CLE DE PEAU BEAUTE THE FOUNDATION N M BF10- octinoxate and titanium dioxide paste CLE DE PEAU BEAUTE THE FOUNDATION N M B30- octinoxate and titanium dioxide paste CLE DE PEAU BEAUTE THE FOUNDATION N M O30- octinoxate and titanium dioxide paste CLE DE PEAU BEAUTE THE FOUNDATION N M O10- octinoxate and titanium dioxide paste CLE DE PEAU BEAUTE THE FOUNDATION N M O100- octinoxate and titanium dioxide paste CLE DE PEAU BEAUTE THE FOUNDATION N M B40- octinoxate and titanium dioxide paste CLE DE PEAU BEAUTE THE FOUNDATION N M O40- octinoxate and titanium dioxide paste CLE DE PEAU BEAUTE THE FOUNDATION N M O60- octinoxate and titanium dioxide paste CLE DE PEAU BEAUTE THE FOUNDATION N M I10- octinoxate and titanium dioxide paste CLE DE PEAU BEAUTE THE FOUNDATION N M B20- octinoxate and titanium dioxide paste CLE DE PEAU BEAUTE THE FOUNDATION N M O50- octinoxate and titanium dioxide paste CLE DE PEAU BEAUTE THE FOUNDATION N M O20- octinoxate and titanium dioxide paste CLE DE PEAU BEAUTE THE FOUNDATION N M O80- octinoxate and titanium dioxide paste CLE DE PEAU BEAUTE THE FOUNDATION N M B10- octinoxate and titanium dioxide paste CLE DE PEAU BEAUTE THE FOUNDATION N M B50- octinoxate and titanium dioxide paste

cle de peau BEAUTE THE FOUNDATION N M by

Drug Labeling and Warnings

cle de peau BEAUTE THE FOUNDATION N M by is a Otc medication manufactured, distributed, or labeled by Shiseido Americas Corporation, Shiseido America Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

PURPOSE

• 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

Do not use on damaged or broken skin

WHEN USING

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

STOP USE

Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

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 INGREDIENT

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･CHLORPHENESIN･FRAGRANCE･TITANIUM DIOXIDE･IRON OXIDES･

Other Information

• protect this product in this container from excessive heat and direct sunlight

Questions or Comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 28 mL Jar Carton - O50

clé de peau

BEAUTÉ

THE FOUNDATION N

BROAD SPECTRUM

SPF 22

SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Jar Carton - I10

clé de peau

BEAUTÉ

THE FOUNDATION N

BROAD SPECTRUM

SPF 22

SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Jar Carton - O10

clé de peau

BEAUTÉ

THE FOUNDATION N

BROAD SPECTRUM

SPF 22

SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Jar Carton - O20

clé de peau

BEAUTÉ

THE FOUNDATION N

BROAD SPECTRUM

SPF 22

SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Jar Carton - O30

clé de peau

BEAUTÉ

THE FOUNDATION N

BROAD SPECTRUM

SPF 22

SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Jar Carton - O40

clé de peau

BEAUTÉ

THE FOUNDATION N

BROAD SPECTRUM

SPF 22

SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Jar Carton - O60

clé de peau

BEAUTÉ

THE FOUNDATION N

BROAD SPECTRUM

SPF 22

SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Jar Carton - O80

clé de peau

BEAUTÉ

THE FOUNDATION N

BROAD SPECTRUM

SPF 22

SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Jar Carton - O100

clé de peau

BEAUTÉ

THE FOUNDATION N

BROAD SPECTRUM

SPF 22

SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Jar Carton - B10

clé de peau

BEAUTÉ

THE FOUNDATION N

BROAD SPECTRUM

SPF 22

SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Jar Carton - B20

clé de peau

BEAUTÉ

THE FOUNDATION N

BROAD SPECTRUM

SPF 22

SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Jar Carton - B30

clé de peau

BEAUTÉ

THE FOUNDATION N

BROAD SPECTRUM

SPF 22

SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Jar Carton - B40

clé de peau

BEAUTÉ

THE FOUNDATION N

BROAD SPECTRUM

SPF 22

SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Jar Carton - B50

clé de peau

BEAUTÉ

THE FOUNDATION N

BROAD SPECTRUM

SPF 22

SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Jar Carton - BF10

clé de peau

BEAUTÉ

THE FOUNDATION N

BROAD SPECTRUM

SPF 22

SUNSCREEN

28mL NET WT. 1 OZ.

