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 510- octinoxate emulsion SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 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 by

Drug Labeling and Warnings

SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

SHISEIDO
GINZA TOKYO

REVITALESSENCE
SKIN GLOW

Foundation

BROAD SPECTRUM
SPF30

Sunscreen

Bio-BoostRED Technology
Fermented Kefir+
Niacinamide

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 120

SHISEIDO
GINZA TOKYO

REVITALESSENCE
SKIN GLOW

Foundation

BROAD SPECTRUM
SPF30

Sunscreen

Bio-BoostRED Technology
Fermented Kefir+
Niacinamide

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 130

SHISEIDO
GINZA TOKYO

REVITALESSENCE
SKIN GLOW

Foundation

BROAD SPECTRUM
SPF30

Sunscreen

Bio-BoostRED Technology
Fermented Kefir+
Niacinamide

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 140

SHISEIDO
GINZA TOKYO

REVITALESSENCE
SKIN GLOW

Foundation

BROAD SPECTRUM
SPF30

Sunscreen

Bio-BoostRED Technology
Fermented Kefir+
Niacinamide

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 150

SHISEIDO
GINZA TOKYO

REVITALESSENCE
SKIN GLOW

Foundation

BROAD SPECTRUM
SPF30

Sunscreen

Bio-BoostRED Technology
Fermented Kefir+
Niacinamide

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 160

SHISEIDO
GINZA TOKYO

REVITALESSENCE
SKIN GLOW

Foundation

BROAD SPECTRUM
SPF30

Sunscreen

Bio-BoostRED Technology
Fermented Kefir+
Niacinamide

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 210

SHISEIDO
GINZA TOKYO

REVITALESSENCE
SKIN GLOW

Foundation

BROAD SPECTRUM
SPF30

Sunscreen

Bio-BoostRED Technology
Fermented Kefir+
Niacinamide

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 220

SHISEIDO
GINZA TOKYO

REVITALESSENCE
SKIN GLOW

Foundation

BROAD SPECTRUM
SPF30

Sunscreen

Bio-BoostRED Technology
Fermented Kefir+
Niacinamide

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 230

SHISEIDO
GINZA TOKYO

REVITALESSENCE
SKIN GLOW

Foundation

BROAD SPECTRUM
SPF30

Sunscreen

Bio-BoostRED Technology
Fermented Kefir+
Niacinamide

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 240

SHISEIDO
GINZA TOKYO

REVITALESSENCE
SKIN GLOW

Foundation

BROAD SPECTRUM
SPF30

Sunscreen

Bio-BoostRED Technology
Fermented Kefir+
Niacinamide

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 250

SHISEIDO
GINZA TOKYO

REVITALESSENCE
SKIN GLOW

Foundation

BROAD SPECTRUM
SPF30

Sunscreen

Bio-BoostRED Technology
Fermented Kefir+
Niacinamide

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 260

SHISEIDO
GINZA TOKYO

REVITALESSENCE
SKIN GLOW

Foundation

BROAD SPECTRUM
SPF30

Sunscreen

Bio-BoostRED Technology
Fermented Kefir+
Niacinamide

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 310

SHISEIDO
GINZA TOKYO

REVITALESSENCE
SKIN GLOW

Foundation

BROAD SPECTRUM
SPF30

Sunscreen

Bio-BoostRED Technology
Fermented Kefir+
Niacinamide

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 320

SHISEIDO
GINZA TOKYO

REVITALESSENCE
SKIN GLOW

Foundation

BROAD SPECTRUM
SPF30

Sunscreen

Bio-BoostRED Technology
Fermented Kefir+
Niacinamide

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 330

SHISEIDO
GINZA TOKYO

REVITALESSENCE
SKIN GLOW

Foundation

BROAD SPECTRUM
SPF30

Sunscreen

Bio-BoostRED Technology
Fermented Kefir+
Niacinamide

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 340

SHISEIDO
GINZA TOKYO

REVITALESSENCE
SKIN GLOW

Foundation

BROAD SPECTRUM
SPF30

Sunscreen

Bio-BoostRED Technology
Fermented Kefir+
Niacinamide

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 350

SHISEIDO
GINZA TOKYO

REVITALESSENCE
SKIN GLOW

Foundation

BROAD SPECTRUM
SPF30

Sunscreen

Bio-BoostRED Technology
Fermented Kefir+
Niacinamide

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 360

SHISEIDO
GINZA TOKYO

REVITALESSENCE
SKIN GLOW

Foundation

BROAD SPECTRUM
SPF30

Sunscreen

Bio-BoostRED Technology
Fermented Kefir+
Niacinamide

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 410

SHISEIDO
GINZA TOKYO

REVITALESSENCE
SKIN GLOW

Foundation

BROAD SPECTRUM
SPF30

Sunscreen

Bio-BoostRED Technology
Fermented Kefir+
Niacinamide

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 420

SHISEIDO
GINZA TOKYO

REVITALESSENCE
SKIN GLOW

Foundation

BROAD SPECTRUM
SPF30

Sunscreen

Bio-BoostRED Technology
Fermented Kefir+
Niacinamide

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 430

SHISEIDO
GINZA TOKYO

REVITALESSENCE
SKIN GLOW

Foundation

BROAD SPECTRUM
SPF30

Sunscreen

Bio-BoostRED Technology
Fermented Kefir+
Niacinamide

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 440

SHISEIDO
GINZA TOKYO

REVITALESSENCE
SKIN GLOW

Foundation

BROAD SPECTRUM
SPF30

Sunscreen

Bio-BoostRED Technology
Fermented Kefir+
Niacinamide

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 450

SHISEIDO
GINZA TOKYO

REVITALESSENCE
SKIN GLOW

Foundation

BROAD SPECTRUM
SPF30

Sunscreen

Bio-BoostRED Technology
Fermented Kefir+
Niacinamide

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 460

SHISEIDO
GINZA TOKYO

REVITALESSENCE
SKIN GLOW

Foundation

BROAD SPECTRUM
SPF30

Sunscreen

Bio-BoostRED Technology
Fermented Kefir+
Niacinamide

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 510

SHISEIDO
GINZA TOKYO

REVITALESSENCE
SKIN GLOW

Foundation

BROAD SPECTRUM
SPF30

Sunscreen

Bio-BoostRED Technology
Fermented Kefir+
Niacinamide

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 520

SHISEIDO
GINZA TOKYO

REVITALESSENCE
SKIN GLOW

Foundation

BROAD SPECTRUM
SPF30

Sunscreen

Bio-BoostRED Technology
Fermented Kefir+
Niacinamide

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 530

SHISEIDO
GINZA TOKYO

REVITALESSENCE
SKIN GLOW

Foundation

