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
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated March 26, 2021
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
-
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
-
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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE TRISODIUM (UNII: 420IP921MB) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLPARABEN (UNII: 14255EXE39) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GLYCINE (UNII: TE7660XO1C) THEANINE (UNII: 8021PR16QO) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTENTILLA ERECTA ROOT (UNII: BI896CKT6B) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) MICA (UNII: V8A1AW0880) TALC (UNII: 7SEV7J4R1U) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-631-60 1 in 1 CARTON 05/01/2021 1 21 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N O10
octinoxate and titanium dioxide 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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE TRISODIUM (UNII: 420IP921MB) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLPARABEN (UNII: 14255EXE39) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GLYCINE (UNII: TE7660XO1C) THEANINE (UNII: 8021PR16QO) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTENTILLA ERECTA ROOT (UNII: BI896CKT6B) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) MICA (UNII: V8A1AW0880) TALC (UNII: 7SEV7J4R1U) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-632-60 1 in 1 CARTON 05/01/2021 1 21 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N O40
octinoxate and titanium dioxide 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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE TRISODIUM (UNII: 420IP921MB) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLPARABEN (UNII: 14255EXE39) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GLYCINE (UNII: TE7660XO1C) THEANINE (UNII: 8021PR16QO) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTENTILLA ERECTA ROOT (UNII: BI896CKT6B) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) MICA (UNII: V8A1AW0880) TALC (UNII: 7SEV7J4R1U) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-634-60 1 in 1 CARTON 05/01/2021 1 21 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N B40
octinoxate and titanium dioxide 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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE TRISODIUM (UNII: 420IP921MB) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLPARABEN (UNII: 14255EXE39) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GLYCINE (UNII: TE7660XO1C) THEANINE (UNII: 8021PR16QO) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTENTILLA ERECTA ROOT (UNII: BI896CKT6B) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) MICA (UNII: V8A1AW0880) TALC (UNII: 7SEV7J4R1U) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-635-60 1 in 1 CARTON 05/01/2021 1 21 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N B50
octinoxate and titanium dioxide 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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE TRISODIUM (UNII: 420IP921MB) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLPARABEN (UNII: 14255EXE39) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GLYCINE (UNII: TE7660XO1C) THEANINE (UNII: 8021PR16QO) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTENTILLA ERECTA ROOT (UNII: BI896CKT6B) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) MICA (UNII: V8A1AW0880) TALC (UNII: 7SEV7J4R1U) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-636-60 1 in 1 CARTON 05/01/2021 1 21 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N B60
octinoxate and titanium dioxide 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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE TRISODIUM (UNII: 420IP921MB) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLPARABEN (UNII: 14255EXE39) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GLYCINE (UNII: TE7660XO1C) THEANINE (UNII: 8021PR16QO) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTENTILLA ERECTA ROOT (UNII: BI896CKT6B) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) MICA (UNII: V8A1AW0880) TALC (UNII: 7SEV7J4R1U) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-637-60 1 in 1 CARTON 05/01/2021 1 21 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N B70
octinoxate and titanium dioxide 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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE TRISODIUM (UNII: 420IP921MB) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLPARABEN (UNII: 14255EXE39) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GLYCINE (UNII: TE7660XO1C) THEANINE (UNII: 8021PR16QO) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTENTILLA ERECTA ROOT (UNII: BI896CKT6B) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) MICA (UNII: V8A1AW0880) TALC (UNII: 7SEV7J4R1U) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-638-60 1 in 1 CARTON 05/01/2021 1 21 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N B80
octinoxate and titanium dioxide 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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE TRISODIUM (UNII: 420IP921MB) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLPARABEN (UNII: 14255EXE39) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GLYCINE (UNII: TE7660XO1C) THEANINE (UNII: 8021PR16QO) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTENTILLA ERECTA ROOT (UNII: BI896CKT6B) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) MICA (UNII: V8A1AW0880) TALC (UNII: 7SEV7J4R1U) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-639-60 1 in 1 CARTON 05/01/2021 1 21 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N B90
