CLE DE PEAU BEAUTE THE FOUNDATION N O50 TAN OCHER- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE THE FOUNDATION N I10 VERY LIGHT IVORY- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE THE FOUNDATION N O10 LIGHT OCHER- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE THE FOUNDATION N O20 LIGHT MEDIUM OCHER- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE THE FOUNDATION N O30 MEDIUM OCHER- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE THE FOUNDATION N O40 LIGHT TAN OCHER- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE THE FOUNDATION N O60 DEEP TAN OCHER- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE THE FOUNDATION N O80 DEEP OCHER- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE THE FOUNDATION N O100 RICH DEEP OCHER- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE THE FOUNDATION N B10 LIGHT BEIGE- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE THE FOUNDATION N B20 LIGHT MEDIUM BEIGE- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE THE FOUNDATION N B30 MEDIUM BEIGE- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE THE FOUNDATION N B40 LIGHT TAN BEIGE- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE THE FOUNDATION N B50 TAN BEIGE- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE THE FOUNDATION N BF10 LIGHT BUFF- octinoxate and titanium dioxide emulsion

cle de peau BEAUTE THE FOUNDATION N by

Drug Labeling and Warnings

cle de peau BEAUTE THE FOUNDATION N 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 INGREDIENT

Active ingredients	Purpose
Octinoxate 3.9%	Sunscreen
Titanium Dioxide 3.3%	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 value 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▪DIMETHICONE▪BUTYLENE GLYCOL▪GLYCERIN▪CETYL ETHYLHEXANOATE▪CETYL PEG/PPG-10/1 DIMETHICONE▪NEOPENTYL GLYCOL DIHEPTANOATE▪DIPHENYLSILOXY PHENYL TRIMETHICONE▪TREHALOSE▪TOCOPHERYL ACETATE▪ARGANIA SPINOSA KERNEL OIL▪SODIUM HYALURONATE▪SODIUM DILAURAMIDOGLUTAMIDE LYSINE▪MAGNESIUM CHLORIDE▪PISTACIA LENTISCUS (MASTIC) GUM▪GLYCINE▪PEG/PPG-14/7 DIMETHYL ETHER▪BUPLEURUM FALCATUM ROOT EXTRACT▪ZANTHOXYLUM PIPERITUM PEEL EXTRACT▪THYMUS SERPYLLUM EXTRACT▪SODIUM ACETYLATED HYALURONATE▪ROSA ROXBURGHII FRUIT EXTRACT▪ANGELICA ACUTILOBA ROOT EXTRACT▪HYDROLYZED CONCHIOLIN PROTEIN▪HYDROLYZED SILK▪PERILLA OCYMOIDES LEAF EXTRACT▪DEXTRIN PALMITATE▪PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE▪ALUMINUM HYDROXIDE▪STEARIC ACID▪TRISODIUM EDTA▪HYDROXYPROPYLCELLULOSE▪PALMITIC ACID▪DIMETHYLACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE CROSSPOLYMER▪ALCOHOL▪DISTEARYLDIMONIUM CHLORIDE▪TRIETHOXYCAPRYLYLSILANE▪SYNTHETIC FLUORPHLOGOPITE▪BARIUM SULFATE▪CAPRYLIC/CAPRIC TRIGLYCERIDE▪ISOPROPYL ALCOHOL▪BHT▪SILICA▪THEANINE▪PHENOXYETHANOL▪CHLOROPHENESIN▪FRAGRANCE▪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 - 28 mL Bottle Box - O50 Tan Ocher

clé de peau

B E A U T É

THE FOUNDATION N

BROAD SPECTRUM
SPF 22
SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - I10 Very Light Ivory

clé de peau

B E A U T É

THE FOUNDATION N

BROAD SPECTRUM
SPF 22
SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - O10 Light Ocher

clé de peau

B E A U T É

THE FOUNDATION N

BROAD SPECTRUM
SPF 22
SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - O20 Light Medium Ocher

