Label: CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL B30- octinoxate and titanium dioxide emulsion
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL BF60- octinoxate and titanium dioxide emulsion
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL BF50- octinoxate and titanium dioxide emulsion
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL B .......URAL O30- octinoxate and titanium dioxide emulsion
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL B20- octinoxate and titanium dioxide emulsion
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL B40- octinoxate and titanium dioxide emulsion
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL B70- octinoxate and titanium dioxide emulsion
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NDC Code(s):
58411-896-20,
58411-896-70,
58411-897-20,
58411-897-70, view more58411-898-20, 58411-898-70, 58411-899-20, 58411-899-70, 58411-900-20, 58411-900-70, 58411-901-20, 58411-901-70, 58411-906-20, 58411-906-70, 58411-908-20, 58411-908-70, 58411-909-20, 58411-909-70, 58411-910-20, 58411-910-70, 58411-911-20, 58411-911-70, 58411-912-20, 58411-912-70, 58411-913-20, 58411-913-70, 58411-914-20, 58411-914-70, 58411-915-20, 58411-915-70, 58411-916-20, 58411-916-70, 58411-917-20, 58411-917-70, 58411-918-20, 58411-918-70, 58411-919-20, 58411-919-70, 58411-920-20, 58411-920-70, 58411-921-20, 58411-921-70, 58411-922-20, 58411-922-70, 58411-923-20, 58411-923-70
- Packager: SHISEIDO AMERICAS CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 9, 2026
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 2 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
WATERï½¥DIMETHICONEï½¥GLYCERINï½¥BUTYLENE GLYCOLï½¥TRIMETHYLSILOXYSILICATEï½¥POLYMETHYLSILSESQUIOXANEï½¥ISODODECANEï½¥CAPRYLYL METHICONEï½¥BIS-BUTYLDIMETHICONE POLYGLYCERYL-3ï½¥PEG-10 DIMETHICONEï½¥ISOPROPYL MYRISTATEï½¥SYNTHETIC FLUORPHLOGOPITEï½¥DIMETHICONE/PEG-10/15 CROSSPOLYMERï½¥ERYTHRITOLï½¥XYLITOLï½¥BARIUM SULFATEï½¥PYRUS CYDONIA SEED EXTRACTï½¥TREHALOSEï½¥ARGANIA SPINOSA KERNEL OILï½¥GLYCINEï½¥PEG/PPG-14/7 DIMETHYL ETHERï½¥CITRUS JUNOS SEED EXTRACTï½¥ROSA ROXBURGHII FRUIT EXTRACTï½¥ANGELICA ACUTILOBA ROOT EXTRACTï½¥HYDROLYZED CONCHIOLIN PROTEINï½¥HYDROLYZED SILKï½¥DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMERï½¥PERILLA OCYMOIDES LEAF EXTRACTï½¥ISOSTEARIC ACIDï½¥BIS-BEHENYL/PHYTOSTERYL DIMER DILINOLEATEï½¥DIISOSTEARYL MALATEï½¥DISTEARDIMONIUM HECTORITEï½¥ALUMINUM HYDROXIDEï½¥STEARIC ACIDï½¥TRISODIUM EDTAï½¥POLYSILICONE-2ï½¥TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONEï½¥BHTï½¥ALCOHOLï½¥CITRIC ACIDï½¥SODIUM CITRATEï½¥TRIETHOXYCAPRYLYLSILANEï½¥DIPROPYLENE GLYCOLï½¥TOCOPHEROLï½¥DISODIUM STEAROYL GLUTAMATEï½¥SODIUM METABISULFITEï½¥THEANINEï½¥PHENOXYETHANOLï½¥METHYLPARABENï½¥FRAGRANCEï½¥TITANIUM DIOXIDEï½¥IRON OXIDESï½¥MICAï½¥
- Other information
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL - 35 mL Vial Carton - BF10
- PRINCIPAL DISPLAY PANEL - 35 mL Vial Carton - O80
- PRINCIPAL DISPLAY PANEL - 35 mL Vial Carton - O90
- PRINCIPAL DISPLAY PANEL - 35 mL Vial Carton - B50
- PRINCIPAL DISPLAY PANEL - 35 mL Vial Carton - B60
- PRINCIPAL DISPLAY PANEL - 35 mL Vial Carton - B80
- PRINCIPAL DISPLAY PANEL - 35 mL Vial Carton - B10
- PRINCIPAL DISPLAY PANEL - 35 mL Vial Carton - B100
- PRINCIPAL DISPLAY PANEL - 35 mL Vial Carton - B20
- PRINCIPAL DISPLAY PANEL - 35 mL Vial Carton - B30
- PRINCIPAL DISPLAY PANEL - 35 mL Vial Carton - B40
- PRINCIPAL DISPLAY PANEL - 35 mL Vial Carton - B70
- PRINCIPAL DISPLAY PANEL - 35 mL Vial Carton - B90
- PRINCIPAL DISPLAY PANEL - 35 mL Vial Carton - BF50
- PRINCIPAL DISPLAY PANEL - 35 mL Vial Carton - BF60
- PRINCIPAL DISPLAY PANEL - 35 mL Vial Carton - I10
- PRINCIPAL DISPLAY PANEL - 35 mL Vial Carton - O10
- PRINCIPAL DISPLAY PANEL - 35 mL Vial Carton - O100
- PRINCIPAL DISPLAY PANEL - 35 mL Vial Carton - O20
- PRINCIPAL DISPLAY PANEL - 35 mL Vial Carton - O30
- PRINCIPAL DISPLAY PANEL - 35 mL Vial Carton - O40
- PRINCIPAL DISPLAY PANEL - 35 mL Vial Carton - O50
- PRINCIPAL DISPLAY PANEL - 35 mL Vial Carton - O60
- PRINCIPAL DISPLAY PANEL - 35 mL Vial Carton - O70
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INGREDIENTS AND APPEARANCE
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURALÂ B30
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-909 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.715 g  in 35 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.155 g  in 35 mL Inactive Ingredients Ingredient Name Strength PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  CITRUS JUNOS SEED (UNII: UY43O1Q45N)  ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW) (UNII: 2428CXY2LA)  HYDROLYZED SHEEP WOOL KERATIN (200 MW) (UNII: R6K7AW17SU)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  ISOSTEARIC ACID (UNII: X33R8U0062)  BEHENYL PHOSPHATE (UNII: 366D9UAY69)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  STEARIC ACID (UNII: 4ELV7Z65AP)  EDETATE TRISODIUM (UNII: 420IP921MB)  POLYSILICONE-15 (UNII: F8DRP5BB29)  TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  ALCOHOL (UNII: 3K9958V90M)  CITRIC ACID ACETATE (UNII: DSO12WL7AU)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  TOCOPHEROL (UNII: R0ZB2556P8)  DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  SODIUM METABISULFITE (UNII: 4VON5FNS3C)  THEANINE (UNII: 8021PR16QO)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  METHYLPARABEN (UNII: A2I8C7HI9T)  FRAGRANCE 13576 (UNII: 5EM498GW35)  BROWN IRON OXIDE (UNII: 1N032N7MFO)  MICA (UNII: V8A1AW0880)  WATER (UNII: 059QF0KO0R)  DIMETHICONE (UNII: 92RU3N3Y1O)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  ISODODECANE (UNII: A8289P68Y2)  CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  BIS(BUTYLAMINO)DIMETHYLSILANE (UNII: YG6YAQ6XCX)  PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)  ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  ERYTHRIN (UNII: 4TJZ1118I8)  XYLITOL (UNII: VCQ006KQ1E)  BARIUM SULFATE (UNII: 25BB7EKE2E)  CYDONIA OBLONGA SEED (UNII: JXU526QH1V)  TREHALOSE (UNII: B8WCK70T7I)  ARGAN OIL (UNII: 4V59G5UW9X)  GLYCINE (UNII: TE7660XO1C)  Product Characteristics Color brown Score     Shape Size Flavor Imprint Code Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-909-20 35 in 1 CARTON 01/01/2021 1 NDC:58411-909-70 35 mL in 1 VIAL; 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 01/01/2021 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL BF60