octinoxate and titanium dioxide 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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE TRISODIUM (UNII: 420IP921MB) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLPARABEN (UNII: 14255EXE39) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GLYCINE (UNII: TE7660XO1C) THEANINE (UNII: 8021PR16QO) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTENTILLA ERECTA ROOT (UNII: BI896CKT6B) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) MICA (UNII: V8A1AW0880) TALC (UNII: 7SEV7J4R1U) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-640-60 1 in 1 CARTON 05/01/2021 1 21 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N O30
octinoxate and titanium dioxide 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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE TRISODIUM (UNII: 420IP921MB) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLPARABEN (UNII: 14255EXE39) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GLYCINE (UNII: TE7660XO1C) THEANINE (UNII: 8021PR16QO) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTENTILLA ERECTA ROOT (UNII: BI896CKT6B) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) MICA (UNII: V8A1AW0880) TALC (UNII: 7SEV7J4R1U) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-641-60 1 in 1 CARTON 05/01/2021 1 21 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N O50
octinoxate and titanium dioxide 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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE TRISODIUM (UNII: 420IP921MB) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLPARABEN (UNII: 14255EXE39) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GLYCINE (UNII: TE7660XO1C) THEANINE (UNII: 8021PR16QO) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTENTILLA ERECTA ROOT (UNII: BI896CKT6B) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) MICA (UNII: V8A1AW0880) TALC (UNII: 7SEV7J4R1U) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-642-60 1 in 1 CARTON 05/01/2021 1 21 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N O60
octinoxate and titanium dioxide 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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE TRISODIUM (UNII: 420IP921MB) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLPARABEN (UNII: 14255EXE39) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GLYCINE (UNII: TE7660XO1C) THEANINE (UNII: 8021PR16QO) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTENTILLA ERECTA ROOT (UNII: BI896CKT6B) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) MICA (UNII: V8A1AW0880) TALC (UNII: 7SEV7J4R1U) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-643-60 1 in 1 CARTON 05/01/2021 1 21 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N O70
octinoxate and titanium dioxide 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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE TRISODIUM (UNII: 420IP921MB) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLPARABEN (UNII: 14255EXE39) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GLYCINE (UNII: TE7660XO1C) THEANINE (UNII: 8021PR16QO) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTENTILLA ERECTA ROOT (UNII: BI896CKT6B) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) MICA (UNII: V8A1AW0880) TALC (UNII: 7SEV7J4R1U) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-644-60 1 in 1 CARTON 05/01/2021 1 21 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N O80
octinoxate and titanium dioxide 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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE TRISODIUM (UNII: 420IP921MB) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLPARABEN (UNII: 14255EXE39) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GLYCINE (UNII: TE7660XO1C) THEANINE (UNII: 8021PR16QO) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTENTILLA ERECTA ROOT (UNII: BI896CKT6B) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) MICA (UNII: V8A1AW0880) TALC (UNII: 7SEV7J4R1U) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-645-60 1 in 1 CARTON 05/01/2021 1 21 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N O90
octinoxate and titanium dioxide 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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE TRISODIUM (UNII: 420IP921MB) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLPARABEN (UNII: 14255EXE39) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GLYCINE (UNII: TE7660XO1C) THEANINE (UNII: 8021PR16QO) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTENTILLA ERECTA ROOT (UNII: BI896CKT6B) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) MICA (UNII: V8A1AW0880) TALC (UNII: 7SEV7J4R1U) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-646-60 1 in 1 CARTON 05/01/2021 1 21 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N O100
octinoxate and titanium dioxide 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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE TRISODIUM (UNII: 420IP921MB) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLPARABEN (UNII: 14255EXE39) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GLYCINE (UNII: TE7660XO1C) THEANINE (UNII: 8021PR16QO) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTENTILLA ERECTA ROOT (UNII: BI896CKT6B) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) MICA (UNII: V8A1AW0880) TALC (UNII: 7SEV7J4R1U) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-647-60 1 in 1 CARTON 05/01/2021 1 21 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N B10