clé de peau

B E A U T É

THE FOUNDATION N

BROAD SPECTRUM
SPF 22
SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - O30 Medium Ocher

clé de peau

B E A U T É

THE FOUNDATION N

BROAD SPECTRUM
SPF 22
SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - O40 Light Tan Ocher

clé de peau

B E A U T É

THE FOUNDATION N

BROAD SPECTRUM
SPF 22
SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - O60 Deep Tan Ocher

clé de peau

B E A U T É

THE FOUNDATION N

BROAD SPECTRUM
SPF 22
SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - O80 Deep Ocher

clé de peau

B E A U T É

THE FOUNDATION N

BROAD SPECTRUM
SPF 22
SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - O100 Rich Deep Ocher

clé de peau

B E A U T É

THE FOUNDATION N

BROAD SPECTRUM
SPF 22
SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - B10 Light Beige

clé de peau

B E A U T É

THE FOUNDATION N

BROAD SPECTRUM
SPF 22
SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - B20 Light Medium Beige

clé de peau

B E A U T É

THE FOUNDATION N

BROAD SPECTRUM
SPF 22
SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - B30 Medium Beige

clé de peau

B E A U T É

THE FOUNDATION N

BROAD SPECTRUM
SPF 22
SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - B40 Light Tan Beige

clé de peau

B E A U T É

THE FOUNDATION N

BROAD SPECTRUM
SPF 22
SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - B50 Tan Beige

clé de peau

B E A U T É

THE FOUNDATION N

BROAD SPECTRUM
SPF 22
SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - BF10 Light Buff

clé de peau

B E A U T É

THE FOUNDATION N

BROAD SPECTRUM
SPF 22
SUNSCREEN

28mL NET WT. 1 OZ.

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE THE FOUNDATION N   O50 TAN OCHER
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-839
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1092 mg  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	924 mg  in 28 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE TRISODIUM (UNII: 420IP921MB)
ARGAN OIL (UNII: 4V59G5UW9X)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
PALMITIC ACID (UNII: 2V16EO95H1)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TREHALOSE (UNII: B8WCK70T7I)
ALCOHOL (UNII: 3K9958V90M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PISTACIA LENTISCUS RESIN (UNII: 7446H202QW)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-839-50	1 in 1 BOX	04/01/2022
1		28 mL in 1 BOTTLE, GLASS; 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	04/01/2022

CLE DE PEAU BEAUTE THE FOUNDATION N   I10 VERY LIGHT IVORY
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-840
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1092 mg  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	924 mg  in 28 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE TRISODIUM (UNII: 420IP921MB)
ARGAN OIL (UNII: 4V59G5UW9X)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
PALMITIC ACID (UNII: 2V16EO95H1)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TREHALOSE (UNII: B8WCK70T7I)
ALCOHOL (UNII: 3K9958V90M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PISTACIA LENTISCUS RESIN (UNII: 7446H202QW)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-840-50	1 in 1 BOX	04/01/2022
1		28 mL in 1 BOTTLE, GLASS; 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	04/01/2022

CLE DE PEAU BEAUTE THE FOUNDATION N   O10 LIGHT OCHER
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-841
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1092 mg  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	924 mg  in 28 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE TRISODIUM (UNII: 420IP921MB)
ARGAN OIL (UNII: 4V59G5UW9X)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
PALMITIC ACID (UNII: 2V16EO95H1)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TREHALOSE (UNII: B8WCK70T7I)
ALCOHOL (UNII: 3K9958V90M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PISTACIA LENTISCUS RESIN (UNII: 7446H202QW)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-841-50	1 in 1 BOX	04/01/2022
1		28 mL in 1 BOTTLE, GLASS; 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	04/01/2022