BROAD SPECTRUM
SPF30

Sunscreen

Bio-BoostRED Technology
Fermented Kefir+
Niacinamide

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 540

SHISEIDO
GINZA TOKYO

REVITALESSENCE
SKIN GLOW

Foundation

BROAD SPECTRUM
SPF30

Sunscreen

Bio-BoostRED Technology
Fermented Kefir+
Niacinamide

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - 550

SHISEIDO
GINZA TOKYO

REVITALESSENCE
SKIN GLOW

Foundation

BROAD SPECTRUM
SPF30

Sunscreen

Bio-BoostRED Technology
Fermented Kefir+
Niacinamide

30mL 1FL. OZ.

INGREDIENTS AND APPEARANCE

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

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 POLYBUTENE (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 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

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 POLYBUTENE (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 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

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 POLYBUTENE (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 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

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 POLYBUTENE (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 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

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 POLYBUTENE (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 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

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 POLYBUTENE (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 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

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 POLYBUTENE (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 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

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 POLYBUTENE (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 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

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 POLYBUTENE (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 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

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 POLYBUTENE (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 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

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 POLYBUTENE (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 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

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 POLYBUTENE (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 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

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 POLYBUTENE (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 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

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 POLYBUTENE (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 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

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 POLYBUTENE (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 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

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 POLYBUTENE (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 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

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 POLYBUTENE (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 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

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 POLYBUTENE (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 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

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 POLYBUTENE (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 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

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 POLYBUTENE (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 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

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 POLYBUTENE (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 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

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 POLYBUTENE (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 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

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 POLYBUTENE (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 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

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 POLYBUTENE (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 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

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 POLYBUTENE (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 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

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 POLYBUTENE (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 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

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 POLYBUTENE (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 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

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 POLYBUTENE (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 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

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 POLYBUTENE (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 NOT FINAL	part352	08/01/2023

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)