CLE DE PEAU BEAUTE RADIANT FOUNDATION N I10- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE RADIANT FOUNDATION N O10- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE RADIANT FOUNDATION N O40- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE RADIANT FOUNDATION N B40 (octinoxate and titanium dioxide) emulsi .......E DE PEAU BEAUTE RADIANT FOUNDATION N BF10- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE RADIANT FOUNDATION N BF50- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE RADIANT FOUNDATION N BF60- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE RADIANT FOUNDATION N O20- octinoxate and titanium dioxide emulsion

cle de peau BEAUTE RADIANT FOUNDATION N by

Drug Labeling and Warnings

cle de peau BEAUTE RADIANT 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 4.4%	Sunscreen
TITANIUM DIOXIDE 1.2%	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 two hours
• Sun Protection Measures.
  Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Inactive Ingredients

WATER∙DIMETHICONE∙DIPHENYLSILOXY PHENYL TRIMETHICONE∙DIPROPYLENE GLYCOL∙GLYCERIN∙BUTYLENE GLYCOL∙PEG-10 DIMETHICONE∙PEG-20∙LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE∙PEG-6∙PEG-32∙DISTEARDIMONIUM HECTORITE∙BARIUM SULFATE∙DIPHENYL DIMETHICONE/VINYL DIPHENYL DIMETHICONE/SILSESQUIOXANE CROSSPOLYMER∙DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER∙HYDROGENATED POLYISOBUTENE∙TREHALOSE∙ARGANIA SPINOSA KERNEL OIL∙GLYCINE∙PEG/PPG-14/7 DIMETHYL ETHER∙POTENTILLA ERECTA ROOT EXTRACT∙TRIMETHYLSILOXYSILICATE∙ROSA ROXBURGHII FRUIT EXTRACT∙ANGELICA ACUTILOBA ROOT EXTRACT∙HYDROLYZED CONCHIOLIN PROTEIN∙HYDROLYZED SILK∙PERILLA OCYMOIDES LEAF EXTRACT∙SORBITAN SESQUIISOSTEARATE∙DIISOSTEARYL MALATE∙BEHENIC ACID∙SYNTHETIC FLUORPHLOGOPITE∙ALUMINUM HYDROXIDE∙DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER∙TRISODIUM EDTA∙TALC∙TRIETHOXYCAPRYLYLSILANE∙POLYSILICONE-2∙STEARIC ACID∙TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE∙HYDROGEN DIMETHICONE∙BHT∙SILICA∙THEANINE∙TOCOPHEROL∙POLYMETHYLSILSESQUIOXANE∙METHYLPARABEN∙ETHYLPARABEN∙FRAGRANCE∙IRON OXIDES∙TITANIUM DIOXIDE∙MICA