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-914 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.715 g  in 35 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.155 g  in 35 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID ACETATE (UNII: DSO12WL7AU)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  TOCOPHEROL (UNII: R0ZB2556P8)  DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  SODIUM METABISULFITE (UNII: 4VON5FNS3C)  THEANINE (UNII: 8021PR16QO)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  METHYLPARABEN (UNII: A2I8C7HI9T)  FRAGRANCE 13576 (UNII: 5EM498GW35)  BROWN IRON OXIDE (UNII: 1N032N7MFO)  MICA (UNII: V8A1AW0880)  WATER (UNII: 059QF0KO0R)  DIMETHICONE (UNII: 92RU3N3Y1O)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  ISODODECANE (UNII: A8289P68Y2)  CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  BIS(BUTYLAMINO)DIMETHYLSILANE (UNII: YG6YAQ6XCX)  PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)  ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  ERYTHRIN (UNII: 4TJZ1118I8)  XYLITOL (UNII: VCQ006KQ1E)  BARIUM SULFATE (UNII: 25BB7EKE2E)  CYDONIA OBLONGA SEED (UNII: JXU526QH1V)  TREHALOSE (UNII: B8WCK70T7I)  ARGAN OIL (UNII: 4V59G5UW9X)  GLYCINE (UNII: TE7660XO1C)  CITRUS JUNOS SEED (UNII: UY43O1Q45N)  ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW) (UNII: 2428CXY2LA)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  HYDROLYZED SHEEP WOOL KERATIN (200 MW) (UNII: R6K7AW17SU)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  ISOSTEARIC ACID (UNII: X33R8U0062)  BEHENYL PHOSPHATE (UNII: 366D9UAY69)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  STEARIC ACID (UNII: 4ELV7Z65AP)  EDETATE TRISODIUM (UNII: 420IP921MB)  POLYSILICONE-15 (UNII: F8DRP5BB29)  TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  ALCOHOL (UNII: 3K9958V90M)  Product Characteristics Color brown Score     Shape Size Flavor Imprint Code Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-914-20 35 in 1 CARTON 01/01/2021 1 NDC:58411-914-70 35 mL in 1 VIAL; 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 01/01/2021 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL BF50
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-913 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.715 g  in 35 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.155 g  in 35 mL Inactive Ingredients Ingredient Name Strength BIS(BUTYLAMINO)DIMETHYLSILANE (UNII: YG6YAQ6XCX)  PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)  ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  ERYTHRIN (UNII: 4TJZ1118I8)  XYLITOL (UNII: VCQ006KQ1E)  BARIUM SULFATE (UNII: 25BB7EKE2E)  CYDONIA OBLONGA SEED (UNII: JXU526QH1V)  TREHALOSE (UNII: B8WCK70T7I)  ARGAN OIL (UNII: 4V59G5UW9X)  GLYCINE (UNII: TE7660XO1C)  CITRUS JUNOS SEED (UNII: UY43O1Q45N)  ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW) (UNII: 2428CXY2LA)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  HYDROLYZED SHEEP WOOL KERATIN (200 MW) (UNII: R6K7AW17SU)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  ISOSTEARIC ACID (UNII: X33R8U0062)  BEHENYL PHOSPHATE (UNII: 366D9UAY69)  CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  STEARIC ACID (UNII: 4ELV7Z65AP)  EDETATE TRISODIUM (UNII: 420IP921MB)  POLYSILICONE-15 (UNII: F8DRP5BB29)  TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  ALCOHOL (UNII: 3K9958V90M)  CITRIC ACID ACETATE (UNII: DSO12WL7AU)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  TOCOPHEROL (UNII: R0ZB2556P8)  DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  SODIUM METABISULFITE (UNII: 4VON5FNS3C)  THEANINE (UNII: 8021PR16QO)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  METHYLPARABEN (UNII: A2I8C7HI9T)  FRAGRANCE 13576 (UNII: 5EM498GW35)  BROWN IRON OXIDE (UNII: 1N032N7MFO)  MICA (UNII: V8A1AW0880)  WATER (UNII: 059QF0KO0R)  DIMETHICONE (UNII: 92RU3N3Y1O)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  ISODODECANE (UNII: A8289P68Y2)  Product Characteristics Color brown Score     Shape Size Flavor Imprint Code Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-913-20 35 in 1 CARTON 01/01/2021 1 NDC:58411-913-70 35 mL in 1 VIAL; 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 01/01/2021 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL B90
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-912 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.715 g  in 35 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.155 g  in 35 mL Inactive Ingredients Ingredient Name Strength CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  BIS(BUTYLAMINO)DIMETHYLSILANE (UNII: YG6YAQ6XCX)  PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)  ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  ERYTHRIN (UNII: 4TJZ1118I8)  XYLITOL (UNII: VCQ006KQ1E)  BARIUM SULFATE (UNII: 25BB7EKE2E)  CYDONIA OBLONGA SEED (UNII: JXU526QH1V)  TREHALOSE (UNII: B8WCK70T7I)  ARGAN OIL (UNII: 4V59G5UW9X)  GLYCINE (UNII: TE7660XO1C)  CITRUS JUNOS SEED (UNII: UY43O1Q45N)  ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW) (UNII: 2428CXY2LA)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  HYDROLYZED SHEEP WOOL KERATIN (200 MW) (UNII: R6K7AW17SU)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  ISOSTEARIC ACID (UNII: X33R8U0062)  BEHENYL PHOSPHATE (UNII: 366D9UAY69)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  STEARIC ACID (UNII: 4ELV7Z65AP)  