Drug Facts

Active ingredients

OCTINOXATE 6.9%

Purpose

Sunscreen

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

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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

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

protect this product in this container from excessive heat and direct sun.

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 110

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GINZA TOKYO

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BROAD SPECTRUM
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SPF30

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SPF30

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BROAD SPECTRUM
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Niacinamide

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Principal Display Panel - 30 mL Container Carton - 540

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SHISEIDO
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Niacinamide

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Principal Display Panel - 30 mL Container Carton - 550

SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 110
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-859
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.30805 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	08/01/2023

SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 120
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-860
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.30805 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	08/01/2023

SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 130
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-861
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.30805 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	08/01/2023

SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 140
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-862
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.30805 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	08/01/2023

SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 150
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-863
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.30805 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	08/01/2023

SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 160
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-864
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.30805 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	08/01/2023

SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 210
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-865
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.30805 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	08/01/2023

SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 220
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-866
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.30805 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	08/01/2023

SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 230
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-867
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.30805 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	08/01/2023

SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 240
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-868
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.30805 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	08/01/2023

SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 250
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-869
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.30805 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	08/01/2023

SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 260
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-870
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.30805 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	08/01/2023

SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 310
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-871
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.30805 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	08/01/2023

SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 320
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-872
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.30805 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	08/01/2023

SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 330
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-873
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.30805 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	08/01/2023

SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 340
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-874
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.30805 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	08/01/2023

SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 350
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-875
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.30805 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	08/01/2023

SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 360
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-876
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.30805 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	08/01/2023

SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 410
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-877
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.30805 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	08/01/2023

SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 420
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-878
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.30805 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	08/01/2023

SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 430
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-879
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.30805 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	08/01/2023

SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 440
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-880
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.30805 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	08/01/2023

SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 450
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-881
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.30805 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	08/01/2023

SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 460
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-882
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.30805 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	08/01/2023

SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 510
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-883
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.30805 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	08/01/2023

SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 520
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-884
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.30805 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	08/01/2023

SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 530
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-885
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.30805 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	08/01/2023

SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 540
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-886
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.30805 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	08/01/2023

SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 550
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-887
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.30805 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	08/01/2023

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)