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 emulsion 
CLE DE PEAU BEAUTE RADIANT FOUNDATION N  B50- octinoxate and titanium dioxide emulsion 
CLE DE PEAU BEAUTE RADIANT FOUNDATION N  B60- octinoxate and titanium dioxide emulsion 
CLE DE PEAU BEAUTE RADIANT FOUNDATION N  B70- octinoxate and titanium dioxide emulsion 
CLE DE PEAU BEAUTE RADIANT FOUNDATION N  B80- octinoxate and titanium dioxide emulsion 
CLE DE PEAU BEAUTE RADIANT FOUNDATION N  B90- octinoxate and titanium dioxide emulsion 
CLE DE PEAU BEAUTE RADIANT FOUNDATION N  O30- octinoxate and titanium dioxide emulsion 
CLE DE PEAU BEAUTE RADIANT FOUNDATION N  O50- octinoxate and titanium dioxide emulsion 
CLE DE PEAU BEAUTE RADIANT FOUNDATION N  O60- octinoxate and titanium dioxide emulsion 
CLE DE PEAU BEAUTE RADIANT FOUNDATION N  O70- octinoxate and titanium dioxide emulsion 
CLE DE PEAU BEAUTE RADIANT FOUNDATION N  O80- octinoxate and titanium dioxide emulsion 
CLE DE PEAU BEAUTE RADIANT FOUNDATION N  O90- octinoxate and titanium dioxide emulsion 
CLE DE PEAU BEAUTE RADIANT FOUNDATION N  O100- octinoxate and titanium dioxide emulsion 
CLE DE PEAU BEAUTE RADIANT FOUNDATION N  B10- octinoxate and titanium dioxide emulsion 
CLE DE PEAU BEAUTE RADIANT FOUNDATION N  B20- octinoxate and titanium dioxide emulsion 
CLE DE PEAU BEAUTE RADIANT FOUNDATION N  B30- octinoxate and titanium dioxide emulsion 
CLE DE PEAU BEAUTE RADIANT FOUNDATION N  B100- octinoxate and titanium dioxide emulsion 
CLE 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 
SHISEIDO AMERICAS CORPORATION

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

clé de peau BEAUTÉ RADIANT CREAM FOUNDATION N

Drug Facts

Active ingredientsPurpose
OCTINOXATE 4.4%Sunscreen
TITANIUM DIOXIDE 1.2% Sunscreen

Uses

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:

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 - I10

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 - O10

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 - O40

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 - B40

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 - B50

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 - B60

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 - B70

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 - B80

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 - B90

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 - O30

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 - O50

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 - O60

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 - O70

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 - O80

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 - O90

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 - O100

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 - B10

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 - B20

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 - B30

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 - B100

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 - BF10

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 - BF50

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 - BF60

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.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O20
CLE DE PEAU BEAUTE RADIANT FOUNDATION N   I10
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-631
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-631-601 in 1 CARTON05/01/2021
121 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/01/2021
CLE DE PEAU BEAUTE RADIANT FOUNDATION N   O10
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-632
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-632-601 in 1 CARTON05/01/2021
121 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/01/2021
CLE DE PEAU BEAUTE RADIANT FOUNDATION N   O40
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-634
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-634-601 in 1 CARTON05/01/2021
121 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/01/2021
CLE DE PEAU BEAUTE RADIANT FOUNDATION N   B40
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-635
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-635-601 in 1 CARTON05/01/2021
121 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/01/2021
CLE DE PEAU BEAUTE RADIANT FOUNDATION N   B50
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-636
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-636-601 in 1 CARTON05/01/2021
121 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/01/2021
CLE DE PEAU BEAUTE RADIANT FOUNDATION N   B60
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-637
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-637-601 in 1 CARTON05/01/2021
121 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/01/2021
CLE DE PEAU BEAUTE RADIANT FOUNDATION N   B70
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-638
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-638-601 in 1 CARTON05/01/2021
121 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/01/2021
CLE DE PEAU BEAUTE RADIANT FOUNDATION N   B80
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-639
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-639-601 in 1 CARTON05/01/2021
121 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/01/2021
CLE DE PEAU BEAUTE RADIANT FOUNDATION N   B90
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-640
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-640-601 in 1 CARTON05/01/2021
121 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/01/2021
CLE DE PEAU BEAUTE RADIANT FOUNDATION N   O30
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-641
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-641-601 in 1 CARTON05/01/2021
121 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/01/2021
CLE DE PEAU BEAUTE RADIANT FOUNDATION N   O50
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-642
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-642-601 in 1 CARTON05/01/2021
121 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/01/2021
CLE DE PEAU BEAUTE RADIANT FOUNDATION N   O60
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-643
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-643-601 in 1 CARTON05/01/2021
121 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/01/2021
CLE DE PEAU BEAUTE RADIANT FOUNDATION N   O70
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-644
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-644-601 in 1 CARTON05/01/2021
121 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/01/2021
CLE DE PEAU BEAUTE RADIANT FOUNDATION N   O80
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-645
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-645-601 in 1 CARTON05/01/2021
121 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/01/2021
CLE DE PEAU BEAUTE RADIANT FOUNDATION N   O90
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-646
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-646-601 in 1 CARTON05/01/2021
121 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/01/2021
CLE DE PEAU BEAUTE RADIANT FOUNDATION N   O100
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-647
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-647-601 in 1 CARTON05/01/2021
121 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/01/2021
CLE DE PEAU BEAUTE RADIANT FOUNDATION N   B10
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-648
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-648-601 in 1 CARTON05/01/2021
121 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/01/2021
CLE DE PEAU BEAUTE RADIANT FOUNDATION N   B20
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-649
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-649-601 in 1 CARTON05/01/2021
121 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/01/2021
CLE DE PEAU BEAUTE RADIANT FOUNDATION N   B30
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-650
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-650-601 in 1 CARTON05/01/2021
121 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/01/2021
CLE DE PEAU BEAUTE RADIANT FOUNDATION N   B100
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-651
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-651-601 in 1 CARTON05/01/2021
121 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/01/2021
CLE DE PEAU BEAUTE RADIANT FOUNDATION N   BF10
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-652
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-652-601 in 1 CARTON05/01/2021
121 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/01/2021
CLE DE PEAU BEAUTE RADIANT FOUNDATION N   BF50
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-653
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-653-601 in 1 CARTON05/01/2021
121 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/01/2021
CLE DE PEAU BEAUTE RADIANT FOUNDATION N   BF60
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-654
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-654-601 in 1 CARTON05/01/2021
121 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/01/2021
CLE DE PEAU BEAUTE RADIANT FOUNDATION N   O20
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-655
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-655-601 in 1 CARTON05/01/2021
121 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/01/2021
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Revised: 3/2021
Document Id: 28da85e2-c112-4f8e-8cef-316c4b3ae9e3
Set id: 05ffb157-5e28-4e94-866d-9e3371480d84
Version: 1
Effective Time: 20210326
 
SHISEIDO AMERICAS CORPORATION