EDETATE TRISODIUM (UNII: 420IP921MB)  POLYSILICONE-15 (UNII: F8DRP5BB29)  TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  ALCOHOL (UNII: 3K9958V90M)  CITRIC ACID ACETATE (UNII: DSO12WL7AU)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  TOCOPHEROL (UNII: R0ZB2556P8)  DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  SODIUM METABISULFITE (UNII: 4VON5FNS3C)  THEANINE (UNII: 8021PR16QO)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  METHYLPARABEN (UNII: A2I8C7HI9T)  FRAGRANCE 13576 (UNII: 5EM498GW35)  BROWN IRON OXIDE (UNII: 1N032N7MFO)  MICA (UNII: V8A1AW0880)  WATER (UNII: 059QF0KO0R)  DIMETHICONE (UNII: 92RU3N3Y1O)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  ISODODECANE (UNII: A8289P68Y2)  Product Characteristics Color brown Score     Shape Size Flavor Imprint Code Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-912-20 35 in 1 CARTON 01/01/2021 1 NDC:58411-912-70 35 mL in 1 VIAL; 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 01/01/2021 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL O40
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-920 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.715 g  in 35 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.155 g  in 35 mL Inactive Ingredients Ingredient Name Strength CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  BIS(BUTYLAMINO)DIMETHYLSILANE (UNII: YG6YAQ6XCX)  PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)  ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  ERYTHRIN (UNII: 4TJZ1118I8)  XYLITOL (UNII: VCQ006KQ1E)  BARIUM SULFATE (UNII: 25BB7EKE2E)  CYDONIA OBLONGA SEED (UNII: JXU526QH1V)  TREHALOSE (UNII: B8WCK70T7I)  ARGAN OIL (UNII: 4V59G5UW9X)  GLYCINE (UNII: TE7660XO1C)  CITRUS JUNOS SEED (UNII: UY43O1Q45N)  ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW) (UNII: 2428CXY2LA)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  HYDROLYZED SHEEP WOOL KERATIN (200 MW) (UNII: R6K7AW17SU)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  ISOSTEARIC ACID (UNII: X33R8U0062)  BEHENYL PHOSPHATE (UNII: 366D9UAY69)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  STEARIC ACID (UNII: 4ELV7Z65AP)  EDETATE TRISODIUM (UNII: 420IP921MB)  POLYSILICONE-15 (UNII: F8DRP5BB29)  TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  ALCOHOL (UNII: 3K9958V90M)  CITRIC ACID ACETATE (UNII: DSO12WL7AU)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  TOCOPHEROL (UNII: R0ZB2556P8)  DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  SODIUM METABISULFITE (UNII: 4VON5FNS3C)  THEANINE (UNII: 8021PR16QO)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  METHYLPARABEN (UNII: A2I8C7HI9T)  FRAGRANCE 13576 (UNII: 5EM498GW35)  BROWN IRON OXIDE (UNII: 1N032N7MFO)  MICA (UNII: V8A1AW0880)  WATER (UNII: 059QF0KO0R)  DIMETHICONE (UNII: 92RU3N3Y1O)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  ISODODECANE (UNII: A8289P68Y2)  Product Characteristics Color brown Score     Shape Size Flavor Imprint Code Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-920-20 35 in 1 CARTON 01/01/2021 1 NDC:58411-920-70 35 mL in 1 VIAL; 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 01/01/2021 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL O10
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-916 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.715 g  in 35 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.155 g  in 35 mL Inactive Ingredients Ingredient Name Strength CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  BIS(BUTYLAMINO)DIMETHYLSILANE (UNII: YG6YAQ6XCX)  PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)  ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  ERYTHRIN (UNII: 4TJZ1118I8)  XYLITOL (UNII: VCQ006KQ1E)  BARIUM SULFATE (UNII: 25BB7EKE2E)  CYDONIA OBLONGA SEED (UNII: JXU526QH1V)  TREHALOSE (UNII: B8WCK70T7I)  ARGAN OIL (UNII: 4V59G5UW9X)  GLYCINE (UNII: TE7660XO1C)  CITRUS JUNOS SEED (UNII: UY43O1Q45N)  ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW) (UNII: 2428CXY2LA)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  HYDROLYZED SHEEP WOOL KERATIN (200 MW) (UNII: R6K7AW17SU)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  ISOSTEARIC ACID (UNII: X33R8U0062)  BEHENYL PHOSPHATE (UNII: 366D9UAY69)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  STEARIC ACID (UNII: 4ELV7Z65AP)  EDETATE TRISODIUM (UNII: 420IP921MB)  POLYSILICONE-15 (UNII: F8DRP5BB29)  TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  ALCOHOL (UNII: 3K9958V90M)  CITRIC ACID ACETATE (UNII: DSO12WL7AU)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  TOCOPHEROL (UNII: R0ZB2556P8)  DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  SODIUM METABISULFITE (UNII: 4VON5FNS3C)  THEANINE (UNII: 8021PR16QO)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  METHYLPARABEN (UNII: A2I8C7HI9T)  FRAGRANCE 13576 (UNII: 5EM498GW35)  BROWN IRON OXIDE (UNII: 1N032N7MFO)  MICA (UNII: V8A1AW0880)  WATER (UNII: 059QF0KO0R)  DIMETHICONE (UNII: 92RU3N3Y1O)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  ISODODECANE (UNII: A8289P68Y2)  Product Characteristics Color brown Score     Shape Size Flavor Imprint Code Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-916-20 35 in 1 CARTON 01/01/2021 1 NDC:58411-916-70 35 mL in 1 VIAL; 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 01/01/2021 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL I100