CLE DE PEAU BEAUTE THE FOUNDATION N   O20 LIGHT MEDIUM OCHER
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-842
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1092 mg  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	924 mg  in 28 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE TRISODIUM (UNII: 420IP921MB)
ARGAN OIL (UNII: 4V59G5UW9X)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
PALMITIC ACID (UNII: 2V16EO95H1)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TREHALOSE (UNII: B8WCK70T7I)
ALCOHOL (UNII: 3K9958V90M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PISTACIA LENTISCUS RESIN (UNII: 7446H202QW)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-842-50	1 in 1 BOX	04/01/2022
1		28 mL in 1 BOTTLE, GLASS; 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	04/01/2022

CLE DE PEAU BEAUTE THE FOUNDATION N   O30 MEDIUM OCHER
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-843
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1092 mg  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	924 mg  in 28 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE TRISODIUM (UNII: 420IP921MB)
ARGAN OIL (UNII: 4V59G5UW9X)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
PALMITIC ACID (UNII: 2V16EO95H1)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TREHALOSE (UNII: B8WCK70T7I)
ALCOHOL (UNII: 3K9958V90M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PISTACIA LENTISCUS RESIN (UNII: 7446H202QW)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-843-50	1 in 1 BOX	04/01/2022
1		28 mL in 1 BOTTLE, GLASS; 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	04/01/2022

CLE DE PEAU BEAUTE THE FOUNDATION N   O40 LIGHT TAN OCHER
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-844
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1092 mg  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	924 mg  in 28 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE TRISODIUM (UNII: 420IP921MB)
ARGAN OIL (UNII: 4V59G5UW9X)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
PALMITIC ACID (UNII: 2V16EO95H1)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TREHALOSE (UNII: B8WCK70T7I)
ALCOHOL (UNII: 3K9958V90M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PISTACIA LENTISCUS RESIN (UNII: 7446H202QW)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-844-50	1 in 1 BOX	04/01/2022
1		28 mL in 1 BOTTLE, GLASS; 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	04/01/2022

CLE DE PEAU BEAUTE THE FOUNDATION N   O60 DEEP TAN OCHER
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-845
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1092 mg  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	924 mg  in 28 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE TRISODIUM (UNII: 420IP921MB)
ARGAN OIL (UNII: 4V59G5UW9X)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
PALMITIC ACID (UNII: 2V16EO95H1)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TREHALOSE (UNII: B8WCK70T7I)
ALCOHOL (UNII: 3K9958V90M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PISTACIA LENTISCUS RESIN (UNII: 7446H202QW)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-845-50	1 in 1 BOX	04/01/2022
1		28 mL in 1 BOTTLE, GLASS; 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	04/01/2022

CLE DE PEAU BEAUTE THE FOUNDATION N   O80 DEEP OCHER
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-846
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1092 mg  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	924 mg  in 28 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE TRISODIUM (UNII: 420IP921MB)
ARGAN OIL (UNII: 4V59G5UW9X)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
PALMITIC ACID (UNII: 2V16EO95H1)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TREHALOSE (UNII: B8WCK70T7I)
ALCOHOL (UNII: 3K9958V90M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PISTACIA LENTISCUS RESIN (UNII: 7446H202QW)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-846-50	1 in 1 BOX	04/01/2022
1		28 mL in 1 BOTTLE, GLASS; 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	04/01/2022

CLE DE PEAU BEAUTE THE FOUNDATION N   O100 RICH DEEP OCHER
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-847
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1092 mg  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	924 mg  in 28 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE TRISODIUM (UNII: 420IP921MB)
ARGAN OIL (UNII: 4V59G5UW9X)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
PALMITIC ACID (UNII: 2V16EO95H1)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TREHALOSE (UNII: B8WCK70T7I)
ALCOHOL (UNII: 3K9958V90M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PISTACIA LENTISCUS RESIN (UNII: 7446H202QW)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-847-50	1 in 1 BOX	04/01/2022
1		28 mL in 1 BOTTLE, GLASS; 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	04/01/2022

