CONTAINER; 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 08/01/2023 SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 220
octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-866 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.30805 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) NIACINAMIDE (UNII: 25X51I8RD4) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) ISOSTEARIC ACID (UNII: X33R8U0062) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) SODIUM METABISULFITE (UNII: 4VON5FNS3C) LAVENDER OIL (UNII: ZBP1YXW0H8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-866-40 1 in 1 CARTON 08/01/2023 1 30 mL in 1 CONTAINER; 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 08/01/2023 SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 230
octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-867 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.30805 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) NIACINAMIDE (UNII: 25X51I8RD4) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) ISOSTEARIC ACID (UNII: X33R8U0062) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) SODIUM METABISULFITE (UNII: 4VON5FNS3C) LAVENDER OIL (UNII: ZBP1YXW0H8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-867-40 1 in 1 CARTON 08/01/2023 1 30 mL in 1 CONTAINER; 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 08/01/2023 SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 240
octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-868 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.30805 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) NIACINAMIDE (UNII: 25X51I8RD4) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) ISOSTEARIC ACID (UNII: X33R8U0062) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) SODIUM METABISULFITE (UNII: 4VON5FNS3C) LAVENDER OIL (UNII: ZBP1YXW0H8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-868-40 1 in 1 CARTON 08/01/2023 1 30 mL in 1 CONTAINER; 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 08/01/2023 SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 250
octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-869 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.30805 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) NIACINAMIDE (UNII: 25X51I8RD4) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) ISOSTEARIC ACID (UNII: X33R8U0062) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) SODIUM METABISULFITE (UNII: 4VON5FNS3C) LAVENDER OIL (UNII: ZBP1YXW0H8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-869-40 1 in 1 CARTON 08/01/2023 1 30 mL in 1 CONTAINER; 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 08/01/2023 SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 260
octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-870 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.30805 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) NIACINAMIDE (UNII: 25X51I8RD4) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) ISOSTEARIC ACID (UNII: X33R8U0062) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) SODIUM METABISULFITE (UNII: 4VON5FNS3C) LAVENDER OIL (UNII: ZBP1YXW0H8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-870-40 1 in 1 CARTON 08/01/2023 1 30 mL in 1 CONTAINER; 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 08/01/2023 SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 310
octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-871 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.30805 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) NIACINAMIDE (UNII: 25X51I8RD4) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) ISOSTEARIC ACID (UNII: X33R8U0062) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) SODIUM METABISULFITE (UNII: 4VON5FNS3C) LAVENDER OIL (UNII: ZBP1YXW0H8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-871-40 1 in 1 CARTON 08/01/2023 1 30 mL in 1 CONTAINER; 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 08/01/2023 SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 320
octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-872 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.30805 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) NIACINAMIDE (UNII: 25X51I8RD4) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) ISOSTEARIC ACID (UNII: X33R8U0062) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) SODIUM METABISULFITE (UNII: 4VON5FNS3C) LAVENDER OIL (UNII: ZBP1YXW0H8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-872-40 1 in 1 CARTON 08/01/2023 1 30 mL in 1 CONTAINER; 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 08/01/2023 SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 330
octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-873 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.30805 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) NIACINAMIDE (UNII: 25X51I8RD4) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) ISOSTEARIC ACID (UNII: X33R8U0062) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) SODIUM METABISULFITE (UNII: 4VON5FNS3C) LAVENDER OIL (UNII: ZBP1YXW0H8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-873-40 1 in 1 CARTON 08/01/2023 1 30 mL in 1 CONTAINER; 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 08/01/2023 SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 340
octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-874 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.30805 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) NIACINAMIDE (UNII: 25X51I8RD4) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) ISOSTEARIC ACID (UNII: X33R8U0062) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) SODIUM METABISULFITE (UNII: 4VON5FNS3C) LAVENDER OIL (UNII: ZBP1YXW0H8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-874-40 1 in 1 CARTON 08/01/2023 1 30 mL in 1 CONTAINER; 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 08/01/2023 SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 350
octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-875 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.30805 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) NIACINAMIDE (UNII: 25X51I8RD4) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) ISOSTEARIC ACID (UNII: X33R8U0062) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) SODIUM METABISULFITE (UNII: 4VON5FNS3C) LAVENDER OIL (UNII: ZBP1YXW0H8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-875-40 1 in 1 CARTON 08/01/2023 1 30 mL in 1 CONTAINER; 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 08/01/2023 SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 360
octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-876 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.30805 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) NIACINAMIDE (UNII: 25X51I8RD4) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) ISOSTEARIC ACID (UNII: X33R8U0062) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) SODIUM METABISULFITE (UNII: 4VON5FNS3C) LAVENDER OIL (UNII: ZBP1YXW0H8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-876-40 1 in 1 CARTON 08/01/2023 1 30 mL in 1 CONTAINER; 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 08/01/2023 SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 410
octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-877 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.30805 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) NIACINAMIDE (UNII: 25X51I8RD4) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) ISOSTEARIC ACID (UNII: X33R8U0062) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) SODIUM METABISULFITE (UNII: 4VON5FNS3C) LAVENDER OIL (UNII: ZBP1YXW0H8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-877-40 1 in 1 CARTON 08/01/2023 1 30 mL in 1 CONTAINER; 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 08/01/2023 SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 420
octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-878 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.30805 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) NIACINAMIDE (UNII: 25X51I8RD4) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) ISOSTEARIC ACID (UNII: X33R8U0062) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) SODIUM METABISULFITE (UNII: 4VON5FNS3C) LAVENDER OIL (UNII: ZBP1YXW0H8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-878-40 1 in 1 CARTON 08/01/2023 1 30 mL in 1 CONTAINER; 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 08/01/2023 SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 430
octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-879 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.30805 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) NIACINAMIDE (UNII: 25X51I8RD4) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) ISOSTEARIC ACID (UNII: X33R8U0062) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) SODIUM METABISULFITE (UNII: 4VON5FNS3C) LAVENDER OIL (UNII: ZBP1YXW0H8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-879-40 1 in 1 CARTON 08/01/2023 1 30 mL in 1 CONTAINER; 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 08/01/2023 SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 440
octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-880 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.30805 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) NIACINAMIDE (UNII: 25X51I8RD4) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) ISOSTEARIC ACID (UNII: X33R8U0062) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) SODIUM METABISULFITE (UNII: 4VON5FNS3C) LAVENDER OIL (UNII: ZBP1YXW0H8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-880-40 1 in 1 CARTON 08/01/2023 1 30 mL in 1 CONTAINER; 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 08/01/2023 SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 450
octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-881 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.30805 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) NIACINAMIDE (UNII: 25X51I8RD4) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) ISOSTEARIC ACID (UNII: X33R8U0062) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) SODIUM METABISULFITE (UNII: 4VON5FNS3C) LAVENDER OIL (UNII: ZBP1YXW0H8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-881-40 1 in 1 CARTON 08/01/2023 1 30 mL in 1 CONTAINER; 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 08/01/2023 SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 460
octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-882 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.30805 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) NIACINAMIDE (UNII: 25X51I8RD4) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) ISOSTEARIC ACID (UNII: X33R8U0062) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) SODIUM METABISULFITE (UNII: 4VON5FNS3C) LAVENDER OIL (UNII: ZBP1YXW0H8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-882-40 1 in 1 CARTON 08/01/2023 1 30 mL in 1 CONTAINER; 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 08/01/2023 SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 510
octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-883 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.30805 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) NIACINAMIDE (UNII: 25X51I8RD4) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) ISOSTEARIC ACID (UNII: X33R8U0062) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) SODIUM METABISULFITE (UNII: 4VON5FNS3C) LAVENDER OIL (UNII: ZBP1YXW0H8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-883-40 1 in 1 CARTON 08/01/2023 1 30 mL in 1 CONTAINER; 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 08/01/2023 SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 520
octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-884 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.30805 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) NIACINAMIDE (UNII: 25X51I8RD4) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) ISOSTEARIC ACID (UNII: X33R8U0062) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) SODIUM METABISULFITE (UNII: 4VON5FNS3C) LAVENDER OIL (UNII: ZBP1YXW0H8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-884-40 1 in 1 CARTON 08/01/2023 1 30 mL in 1 CONTAINER; 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 08/01/2023 SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 530
octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-885 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.30805 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) NIACINAMIDE (UNII: 25X51I8RD4) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) ISOSTEARIC ACID (UNII: X33R8U0062) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) SODIUM METABISULFITE (UNII: 4VON5FNS3C) LAVENDER OIL (UNII: ZBP1YXW0H8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-885-40 1 in 1 CARTON 08/01/2023 1 30 mL in 1 CONTAINER; 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 08/01/2023 SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 540
octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-886 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.30805 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) NIACINAMIDE (UNII: 25X51I8RD4) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) ISOSTEARIC ACID (UNII: X33R8U0062) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) SODIUM METABISULFITE (UNII: 4VON5FNS3C) LAVENDER OIL (UNII: ZBP1YXW0H8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-886-40 1 in 1 CARTON 08/01/2023 1 30 mL in 1 CONTAINER; 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 08/01/2023 SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 550
octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-887 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.30805 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) NIACINAMIDE (UNII: 25X51I8RD4) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) ISOSTEARIC ACID (UNII: X33R8U0062) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) SODIUM METABISULFITE (UNII: 4VON5FNS3C) LAVENDER OIL (UNII: ZBP1YXW0H8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-887-40 1 in 1 CARTON 08/01/2023 1 30 mL in 1 CONTAINER; 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 08/01/2023 SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 560
octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-895 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.30805 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) NIACINAMIDE (UNII: 25X51I8RD4) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) ISOSTEARIC ACID (UNII: X33R8U0062) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) SODIUM METABISULFITE (UNII: 4VON5FNS3C) LAVENDER OIL (UNII: ZBP1YXW0H8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-895-40 1 in 1 CARTON 08/01/2023 1 30 mL in 1 CONTAINER; 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 08/01/2023 Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