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 - 21 mL Tube Carton - I10

clé de peau
BEAUTÉ

RADIANT CREAM
FOUNDATION n

BROAD SPECTRUM
SPF 25
SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O10

clé de peau
BEAUTÉ

RADIANT CREAM
FOUNDATION n

BROAD SPECTRUM
SPF 25
SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O40

clé de peau
BEAUTÉ

RADIANT CREAM
FOUNDATION n

BROAD SPECTRUM
SPF 25
SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B40

clé de peau
BEAUTÉ

RADIANT CREAM
FOUNDATION n

BROAD SPECTRUM
SPF 25
SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B50

clé de peau
BEAUTÉ

RADIANT CREAM
FOUNDATION n

BROAD SPECTRUM
SPF 25
SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B60

clé de peau
BEAUTÉ

RADIANT CREAM
FOUNDATION n

BROAD SPECTRUM
SPF 25
SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B70

clé de peau
BEAUTÉ

RADIANT CREAM
FOUNDATION n

BROAD SPECTRUM
SPF 25
SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B80

clé de peau
BEAUTÉ

RADIANT CREAM
FOUNDATION n

BROAD SPECTRUM
SPF 25
SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B90

clé de peau
BEAUTÉ

RADIANT CREAM
FOUNDATION n

BROAD SPECTRUM
SPF 25
SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O30

clé de peau
BEAUTÉ

RADIANT CREAM
FOUNDATION n

BROAD SPECTRUM
SPF 25
SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O50

clé de peau
BEAUTÉ

RADIANT CREAM
FOUNDATION n

BROAD SPECTRUM
SPF 25
SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O60

clé de peau
BEAUTÉ

RADIANT CREAM
FOUNDATION n

BROAD SPECTRUM
SPF 25
SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O70

clé de peau
BEAUTÉ

RADIANT CREAM
FOUNDATION n

BROAD SPECTRUM
SPF 25
SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O80

clé de peau
BEAUTÉ

RADIANT CREAM
FOUNDATION n

BROAD SPECTRUM
SPF 25
SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O90

clé de peau
BEAUTÉ

RADIANT CREAM
FOUNDATION n

BROAD SPECTRUM
SPF 25
SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O100

clé de peau
BEAUTÉ

RADIANT CREAM
FOUNDATION n

BROAD SPECTRUM
SPF 25
SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B10

clé de peau
BEAUTÉ

RADIANT CREAM
FOUNDATION n

BROAD SPECTRUM
SPF 25
SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B20

clé de peau
BEAUTÉ

RADIANT CREAM
FOUNDATION n

BROAD SPECTRUM
SPF 25
SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B30

clé de peau
BEAUTÉ

RADIANT CREAM
FOUNDATION n

BROAD SPECTRUM
SPF 25
SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B100

clé de peau
BEAUTÉ

RADIANT CREAM
FOUNDATION n

BROAD SPECTRUM
SPF 25
SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - BF10

clé de peau
BEAUTÉ

RADIANT CREAM
FOUNDATION n

BROAD SPECTRUM
SPF 25
SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - BF50

clé de peau
BEAUTÉ

RADIANT CREAM
FOUNDATION n

BROAD SPECTRUM
SPF 25
SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - BF60

clé de peau
BEAUTÉ

RADIANT CREAM
FOUNDATION n

BROAD SPECTRUM
SPF 25
SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O20

clé de peau
BEAUTÉ

RADIANT CREAM
FOUNDATION n

BROAD SPECTRUM
SPF 25
SUNSCREEN

21mL NET WT. .88 OZ.

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE RADIANT FOUNDATION N   I10
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-631
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.3 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BEHENIC ACID (UNII: H390488X0A)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE TRISODIUM (UNII: 420IP921MB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLPARABEN (UNII: 14255EXE39)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCINE (UNII: TE7660XO1C)
THEANINE (UNII: 8021PR16QO)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-631-60	1 in 1 CARTON	05/01/2021
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2021

CLE DE PEAU BEAUTE RADIANT FOUNDATION N   O10
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-632
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.3 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BEHENIC ACID (UNII: H390488X0A)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE TRISODIUM (UNII: 420IP921MB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLPARABEN (UNII: 14255EXE39)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCINE (UNII: TE7660XO1C)
THEANINE (UNII: 8021PR16QO)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-632-60	1 in 1 CARTON	05/01/2021
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2021

CLE DE PEAU BEAUTE RADIANT FOUNDATION N   O40
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-634
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.3 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BEHENIC ACID (UNII: H390488X0A)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE TRISODIUM (UNII: 420IP921MB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLPARABEN (UNII: 14255EXE39)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCINE (UNII: TE7660XO1C)
THEANINE (UNII: 8021PR16QO)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-634-60	1 in 1 CARTON	05/01/2021
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2021

CLE DE PEAU BEAUTE RADIANT FOUNDATION N   B40
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-635
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.3 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BEHENIC ACID (UNII: H390488X0A)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE TRISODIUM (UNII: 420IP921MB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLPARABEN (UNII: 14255EXE39)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCINE (UNII: TE7660XO1C)
THEANINE (UNII: 8021PR16QO)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-635-60	1 in 1 CARTON	05/01/2021
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2021

CLE DE PEAU BEAUTE RADIANT FOUNDATION N   B50
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-636
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.3 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BEHENIC ACID (UNII: H390488X0A)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE TRISODIUM (UNII: 420IP921MB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLPARABEN (UNII: 14255EXE39)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCINE (UNII: TE7660XO1C)
THEANINE (UNII: 8021PR16QO)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-636-60	1 in 1 CARTON	05/01/2021
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2021

