Label: 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
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NDC Code(s):
58411-631-60,
58411-632-60,
58411-634-60,
58411-635-60, view more58411-636-60, 58411-637-60, 58411-638-60, 58411-639-60, 58411-640-60, 58411-641-60, 58411-642-60, 58411-643-60, 58411-644-60, 58411-645-60, 58411-646-60, 58411-647-60, 58411-648-60, 58411-649-60, 58411-650-60, 58411-651-60, 58411-652-60, 58411-653-60, 58411-654-60, 58411-655-60
- Packager: SHISEIDO AMERICAS CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 19, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
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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
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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
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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
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - I10
- PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O10
- PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O40
- PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B40
- PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B50
- PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B60
- PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B70
- PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B80
- PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B90
- PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O30
- PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O50
- PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O60
- PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O70
- PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O80
- PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O90
- PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O100
- PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B10
- PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B20
- PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B30
- PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B100
- PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - BF10
- PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - BF50
- PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - BF60
- PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O20
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INGREDIENTS AND APPEARANCE
CLE DE PEAU BEAUTE RADIANT FOUNDATION N I10
octinoxate and titanium dioxide emulsionProduct 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 POLYISOBUTENE (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 DRUG M020 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N O10
octinoxate and titanium dioxide emulsionProduct 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 POLYISOBUTENE (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 DRUG M020 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N O40
octinoxate and titanium dioxide emulsionProduct 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 POLYISOBUTENE (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 DRUG M020 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N B40
octinoxate and titanium dioxide emulsionProduct 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 POLYISOBUTENE (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 DRUG M020 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N B50
octinoxate and titanium dioxide emulsionProduct 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 POLYISOBUTENE (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 DRUG M020 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N B60
octinoxate and titanium dioxide emulsionProduct 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 POLYISOBUTENE (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 DRUG M020 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N B70
octinoxate and titanium dioxide emulsionProduct 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 POLYISOBUTENE (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 DRUG M020 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N B80
octinoxate and titanium dioxide emulsionProduct 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 POLYISOBUTENE (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 DRUG M020 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N B90
octinoxate and titanium dioxide emulsionProduct 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 POLYISOBUTENE (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 DRUG M020 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N O30
octinoxate and titanium dioxide emulsionProduct 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 POLYISOBUTENE (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 DRUG M020 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N O50
octinoxate and titanium dioxide emulsionProduct 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 POLYISOBUTENE (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 DRUG M020 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N O60
octinoxate and titanium dioxide emulsionProduct 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 POLYISOBUTENE (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 DRUG M020 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N O70
octinoxate and titanium dioxide emulsionProduct 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 POLYISOBUTENE (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 DRUG M020 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N O80
octinoxate and titanium dioxide emulsionProduct 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 POLYISOBUTENE (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 DRUG M020 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N O90
octinoxate and titanium dioxide emulsionProduct 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 POLYISOBUTENE (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 10/01/2025 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 DRUG M020 05/01/2021 10/01/2025 CLE DE PEAU BEAUTE RADIANT FOUNDATION N O100
octinoxate and titanium dioxide emulsionProduct 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 POLYISOBUTENE (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 10/01/2025 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 DRUG M020 05/01/2021 10/01/2025 CLE DE PEAU BEAUTE RADIANT FOUNDATION N B10
octinoxate and titanium dioxide emulsionProduct 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 POLYISOBUTENE (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 08/01/2025 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 DRUG M020 05/01/2021 08/01/2025 CLE DE PEAU BEAUTE RADIANT FOUNDATION N B20
octinoxate and titanium dioxide emulsionProduct 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 POLYISOBUTENE (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 12/01/2025 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 DRUG M020 05/01/2021 12/01/2025 CLE DE PEAU BEAUTE RADIANT FOUNDATION N B30
octinoxate and titanium dioxide emulsionProduct 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 POLYISOBUTENE (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 DRUG M020 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N B100
octinoxate and titanium dioxide emulsionProduct 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 POLYISOBUTENE (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 DRUG M020 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N BF10
octinoxate and titanium dioxide emulsionProduct 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 POLYISOBUTENE (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 DRUG M020 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N BF50
octinoxate and titanium dioxide emulsionProduct 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 POLYISOBUTENE (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 DRUG M020 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N BF60
octinoxate and titanium dioxide emulsionProduct 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 POLYISOBUTENE (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 DRUG M020 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N O20
octinoxate and titanium dioxide emulsionProduct 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 POLYISOBUTENE (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 DRUG M020 05/01/2021 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations Shiseido America Inc. 782677132 ANALYSIS(58411-631, 58411-632, 58411-634, 58411-635, 58411-636, 58411-637, 58411-638, 58411-639, 58411-640, 58411-641, 58411-642, 58411-643, 58411-644, 58411-645, 58411-646, 58411-647, 58411-648, 58411-649, 58411-650, 58411-651, 58411-652, 58411-653, 58411-654, 58411-655) , MANUFACTURE(58411-631, 58411-632, 58411-634, 58411-635, 58411-636, 58411-637, 58411-638, 58411-639, 58411-640, 58411-641, 58411-642, 58411-643, 58411-644, 58411-645, 58411-646, 58411-647, 58411-648, 58411-649, 58411-650, 58411-651, 58411-652, 58411-653, 58411-654, 58411-655)