CLE DE PEAU BEAUTE THE FOUNDATION N   B10 LIGHT BEIGE
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-848
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1092 mg  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	924 mg  in 28 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE TRISODIUM (UNII: 420IP921MB)
ARGAN OIL (UNII: 4V59G5UW9X)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
PALMITIC ACID (UNII: 2V16EO95H1)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TREHALOSE (UNII: B8WCK70T7I)
ALCOHOL (UNII: 3K9958V90M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PISTACIA LENTISCUS RESIN (UNII: 7446H202QW)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-848-50	1 in 1 BOX	04/01/2022
1		28 mL in 1 BOTTLE, GLASS; 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	04/01/2022

CLE DE PEAU BEAUTE THE FOUNDATION N   B20 LIGHT MEDIUM BEIGE
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-849
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1092 mg  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	924 mg  in 28 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE TRISODIUM (UNII: 420IP921MB)
ARGAN OIL (UNII: 4V59G5UW9X)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
PALMITIC ACID (UNII: 2V16EO95H1)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TREHALOSE (UNII: B8WCK70T7I)
ALCOHOL (UNII: 3K9958V90M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PISTACIA LENTISCUS RESIN (UNII: 7446H202QW)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-849-50	1 in 1 BOX	04/01/2022
1		28 mL in 1 BOTTLE, GLASS; 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	04/01/2022

CLE DE PEAU BEAUTE THE FOUNDATION N   B30 MEDIUM BEIGE
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-850
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1092 mg  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	924 mg  in 28 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE TRISODIUM (UNII: 420IP921MB)
ARGAN OIL (UNII: 4V59G5UW9X)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
PALMITIC ACID (UNII: 2V16EO95H1)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TREHALOSE (UNII: B8WCK70T7I)
ALCOHOL (UNII: 3K9958V90M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PISTACIA LENTISCUS RESIN (UNII: 7446H202QW)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-850-50	1 in 1 BOX	04/01/2022
1		28 mL in 1 BOTTLE, GLASS; 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	04/01/2022

CLE DE PEAU BEAUTE THE FOUNDATION N   B40 LIGHT TAN BEIGE
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-851
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1092 mg  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	924 mg  in 28 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE TRISODIUM (UNII: 420IP921MB)
ARGAN OIL (UNII: 4V59G5UW9X)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
PALMITIC ACID (UNII: 2V16EO95H1)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TREHALOSE (UNII: B8WCK70T7I)
ALCOHOL (UNII: 3K9958V90M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PISTACIA LENTISCUS RESIN (UNII: 7446H202QW)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-851-50	1 in 1 BOX	04/01/2022
1		28 mL in 1 BOTTLE, GLASS; 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	04/01/2022

CLE DE PEAU BEAUTE THE FOUNDATION N   B50 TAN BEIGE
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-852
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1092 mg  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	924 mg  in 28 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE TRISODIUM (UNII: 420IP921MB)
ARGAN OIL (UNII: 4V59G5UW9X)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
PALMITIC ACID (UNII: 2V16EO95H1)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TREHALOSE (UNII: B8WCK70T7I)
ALCOHOL (UNII: 3K9958V90M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PISTACIA LENTISCUS RESIN (UNII: 7446H202QW)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-852-50	1 in 1 BOX	04/01/2022
1		28 mL in 1 BOTTLE, GLASS; 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	04/01/2022

CLE DE PEAU BEAUTE THE FOUNDATION N   BF10 LIGHT BUFF
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-853
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1092 mg  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	924 mg  in 28 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE TRISODIUM (UNII: 420IP921MB)
ARGAN OIL (UNII: 4V59G5UW9X)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
PALMITIC ACID (UNII: 2V16EO95H1)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TREHALOSE (UNII: B8WCK70T7I)
ALCOHOL (UNII: 3K9958V90M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PISTACIA LENTISCUS RESIN (UNII: 7446H202QW)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-853-50	1 in 1 BOX	04/01/2022
1		28 mL in 1 BOTTLE, GLASS; 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	04/01/2022

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)