octinoxate and titanium dioxide 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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE TRISODIUM (UNII: 420IP921MB) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLPARABEN (UNII: 14255EXE39) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GLYCINE (UNII: TE7660XO1C) THEANINE (UNII: 8021PR16QO) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTENTILLA ERECTA ROOT (UNII: BI896CKT6B) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) MICA (UNII: V8A1AW0880) TALC (UNII: 7SEV7J4R1U) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-648-60 1 in 1 CARTON 05/01/2021 1 21 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N B20
octinoxate and titanium dioxide 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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE TRISODIUM (UNII: 420IP921MB) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLPARABEN (UNII: 14255EXE39) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GLYCINE (UNII: TE7660XO1C) THEANINE (UNII: 8021PR16QO) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTENTILLA ERECTA ROOT (UNII: BI896CKT6B) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) MICA (UNII: V8A1AW0880) TALC (UNII: 7SEV7J4R1U) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-649-60 1 in 1 CARTON 05/01/2021 1 21 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N B30
octinoxate and titanium dioxide 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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE TRISODIUM (UNII: 420IP921MB) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLPARABEN (UNII: 14255EXE39) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GLYCINE (UNII: TE7660XO1C) THEANINE (UNII: 8021PR16QO) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTENTILLA ERECTA ROOT (UNII: BI896CKT6B) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) MICA (UNII: V8A1AW0880) TALC (UNII: 7SEV7J4R1U) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-650-60 1 in 1 CARTON 05/01/2021 1 21 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N B100
octinoxate and titanium dioxide 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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE TRISODIUM (UNII: 420IP921MB) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLPARABEN (UNII: 14255EXE39) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GLYCINE (UNII: TE7660XO1C) THEANINE (UNII: 8021PR16QO) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTENTILLA ERECTA ROOT (UNII: BI896CKT6B) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) MICA (UNII: V8A1AW0880) TALC (UNII: 7SEV7J4R1U) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-651-60 1 in 1 CARTON 05/01/2021 1 21 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N BF10
octinoxate and titanium dioxide 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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE TRISODIUM (UNII: 420IP921MB) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLPARABEN (UNII: 14255EXE39) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GLYCINE (UNII: TE7660XO1C) THEANINE (UNII: 8021PR16QO) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTENTILLA ERECTA ROOT (UNII: BI896CKT6B) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) MICA (UNII: V8A1AW0880) TALC (UNII: 7SEV7J4R1U) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-652-60 1 in 1 CARTON 05/01/2021 1 21 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N BF50
octinoxate and titanium dioxide 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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE TRISODIUM (UNII: 420IP921MB) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLPARABEN (UNII: 14255EXE39) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GLYCINE (UNII: TE7660XO1C) THEANINE (UNII: 8021PR16QO) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTENTILLA ERECTA ROOT (UNII: BI896CKT6B) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) MICA (UNII: V8A1AW0880) TALC (UNII: 7SEV7J4R1U) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-653-60 1 in 1 CARTON 05/01/2021 1 21 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N BF60
octinoxate and titanium dioxide 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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE TRISODIUM (UNII: 420IP921MB) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLPARABEN (UNII: 14255EXE39) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GLYCINE (UNII: TE7660XO1C) THEANINE (UNII: 8021PR16QO) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTENTILLA ERECTA ROOT (UNII: BI896CKT6B) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) MICA (UNII: V8A1AW0880) TALC (UNII: 7SEV7J4R1U) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-654-60 1 in 1 CARTON 05/01/2021 1 21 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/01/2021 CLE DE PEAU BEAUTE RADIANT FOUNDATION N O20
octinoxate and titanium dioxide 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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE TRISODIUM (UNII: 420IP921MB) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLPARABEN (UNII: 14255EXE39) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GLYCINE (UNII: TE7660XO1C) THEANINE (UNII: 8021PR16QO) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTENTILLA ERECTA ROOT (UNII: BI896CKT6B) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) MICA (UNII: V8A1AW0880) TALC (UNII: 7SEV7J4R1U) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-655-60 1 in 1 CARTON 05/01/2021 1 21 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/01/2021 Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