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-917 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.715 g  in 35 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.155 g  in 35 mL Inactive Ingredients Ingredient Name Strength BIS(BUTYLAMINO)DIMETHYLSILANE (UNII: YG6YAQ6XCX)  CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)  ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  ERYTHRIN (UNII: 4TJZ1118I8)  XYLITOL (UNII: VCQ006KQ1E)  BARIUM SULFATE (UNII: 25BB7EKE2E)  CYDONIA OBLONGA SEED (UNII: JXU526QH1V)  TREHALOSE (UNII: B8WCK70T7I)  ARGAN OIL (UNII: 4V59G5UW9X)  GLYCINE (UNII: TE7660XO1C)  CITRUS JUNOS SEED (UNII: UY43O1Q45N)  ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW) (UNII: 2428CXY2LA)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  HYDROLYZED SHEEP WOOL KERATIN (200 MW) (UNII: R6K7AW17SU)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  ISOSTEARIC ACID (UNII: X33R8U0062)  BEHENYL PHOSPHATE (UNII: 366D9UAY69)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  STEARIC ACID (UNII: 4ELV7Z65AP)  EDETATE TRISODIUM (UNII: 420IP921MB)  POLYSILICONE-15 (UNII: F8DRP5BB29)  TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  ALCOHOL (UNII: 3K9958V90M)  CITRIC ACID ACETATE (UNII: DSO12WL7AU)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  TOCOPHEROL (UNII: R0ZB2556P8)  DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  SODIUM METABISULFITE (UNII: 4VON5FNS3C)  THEANINE (UNII: 8021PR16QO)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  METHYLPARABEN (UNII: A2I8C7HI9T)  FRAGRANCE 13576 (UNII: 5EM498GW35)  BROWN IRON OXIDE (UNII: 1N032N7MFO)  MICA (UNII: V8A1AW0880)  WATER (UNII: 059QF0KO0R)  DIMETHICONE (UNII: 92RU3N3Y1O)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  ISODODECANE (UNII: A8289P68Y2)  Product Characteristics Color brown Score     Shape Size Flavor Imprint Code Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-917-20 35 in 1 CARTON 01/01/2021 1 NDC:58411-917-70 35 mL in 1 VIAL; 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 01/01/2021 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL O50
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-921 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.715 g  in 35 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.155 g  in 35 mL Inactive Ingredients Ingredient Name Strength CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  BIS(BUTYLAMINO)DIMETHYLSILANE (UNII: YG6YAQ6XCX)  PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)  ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  ERYTHRIN (UNII: 4TJZ1118I8)  XYLITOL (UNII: VCQ006KQ1E)  BARIUM SULFATE (UNII: 25BB7EKE2E)  CYDONIA OBLONGA SEED (UNII: JXU526QH1V)  TREHALOSE (UNII: B8WCK70T7I)  ARGAN OIL (UNII: 4V59G5UW9X)  GLYCINE (UNII: TE7660XO1C)  CITRUS JUNOS SEED (UNII: UY43O1Q45N)  ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW) (UNII: 2428CXY2LA)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  HYDROLYZED SHEEP WOOL KERATIN (200 MW) (UNII: R6K7AW17SU)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  ISOSTEARIC ACID (UNII: X33R8U0062)  BEHENYL PHOSPHATE (UNII: 366D9UAY69)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  STEARIC ACID (UNII: 4ELV7Z65AP)  EDETATE TRISODIUM (UNII: 420IP921MB)  POLYSILICONE-15 (UNII: F8DRP5BB29)  TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  ALCOHOL (UNII: 3K9958V90M)  CITRIC ACID ACETATE (UNII: DSO12WL7AU)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  TOCOPHEROL (UNII: R0ZB2556P8)  DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  SODIUM METABISULFITE (UNII: 4VON5FNS3C)  THEANINE (UNII: 8021PR16QO)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  METHYLPARABEN (UNII: A2I8C7HI9T)  FRAGRANCE 13576 (UNII: 5EM498GW35)  BROWN IRON OXIDE (UNII: 1N032N7MFO)  MICA (UNII: V8A1AW0880)  WATER (UNII: 059QF0KO0R)  DIMETHICONE (UNII: 92RU3N3Y1O)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  ISODODECANE (UNII: A8289P68Y2)  Product Characteristics Color brown Score     Shape Size Flavor Imprint Code Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-921-20 35 in 1 CARTON 01/01/2021 1 NDC:58411-921-70 35 mL in 1 VIAL; 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 01/01/2021 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL O70
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-923 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.715 g  in 35 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.155 g  in 35 mL Inactive Ingredients Ingredient Name Strength CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  BIS(BUTYLAMINO)DIMETHYLSILANE (UNII: YG6YAQ6XCX)  PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)  ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  ERYTHRIN (UNII: 4TJZ1118I8)  XYLITOL (UNII: VCQ006KQ1E)  BARIUM SULFATE (UNII: 25BB7EKE2E)  CYDONIA OBLONGA SEED (UNII: JXU526QH1V)  TREHALOSE (UNII: B8WCK70T7I)  ARGAN OIL (UNII: 4V59G5UW9X)  GLYCINE (UNII: TE7660XO1C)  CITRUS JUNOS SEED (UNII: UY43O1Q45N)  ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW) (UNII: 2428CXY2LA)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  HYDROLYZED SHEEP WOOL KERATIN (200 MW) (UNII: R6K7AW17SU)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  ISOSTEARIC ACID (UNII: X33R8U0062)  BEHENYL PHOSPHATE (UNII: 366D9UAY69)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  STEARIC ACID (UNII: 4ELV7Z65AP)  EDETATE TRISODIUM (UNII: 420IP921MB)  POLYSILICONE-15 (UNII: F8DRP5BB29)  TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  ALCOHOL (UNII: 3K9958V90M)  CITRIC ACID ACETATE (UNII: DSO12WL7AU)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  TOCOPHEROL (UNII: R0ZB2556P8)  DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  SODIUM METABISULFITE (UNII: 4VON5FNS3C)  THEANINE (UNII: 8021PR16QO)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  METHYLPARABEN (UNII: A2I8C7HI9T)  FRAGRANCE 13576 (UNII: 5EM498GW35)  BROWN IRON OXIDE (UNII: 1N032N7MFO)  MICA (UNII: V8A1AW0880)  WATER (UNII: 059QF0KO0R)  DIMETHICONE (UNII: 92RU3N3Y1O)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  ISODODECANE (UNII: A8289P68Y2)  Product Characteristics Color brown Score     Shape Size Flavor Imprint Code Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-923-20 35 in 1 CARTON 01/01/2021 1 NDC:58411-923-70 35 mL in 1 VIAL; 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 01/01/2021 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL  BF10