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE THE FOUNDATION N M  BF10
octinoxate and titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.165 g  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.986 g  in 28 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
TREHALOSE (UNII: B8WCK70T7I)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
WATER (UNII: 059QF0KO0R)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
PISTACIA LENTISCUS (MASTIC) GUM (UNII: 7446H202QW)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRISODIUM EDTA (UNII: 420IP921MB)
HYDROXYPROPYLCELLULOSE (UNII: 9XZ8H6N6OH)
PALMITIC ACID (UNII: 2V16EO95H1)
ALCOHOL (UNII: 3K9958V90M)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-012-10	1 in 1 BOX	12/02/2024
1		28 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE THE FOUNDATION N M  B30
octinoxate and titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.165 g  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.986 g  in 28 mL

Inactive Ingredients
Ingredient Name	Strength
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
TREHALOSE (UNII: B8WCK70T7I)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
PISTACIA LENTISCUS (MASTIC) GUM (UNII: 7446H202QW)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRISODIUM EDTA (UNII: 420IP921MB)
HYDROXYPROPYLCELLULOSE (UNII: 9XZ8H6N6OH)
PALMITIC ACID (UNII: 2V16EO95H1)
ALCOHOL (UNII: 3K9958V90M)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-009-10	1 in 1 BOX	12/02/2024
1		28 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE THE FOUNDATION N M  O30
octinoxate and titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.165 g  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.986 g  in 28 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
TREHALOSE (UNII: B8WCK70T7I)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
WATER (UNII: 059QF0KO0R)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
PISTACIA LENTISCUS (MASTIC) GUM (UNII: 7446H202QW)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRISODIUM EDTA (UNII: 420IP921MB)
HYDROXYPROPYLCELLULOSE (UNII: 9XZ8H6N6OH)
PALMITIC ACID (UNII: 2V16EO95H1)
ALCOHOL (UNII: 3K9958V90M)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-002-10	1 in 1 BOX	12/02/2024
1		28 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE THE FOUNDATION N M  O10
octinoxate and titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-999
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.165 g  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.986 g  in 28 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
TREHALOSE (UNII: B8WCK70T7I)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
WATER (UNII: 059QF0KO0R)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
PISTACIA LENTISCUS (MASTIC) GUM (UNII: 7446H202QW)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRISODIUM EDTA (UNII: 420IP921MB)
HYDROXYPROPYLCELLULOSE (UNII: 9XZ8H6N6OH)
PALMITIC ACID (UNII: 2V16EO95H1)
ALCOHOL (UNII: 3K9958V90M)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-999-10	1 in 1 BOX	12/02/2024
1		28 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE THE FOUNDATION N M  O100
octinoxate and titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.165 g  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.986 g  in 28 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
TREHALOSE (UNII: B8WCK70T7I)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
WATER (UNII: 059QF0KO0R)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
PISTACIA LENTISCUS (MASTIC) GUM (UNII: 7446H202QW)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRISODIUM EDTA (UNII: 420IP921MB)
HYDROXYPROPYLCELLULOSE (UNII: 9XZ8H6N6OH)
PALMITIC ACID (UNII: 2V16EO95H1)
ALCOHOL (UNII: 3K9958V90M)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-006-10	1 in 1 BOX	12/02/2024
1		28 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE THE FOUNDATION N M  B40
octinoxate and titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.165 g  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.986 g  in 28 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
TREHALOSE (UNII: B8WCK70T7I)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
WATER (UNII: 059QF0KO0R)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
PISTACIA LENTISCUS (MASTIC) GUM (UNII: 7446H202QW)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRISODIUM EDTA (UNII: 420IP921MB)
HYDROXYPROPYLCELLULOSE (UNII: 9XZ8H6N6OH)
PALMITIC ACID (UNII: 2V16EO95H1)
ALCOHOL (UNII: 3K9958V90M)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-010-10	1 in 1 BOX	12/02/2024
1		28 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE THE FOUNDATION N M  O40
octinoxate and titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.165 g  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.986 g  in 28 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
TREHALOSE (UNII: B8WCK70T7I)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
WATER (UNII: 059QF0KO0R)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
PISTACIA LENTISCUS (MASTIC) GUM (UNII: 7446H202QW)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRISODIUM EDTA (UNII: 420IP921MB)
HYDROXYPROPYLCELLULOSE (UNII: 9XZ8H6N6OH)
PALMITIC ACID (UNII: 2V16EO95H1)
ALCOHOL (UNII: 3K9958V90M)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-003-10	1 in 1 BOX	12/02/2024
1		28 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE THE FOUNDATION N M  O60
octinoxate and titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.165 g  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.986 g  in 28 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
TREHALOSE (UNII: B8WCK70T7I)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
WATER (UNII: 059QF0KO0R)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
PISTACIA LENTISCUS (MASTIC) GUM (UNII: 7446H202QW)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRISODIUM EDTA (UNII: 420IP921MB)
HYDROXYPROPYLCELLULOSE (UNII: 9XZ8H6N6OH)
PALMITIC ACID (UNII: 2V16EO95H1)
ALCOHOL (UNII: 3K9958V90M)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-004-10	1 in 1 BOX	12/02/2024
1		28 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE THE FOUNDATION N M  I10
octinoxate and titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-998
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.165 g  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.986 g  in 28 mL