CLE DE PEAU BEAUTE RADIANT FOUNDATION N   B60
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-637
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.3 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BEHENIC ACID (UNII: H390488X0A)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE TRISODIUM (UNII: 420IP921MB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLPARABEN (UNII: 14255EXE39)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCINE (UNII: TE7660XO1C)
THEANINE (UNII: 8021PR16QO)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-637-60	1 in 1 CARTON	05/01/2021
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2021

CLE DE PEAU BEAUTE RADIANT FOUNDATION N   B70
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-638
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.3 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BEHENIC ACID (UNII: H390488X0A)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE TRISODIUM (UNII: 420IP921MB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLPARABEN (UNII: 14255EXE39)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCINE (UNII: TE7660XO1C)
THEANINE (UNII: 8021PR16QO)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-638-60	1 in 1 CARTON	05/01/2021
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2021

CLE DE PEAU BEAUTE RADIANT FOUNDATION N   B80
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-639
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.3 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BEHENIC ACID (UNII: H390488X0A)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE TRISODIUM (UNII: 420IP921MB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLPARABEN (UNII: 14255EXE39)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCINE (UNII: TE7660XO1C)
THEANINE (UNII: 8021PR16QO)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-639-60	1 in 1 CARTON	05/01/2021
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2021

CLE DE PEAU BEAUTE RADIANT FOUNDATION N   B90
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-640
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.3 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BEHENIC ACID (UNII: H390488X0A)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE TRISODIUM (UNII: 420IP921MB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLPARABEN (UNII: 14255EXE39)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCINE (UNII: TE7660XO1C)
THEANINE (UNII: 8021PR16QO)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-640-60	1 in 1 CARTON	05/01/2021
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2021

CLE DE PEAU BEAUTE RADIANT FOUNDATION N   O30
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-641
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.3 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BEHENIC ACID (UNII: H390488X0A)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE TRISODIUM (UNII: 420IP921MB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLPARABEN (UNII: 14255EXE39)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCINE (UNII: TE7660XO1C)
THEANINE (UNII: 8021PR16QO)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-641-60	1 in 1 CARTON	05/01/2021
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2021

CLE DE PEAU BEAUTE RADIANT FOUNDATION N   O50
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-642
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.3 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BEHENIC ACID (UNII: H390488X0A)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE TRISODIUM (UNII: 420IP921MB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLPARABEN (UNII: 14255EXE39)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCINE (UNII: TE7660XO1C)
THEANINE (UNII: 8021PR16QO)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-642-60	1 in 1 CARTON	05/01/2021
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2021

CLE DE PEAU BEAUTE RADIANT FOUNDATION N   O60
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-643
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.3 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BEHENIC ACID (UNII: H390488X0A)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE TRISODIUM (UNII: 420IP921MB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLPARABEN (UNII: 14255EXE39)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCINE (UNII: TE7660XO1C)
THEANINE (UNII: 8021PR16QO)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-643-60	1 in 1 CARTON	05/01/2021
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2021

CLE DE PEAU BEAUTE RADIANT FOUNDATION N   O70
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-644
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.3 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BEHENIC ACID (UNII: H390488X0A)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE TRISODIUM (UNII: 420IP921MB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLPARABEN (UNII: 14255EXE39)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCINE (UNII: TE7660XO1C)
THEANINE (UNII: 8021PR16QO)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-644-60	1 in 1 CARTON	05/01/2021
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2021

CLE DE PEAU BEAUTE RADIANT FOUNDATION N   O80
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-645
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.3 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BEHENIC ACID (UNII: H390488X0A)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE TRISODIUM (UNII: 420IP921MB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLPARABEN (UNII: 14255EXE39)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCINE (UNII: TE7660XO1C)
THEANINE (UNII: 8021PR16QO)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-645-60	1 in 1 CARTON	05/01/2021
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2021