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-901 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.715 g  in 35 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.155 g  in 35 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  DIMETHICONE (UNII: 92RU3N3Y1O)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  ISODODECANE (UNII: A8289P68Y2)  CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  BIS(BUTYLAMINO)DIMETHYLSILANE (UNII: YG6YAQ6XCX)  PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)  ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  ERYTHRIN (UNII: 4TJZ1118I8)  XYLITOL (UNII: VCQ006KQ1E)  BARIUM SULFATE (UNII: 25BB7EKE2E)  CYDONIA OBLONGA SEED (UNII: JXU526QH1V)  TREHALOSE (UNII: B8WCK70T7I)  ARGAN OIL (UNII: 4V59G5UW9X)  GLYCINE (UNII: TE7660XO1C)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  CITRUS JUNOS SEED (UNII: UY43O1Q45N)  ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW) (UNII: 2428CXY2LA)  HYDROLYZED SHEEP WOOL KERATIN (200 MW) (UNII: R6K7AW17SU)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  ISOSTEARIC ACID (UNII: X33R8U0062)  BEHENYL PHOSPHATE (UNII: 366D9UAY69)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  STEARIC ACID (UNII: 4ELV7Z65AP)  EDETATE TRISODIUM (UNII: 420IP921MB)  POLYSILICONE-15 (UNII: F8DRP5BB29)  TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  ALCOHOL (UNII: 3K9958V90M)  CITRIC ACID ACETATE (UNII: DSO12WL7AU)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  TOCOPHEROL (UNII: R0ZB2556P8)  DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  SODIUM METABISULFITE (UNII: 4VON5FNS3C)  THEANINE (UNII: 8021PR16QO)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  METHYLPARABEN (UNII: A2I8C7HI9T)  FRAGRANCE 13576 (UNII: 5EM498GW35)  BROWN IRON OXIDE (UNII: 1N032N7MFO)  MICA (UNII: V8A1AW0880)  Product Characteristics Color brown Score     Shape Size Flavor Imprint Code Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-901-20 35 in 1 CARTON 01/01/2021 1 NDC:58411-901-70 35 mL in 1 VIAL; 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 01/01/2021 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL  O80
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-896 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.715 g  in 35 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.155 g  in 35 mL Inactive Ingredients Ingredient Name Strength MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  ERYTHRIN (UNII: 4TJZ1118I8)  XYLITOL (UNII: VCQ006KQ1E)  BARIUM SULFATE (UNII: 25BB7EKE2E)  CYDONIA OBLONGA SEED (UNII: JXU526QH1V)  TREHALOSE (UNII: B8WCK70T7I)  ARGAN OIL (UNII: 4V59G5UW9X)  GLYCINE (UNII: TE7660XO1C)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  CITRUS JUNOS SEED (UNII: UY43O1Q45N)  ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW) (UNII: 2428CXY2LA)  HYDROLYZED SHEEP WOOL KERATIN (200 MW) (UNII: R6K7AW17SU)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  WATER (UNII: 059QF0KO0R)  DIMETHICONE (UNII: 92RU3N3Y1O)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  ISODODECANE (UNII: A8289P68Y2)  CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  BIS(BUTYLAMINO)DIMETHYLSILANE (UNII: YG6YAQ6XCX)  PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)  ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  ISOSTEARIC ACID (UNII: X33R8U0062)  BEHENYL PHOSPHATE (UNII: 366D9UAY69)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  STEARIC ACID (UNII: 4ELV7Z65AP)  EDETATE TRISODIUM (UNII: 420IP921MB)  POLYSILICONE-15 (UNII: F8DRP5BB29)  TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  ALCOHOL (UNII: 3K9958V90M)  CITRIC ACID ACETATE (UNII: DSO12WL7AU)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  TOCOPHEROL (UNII: R0ZB2556P8)  DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  SODIUM METABISULFITE (UNII: 4VON5FNS3C)  THEANINE (UNII: 8021PR16QO)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  METHYLPARABEN (UNII: A2I8C7HI9T)  FRAGRANCE 13576 (UNII: 5EM498GW35)  BROWN IRON OXIDE (UNII: 1N032N7MFO)  MICA (UNII: V8A1AW0880)  Product Characteristics Color brown Score     Shape Size Flavor Imprint Code Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-896-20 35 in 1 CARTON 01/01/2021 1 NDC:58411-896-70 35 mL in 1 VIAL; 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 01/01/2021 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL  O90
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-897 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.715 g  in 35 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.155 g  in 35 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  DIMETHICONE (UNII: 92RU3N3Y1O)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  ISODODECANE (UNII: A8289P68Y2)  CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  BIS(BUTYLAMINO)DIMETHYLSILANE (UNII: YG6YAQ6XCX)  PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)  ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  ERYTHRIN (UNII: 4TJZ1118I8)  XYLITOL (UNII: VCQ006KQ1E)  BARIUM SULFATE (UNII: 25BB7EKE2E)  CYDONIA OBLONGA SEED (UNII: JXU526QH1V)  TREHALOSE (UNII: B8WCK70T7I)  ARGAN OIL (UNII: 4V59G5UW9X)  GLYCINE (UNII: TE7660XO1C)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  CITRUS JUNOS SEED (UNII: UY43O1Q45N)  ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW) (UNII: 2428CXY2LA)  HYDROLYZED SHEEP WOOL KERATIN (200 MW) (UNII: R6K7AW17SU)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  ISOSTEARIC ACID (UNII: X33R8U0062)  BEHENYL PHOSPHATE (UNII: 366D9UAY69)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  STEARIC ACID (UNII: 4ELV7Z65AP)  EDETATE TRISODIUM (UNII: 420IP921MB)  POLYSILICONE-15 (UNII: F8DRP5BB29)  TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  ALCOHOL (UNII: 3K9958V90M)  CITRIC ACID ACETATE (UNII: DSO12WL7AU)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  TOCOPHEROL (UNII: R0ZB2556P8)  DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  SODIUM METABISULFITE (UNII: 4VON5FNS3C)  THEANINE (UNII: 8021PR16QO)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  METHYLPARABEN (UNII: A2I8C7HI9T)  FRAGRANCE 13576 (UNII: 5EM498GW35)  BROWN IRON OXIDE (UNII: 1N032N7MFO)  MICA (UNII: V8A1AW0880)  Product Characteristics Color brown Score     Shape Size Flavor Imprint Code Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-897-20 35 in 1 CARTON 01/01/2021 1 NDC:58411-897-70 35 mL in 1 VIAL; 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 01/01/2021 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL  B50