Inactive Ingredients
Ingredient Name	Strength
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRISODIUM EDTA (UNII: 420IP921MB)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
TREHALOSE (UNII: B8WCK70T7I)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
WATER (UNII: 059QF0KO0R)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
PISTACIA LENTISCUS (MASTIC) GUM (UNII: 7446H202QW)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
HYDROXYPROPYLCELLULOSE (UNII: 9XZ8H6N6OH)
PALMITIC ACID (UNII: 2V16EO95H1)
ALCOHOL (UNII: 3K9958V90M)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-998-10	1 in 1 BOX	12/02/2024
1		28 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE THE FOUNDATION N M  B20
octinoxate and titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.165 g  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.986 g  in 28 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
TREHALOSE (UNII: B8WCK70T7I)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
WATER (UNII: 059QF0KO0R)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
PISTACIA LENTISCUS (MASTIC) GUM (UNII: 7446H202QW)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRISODIUM EDTA (UNII: 420IP921MB)
HYDROXYPROPYLCELLULOSE (UNII: 9XZ8H6N6OH)
PALMITIC ACID (UNII: 2V16EO95H1)
ALCOHOL (UNII: 3K9958V90M)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-008-10	1 in 1 BOX	12/02/2024
1		28 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE THE FOUNDATION N M  O50
octinoxate and titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-997
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.165 g  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.986 g  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)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
TREHALOSE (UNII: B8WCK70T7I)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
PISTACIA LENTISCUS (MASTIC) GUM (UNII: 7446H202QW)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRISODIUM EDTA (UNII: 420IP921MB)
HYDROXYPROPYLCELLULOSE (UNII: 9XZ8H6N6OH)
PALMITIC ACID (UNII: 2V16EO95H1)
ALCOHOL (UNII: 3K9958V90M)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-997-10	1 in 1 BOX	12/02/2024
1		28 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE THE FOUNDATION N M  O20
octinoxate and titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.165 g  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.986 g  in 28 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
TREHALOSE (UNII: B8WCK70T7I)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
WATER (UNII: 059QF0KO0R)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
PISTACIA LENTISCUS (MASTIC) GUM (UNII: 7446H202QW)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRISODIUM EDTA (UNII: 420IP921MB)
HYDROXYPROPYLCELLULOSE (UNII: 9XZ8H6N6OH)
PALMITIC ACID (UNII: 2V16EO95H1)
ALCOHOL (UNII: 3K9958V90M)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-001-10	1 in 1 BOX	12/02/2024
1		28 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE THE FOUNDATION N M  O80
octinoxate and titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.165 g  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.986 g  in 28 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
TREHALOSE (UNII: B8WCK70T7I)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
WATER (UNII: 059QF0KO0R)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
PISTACIA LENTISCUS (MASTIC) GUM (UNII: 7446H202QW)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRISODIUM EDTA (UNII: 420IP921MB)
HYDROXYPROPYLCELLULOSE (UNII: 9XZ8H6N6OH)
PALMITIC ACID (UNII: 2V16EO95H1)
ALCOHOL (UNII: 3K9958V90M)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-005-10	1 in 1 BOX	12/02/2024
1		28 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE THE FOUNDATION N M  B10
octinoxate and titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.165 g  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.986 g  in 28 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
TREHALOSE (UNII: B8WCK70T7I)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
WATER (UNII: 059QF0KO0R)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
PISTACIA LENTISCUS (MASTIC) GUM (UNII: 7446H202QW)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRISODIUM EDTA (UNII: 420IP921MB)
HYDROXYPROPYLCELLULOSE (UNII: 9XZ8H6N6OH)
PALMITIC ACID (UNII: 2V16EO95H1)
ALCOHOL (UNII: 3K9958V90M)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-007-10	1 in 1 BOX	12/02/2024
1		28 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE THE FOUNDATION N M  B50
octinoxate and titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.165 g  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.986 g  in 28 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
TREHALOSE (UNII: B8WCK70T7I)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
WATER (UNII: 059QF0KO0R)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
PISTACIA LENTISCUS (MASTIC) GUM (UNII: 7446H202QW)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRISODIUM EDTA (UNII: 420IP921MB)
HYDROXYPROPYLCELLULOSE (UNII: 9XZ8H6N6OH)
PALMITIC ACID (UNII: 2V16EO95H1)
ALCOHOL (UNII: 3K9958V90M)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-011-10	1 in 1 BOX	12/02/2024
1		28 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

Labeler - Shiseido Americas Corporation (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
Shiseido America Inc.		782677132	manufacture(58411-001, 58411-002, 58411-003, 58411-004, 58411-005, 58411-006, 58411-007, 58411-008, 58411-009, 58411-010, 58411-011, 58411-012, 58411-997, 58411-998, 58411-999) , analysis(58411-001, 58411-002, 58411-003, 58411-004, 58411-005, 58411-006, 58411-007, 58411-008, 58411-009, 58411-010, 58411-011, 58411-012, 58411-997, 58411-998, 58411-999)