CLE DE PEAU BEAUTE RADIANT FOUNDATION N   O90
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-646
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.3 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BEHENIC ACID (UNII: H390488X0A)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE TRISODIUM (UNII: 420IP921MB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLPARABEN (UNII: 14255EXE39)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCINE (UNII: TE7660XO1C)
THEANINE (UNII: 8021PR16QO)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-646-60	1 in 1 CARTON	05/01/2021
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2021

CLE DE PEAU BEAUTE RADIANT FOUNDATION N   O100
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-647
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.3 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BEHENIC ACID (UNII: H390488X0A)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE TRISODIUM (UNII: 420IP921MB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLPARABEN (UNII: 14255EXE39)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCINE (UNII: TE7660XO1C)
THEANINE (UNII: 8021PR16QO)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-647-60	1 in 1 CARTON	05/01/2021
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2021

CLE DE PEAU BEAUTE RADIANT FOUNDATION N   B10
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-648
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.3 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BEHENIC ACID (UNII: H390488X0A)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE TRISODIUM (UNII: 420IP921MB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLPARABEN (UNII: 14255EXE39)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCINE (UNII: TE7660XO1C)
THEANINE (UNII: 8021PR16QO)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-648-60	1 in 1 CARTON	05/01/2021
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2021

CLE DE PEAU BEAUTE RADIANT FOUNDATION N   B20
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-649
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.3 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BEHENIC ACID (UNII: H390488X0A)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE TRISODIUM (UNII: 420IP921MB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLPARABEN (UNII: 14255EXE39)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCINE (UNII: TE7660XO1C)
THEANINE (UNII: 8021PR16QO)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-649-60	1 in 1 CARTON	05/01/2021
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2021

CLE DE PEAU BEAUTE RADIANT FOUNDATION N   B30
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-650
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.3 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BEHENIC ACID (UNII: H390488X0A)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE TRISODIUM (UNII: 420IP921MB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLPARABEN (UNII: 14255EXE39)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCINE (UNII: TE7660XO1C)
THEANINE (UNII: 8021PR16QO)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-650-60	1 in 1 CARTON	05/01/2021
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2021

CLE DE PEAU BEAUTE RADIANT FOUNDATION N   B100
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-651
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.3 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BEHENIC ACID (UNII: H390488X0A)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE TRISODIUM (UNII: 420IP921MB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLPARABEN (UNII: 14255EXE39)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCINE (UNII: TE7660XO1C)
THEANINE (UNII: 8021PR16QO)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-651-60	1 in 1 CARTON	05/01/2021
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2021

CLE DE PEAU BEAUTE RADIANT FOUNDATION N   BF10
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-652
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.3 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BEHENIC ACID (UNII: H390488X0A)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE TRISODIUM (UNII: 420IP921MB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLPARABEN (UNII: 14255EXE39)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCINE (UNII: TE7660XO1C)
THEANINE (UNII: 8021PR16QO)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-652-60	1 in 1 CARTON	05/01/2021
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2021

CLE DE PEAU BEAUTE RADIANT FOUNDATION N   BF50
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-653
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.3 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BEHENIC ACID (UNII: H390488X0A)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE TRISODIUM (UNII: 420IP921MB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLPARABEN (UNII: 14255EXE39)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCINE (UNII: TE7660XO1C)
THEANINE (UNII: 8021PR16QO)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-653-60	1 in 1 CARTON	05/01/2021
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2021

CLE DE PEAU BEAUTE RADIANT FOUNDATION N   BF60
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-654
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.3 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BEHENIC ACID (UNII: H390488X0A)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE TRISODIUM (UNII: 420IP921MB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLPARABEN (UNII: 14255EXE39)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCINE (UNII: TE7660XO1C)
THEANINE (UNII: 8021PR16QO)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-654-60	1 in 1 CARTON	05/01/2021
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2021

CLE DE PEAU BEAUTE RADIANT FOUNDATION N   O20
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-655
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.3 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BEHENIC ACID (UNII: H390488X0A)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE TRISODIUM (UNII: 420IP921MB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLPARABEN (UNII: 14255EXE39)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCINE (UNII: TE7660XO1C)
THEANINE (UNII: 8021PR16QO)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-655-60	1 in 1 CARTON	05/01/2021
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2021

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)