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-898 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.715 g  in 35 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.155 g  in 35 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  DIMETHICONE (UNII: 92RU3N3Y1O)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  ISODODECANE (UNII: A8289P68Y2)  CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  BIS(BUTYLAMINO)DIMETHYLSILANE (UNII: YG6YAQ6XCX)  PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)  ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  ERYTHRIN (UNII: 4TJZ1118I8)  XYLITOL (UNII: VCQ006KQ1E)  BARIUM SULFATE (UNII: 25BB7EKE2E)  CYDONIA OBLONGA SEED (UNII: JXU526QH1V)  TREHALOSE (UNII: B8WCK70T7I)  ARGAN OIL (UNII: 4V59G5UW9X)  GLYCINE (UNII: TE7660XO1C)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  CITRUS JUNOS SEED (UNII: UY43O1Q45N)  ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW) (UNII: 2428CXY2LA)  HYDROLYZED SHEEP WOOL KERATIN (200 MW) (UNII: R6K7AW17SU)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  ISOSTEARIC ACID (UNII: X33R8U0062)  BEHENYL PHOSPHATE (UNII: 366D9UAY69)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  STEARIC ACID (UNII: 4ELV7Z65AP)  EDETATE TRISODIUM (UNII: 420IP921MB)  POLYSILICONE-15 (UNII: F8DRP5BB29)  TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  ALCOHOL (UNII: 3K9958V90M)  CITRIC ACID ACETATE (UNII: DSO12WL7AU)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  TOCOPHEROL (UNII: R0ZB2556P8)  DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  SODIUM METABISULFITE (UNII: 4VON5FNS3C)  THEANINE (UNII: 8021PR16QO)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  METHYLPARABEN (UNII: A2I8C7HI9T)  FRAGRANCE 13576 (UNII: 5EM498GW35)  BROWN IRON OXIDE (UNII: 1N032N7MFO)  MICA (UNII: V8A1AW0880)  Product Characteristics Color brown Score     Shape Size Flavor Imprint Code Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-898-20 35 in 1 CARTON 01/01/2021 1 NDC:58411-898-70 35 mL in 1 VIAL; 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 01/01/2021 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL  B60
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-899 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.715 g  in 35 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.155 g  in 35 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  DIMETHICONE (UNII: 92RU3N3Y1O)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  ISODODECANE (UNII: A8289P68Y2)  CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  BIS(BUTYLAMINO)DIMETHYLSILANE (UNII: YG6YAQ6XCX)  PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)  ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  ERYTHRIN (UNII: 4TJZ1118I8)  XYLITOL (UNII: VCQ006KQ1E)  BARIUM SULFATE (UNII: 25BB7EKE2E)  CYDONIA OBLONGA SEED (UNII: JXU526QH1V)  TREHALOSE (UNII: B8WCK70T7I)  ARGAN OIL (UNII: 4V59G5UW9X)  GLYCINE (UNII: TE7660XO1C)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  CITRUS JUNOS SEED (UNII: UY43O1Q45N)  ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW) (UNII: 2428CXY2LA)  HYDROLYZED SHEEP WOOL KERATIN (200 MW) (UNII: R6K7AW17SU)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  ISOSTEARIC ACID (UNII: X33R8U0062)  BEHENYL PHOSPHATE (UNII: 366D9UAY69)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  STEARIC ACID (UNII: 4ELV7Z65AP)  EDETATE TRISODIUM (UNII: 420IP921MB)  POLYSILICONE-15 (UNII: F8DRP5BB29)  TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  ALCOHOL (UNII: 3K9958V90M)  CITRIC ACID ACETATE (UNII: DSO12WL7AU)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  TOCOPHEROL (UNII: R0ZB2556P8)  DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  SODIUM METABISULFITE (UNII: 4VON5FNS3C)  THEANINE (UNII: 8021PR16QO)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  METHYLPARABEN (UNII: A2I8C7HI9T)  FRAGRANCE 13576 (UNII: 5EM498GW35)  BROWN IRON OXIDE (UNII: 1N032N7MFO)  MICA (UNII: V8A1AW0880)  Product Characteristics Color brown Score     Shape Size Flavor Imprint Code Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-899-20 35 in 1 CARTON 01/01/2021 1 NDC:58411-899-70 35 mL in 1 VIAL; 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 01/01/2021 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL  B80
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-900 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.715 g  in 35 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.155 g  in 35 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  DIMETHICONE (UNII: 92RU3N3Y1O)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  ISODODECANE (UNII: A8289P68Y2)  CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  BIS(BUTYLAMINO)DIMETHYLSILANE (UNII: YG6YAQ6XCX)  PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)  ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  ERYTHRIN (UNII: 4TJZ1118I8)  XYLITOL (UNII: VCQ006KQ1E)  BARIUM SULFATE (UNII: 25BB7EKE2E)  CYDONIA OBLONGA SEED (UNII: JXU526QH1V)  TREHALOSE (UNII: B8WCK70T7I)  ARGAN OIL (UNII: 4V59G5UW9X)  GLYCINE (UNII: TE7660XO1C)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  CITRUS JUNOS SEED (UNII: UY43O1Q45N)  ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW) (UNII: 2428CXY2LA)  HYDROLYZED SHEEP WOOL KERATIN (200 MW) (UNII: R6K7AW17SU)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  ISOSTEARIC ACID (UNII: X33R8U0062)  BEHENYL PHOSPHATE (UNII: 366D9UAY69)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  STEARIC ACID (UNII: 4ELV7Z65AP)  EDETATE TRISODIUM (UNII: 420IP921MB)  POLYSILICONE-15 (UNII: F8DRP5BB29)  TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  ALCOHOL (UNII: 3K9958V90M)  CITRIC ACID ACETATE (UNII: DSO12WL7AU)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  TOCOPHEROL (UNII: R0ZB2556P8)  DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  SODIUM METABISULFITE (UNII: 4VON5FNS3C)  THEANINE (UNII: 8021PR16QO)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  METHYLPARABEN (UNII: A2I8C7HI9T)  FRAGRANCE 13576 (UNII: 5EM498GW35)  BROWN IRON OXIDE (UNII: 1N032N7MFO)  MICA (UNII: V8A1AW0880)  Product Characteristics Color brown Score     Shape Size Flavor Imprint Code Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-900-20 35 in 1 CARTON 01/01/2021 1 NDC:58411-900-70 35 mL in 1 VIAL; 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 01/01/2021 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL O60
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-922 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.715 g  in 35 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.155 g  in 35 mL Inactive Ingredients Ingredient Name Strength CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  BIS(BUTYLAMINO)DIMETHYLSILANE (UNII: YG6YAQ6XCX)  PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)  ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  ERYTHRIN (UNII: 4TJZ1118I8)  XYLITOL (UNII: VCQ006KQ1E)  BARIUM SULFATE (UNII: 25BB7EKE2E)  CYDONIA OBLONGA SEED (UNII: JXU526QH1V)  TREHALOSE (UNII: B8WCK70T7I)  ARGAN OIL (UNII: 4V59G5UW9X)  GLYCINE (UNII: TE7660XO1C)  CITRUS JUNOS SEED (UNII: UY43O1Q45N)  ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW) (UNII: 2428CXY2LA)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  HYDROLYZED SHEEP WOOL KERATIN (200 MW) (UNII: R6K7AW17SU)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  ISOSTEARIC ACID (UNII: X33R8U0062)  BEHENYL PHOSPHATE (UNII: 366D9UAY69)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  STEARIC ACID (UNII: 4ELV7Z65AP)  EDETATE TRISODIUM (UNII: 420IP921MB)  POLYSILICONE-15 (UNII: F8DRP5BB29)  TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  ALCOHOL (UNII: 3K9958V90M)  CITRIC ACID ACETATE (UNII: DSO12WL7AU)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  TOCOPHEROL (UNII: R0ZB2556P8)  DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  SODIUM METABISULFITE (UNII: 4VON5FNS3C)  THEANINE (UNII: 8021PR16QO)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  METHYLPARABEN (UNII: A2I8C7HI9T)  FRAGRANCE 13576 (UNII: 5EM498GW35)  BROWN IRON OXIDE (UNII: 1N032N7MFO)  MICA (UNII: V8A1AW0880)  WATER (UNII: 059QF0KO0R)  DIMETHICONE (UNII: 92RU3N3Y1O)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  ISODODECANE (UNII: A8289P68Y2)  Product Characteristics Color brown Score     Shape Size Flavor Imprint Code Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-922-20 35 in 1 CARTON 01/01/2021 1 NDC:58411-922-70 35 mL in 1 VIAL; 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 01/01/2021 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL B10
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-906 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.715 g  in 35 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.155 g  in 35 mL Inactive Ingredients Ingredient Name Strength PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  CITRUS JUNOS SEED (UNII: UY43O1Q45N)  ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW) (UNII: 2428CXY2LA)  HYDROLYZED SHEEP WOOL KERATIN (200 MW) (UNII: R6K7AW17SU)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  ISOSTEARIC ACID (UNII: X33R8U0062)  BEHENYL PHOSPHATE (UNII: 366D9UAY69)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  STEARIC ACID (UNII: 4ELV7Z65AP)  EDETATE TRISODIUM (UNII: 420IP921MB)  POLYSILICONE-15 (UNII: F8DRP5BB29)  TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  ALCOHOL (UNII: 3K9958V90M)  CITRIC ACID ACETATE (UNII: DSO12WL7AU)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  TOCOPHEROL (UNII: R0ZB2556P8)  DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  SODIUM METABISULFITE (UNII: 4VON5FNS3C)  THEANINE (UNII: 8021PR16QO)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  METHYLPARABEN (UNII: A2I8C7HI9T)  FRAGRANCE 13576 (UNII: 5EM498GW35)  BROWN IRON OXIDE (UNII: 1N032N7MFO)  MICA (UNII: V8A1AW0880)  WATER (UNII: 059QF0KO0R)  DIMETHICONE (UNII: 92RU3N3Y1O)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  ISODODECANE (UNII: A8289P68Y2)  CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  BIS(BUTYLAMINO)DIMETHYLSILANE (UNII: YG6YAQ6XCX)  PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)  ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  ERYTHRIN (UNII: 4TJZ1118I8)  XYLITOL (UNII: VCQ006KQ1E)  BARIUM SULFATE (UNII: 25BB7EKE2E)  CYDONIA OBLONGA SEED (UNII: JXU526QH1V)  TREHALOSE (UNII: B8WCK70T7I)  ARGAN OIL (UNII: 4V59G5UW9X)  GLYCINE (UNII: TE7660XO1C)  Product Characteristics Color brown Score     Shape Size Flavor Imprint Code Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-906-20 35 in 1 CARTON 01/01/2021 1 NDC:58411-906-70 35 mL in 1 VIAL; 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 01/01/2021 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL I10
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-915 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.715 g  in 35 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.155 g  in 35 mL Inactive Ingredients Ingredient Name Strength BIS(BUTYLAMINO)DIMETHYLSILANE (UNII: YG6YAQ6XCX)  CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)  ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  ERYTHRIN (UNII: 4TJZ1118I8)  XYLITOL (UNII: VCQ006KQ1E)  BARIUM SULFATE (UNII: 25BB7EKE2E)  CYDONIA OBLONGA SEED (UNII: JXU526QH1V)  TREHALOSE (UNII: B8WCK70T7I)  ARGAN OIL (UNII: 4V59G5UW9X)  GLYCINE (UNII: TE7660XO1C)  CITRUS JUNOS SEED (UNII: UY43O1Q45N)  ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW) (UNII: 2428CXY2LA)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  HYDROLYZED SHEEP WOOL KERATIN (200 MW) (UNII: R6K7AW17SU)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  ISOSTEARIC ACID (UNII: X33R8U0062)  BEHENYL PHOSPHATE (UNII: 366D9UAY69)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  STEARIC ACID (UNII: 4ELV7Z65AP)  EDETATE TRISODIUM (UNII: 420IP921MB)  POLYSILICONE-15 (UNII: F8DRP5BB29)  TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  ALCOHOL (UNII: 3K9958V90M)  CITRIC ACID ACETATE (UNII: DSO12WL7AU)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  TOCOPHEROL (UNII: R0ZB2556P8)  DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  SODIUM METABISULFITE (UNII: 4VON5FNS3C)  THEANINE (UNII: 8021PR16QO)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  METHYLPARABEN (UNII: A2I8C7HI9T)  FRAGRANCE 13576 (UNII: 5EM498GW35)  BROWN IRON OXIDE (UNII: 1N032N7MFO)  MICA (UNII: V8A1AW0880)  WATER (UNII: 059QF0KO0R)  DIMETHICONE (UNII: 92RU3N3Y1O)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  ISODODECANE (UNII: A8289P68Y2)  Product Characteristics Color brown Score     Shape Size Flavor Imprint Code Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-915-20 35 in 1 CARTON 01/01/2021 1 NDC:58411-915-70 35 mL in 1 VIAL; 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 01/01/2021 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL O20
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-918 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.715 g  in 35 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.155 g  in 35 mL Inactive Ingredients Ingredient Name Strength CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  BIS(BUTYLAMINO)DIMETHYLSILANE (UNII: YG6YAQ6XCX)  PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)  ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  ERYTHRIN (UNII: 4TJZ1118I8)  XYLITOL (UNII: VCQ006KQ1E)  BARIUM SULFATE (UNII: 25BB7EKE2E)  CYDONIA OBLONGA SEED (UNII: JXU526QH1V)  TREHALOSE (UNII: B8WCK70T7I)  ARGAN OIL (UNII: 4V59G5UW9X)  GLYCINE (UNII: TE7660XO1C)  CITRUS JUNOS SEED (UNII: UY43O1Q45N)  ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW) (UNII: 2428CXY2LA)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  HYDROLYZED SHEEP WOOL KERATIN (200 MW) (UNII: R6K7AW17SU)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  ISOSTEARIC ACID (UNII: X33R8U0062)  BEHENYL PHOSPHATE (UNII: 366D9UAY69)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  STEARIC ACID (UNII: 4ELV7Z65AP)  EDETATE TRISODIUM (UNII: 420IP921MB)  POLYSILICONE-15 (UNII: F8DRP5BB29)  TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  ALCOHOL (UNII: 3K9958V90M)  CITRIC ACID ACETATE (UNII: DSO12WL7AU)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  TOCOPHEROL (UNII: R0ZB2556P8)  DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  SODIUM METABISULFITE (UNII: 4VON5FNS3C)  THEANINE (UNII: 8021PR16QO)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  METHYLPARABEN (UNII: A2I8C7HI9T)  FRAGRANCE 13576 (UNII: 5EM498GW35)  BROWN IRON OXIDE (UNII: 1N032N7MFO)  MICA (UNII: V8A1AW0880)  WATER (UNII: 059QF0KO0R)  DIMETHICONE (UNII: 92RU3N3Y1O)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  ISODODECANE (UNII: A8289P68Y2)  Product Characteristics Color brown Score     Shape Size Flavor Imprint Code Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-918-20 35 in 1 CARTON 01/01/2021 1 NDC:58411-918-70 35 mL in 1 VIAL; 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 01/01/2021 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL O30
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-919 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.715 g  in 35 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.155 g  in 35 mL Inactive Ingredients Ingredient Name Strength CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  BIS(BUTYLAMINO)DIMETHYLSILANE (UNII: YG6YAQ6XCX)  PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)  ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  ERYTHRIN (UNII: 4TJZ1118I8)  XYLITOL (UNII: VCQ006KQ1E)  BARIUM SULFATE (UNII: 25BB7EKE2E)  CYDONIA OBLONGA SEED (UNII: JXU526QH1V)  TREHALOSE (UNII: B8WCK70T7I)  ARGAN OIL (UNII: 4V59G5UW9X)  GLYCINE (UNII: TE7660XO1C)  CITRUS JUNOS SEED (UNII: UY43O1Q45N)  ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  HYDROLYZED SHEEP WOOL KERATIN (200 MW) (UNII: R6K7AW17SU)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  ISOSTEARIC ACID (UNII: X33R8U0062)  BEHENYL PHOSPHATE (UNII: 366D9UAY69)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  STEARIC ACID (UNII: 4ELV7Z65AP)  EDETATE TRISODIUM (UNII: 420IP921MB)  POLYSILICONE-15 (UNII: F8DRP5BB29)  TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  ALCOHOL (UNII: 3K9958V90M)  CITRIC ACID ACETATE (UNII: DSO12WL7AU)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  TOCOPHEROL (UNII: R0ZB2556P8)  DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  SODIUM METABISULFITE (UNII: 4VON5FNS3C)  THEANINE (UNII: 8021PR16QO)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  METHYLPARABEN (UNII: A2I8C7HI9T)  FRAGRANCE 13576 (UNII: 5EM498GW35)  BROWN IRON OXIDE (UNII: 1N032N7MFO)  MICA (UNII: V8A1AW0880)  WATER (UNII: 059QF0KO0R)  DIMETHICONE (UNII: 92RU3N3Y1O)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  ISODODECANE (UNII: A8289P68Y2)  HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW) (UNII: 2428CXY2LA)  Product Characteristics Color brown Score     Shape Size Flavor Imprint Code Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-919-20 35 in 1 CARTON 01/01/2021 1 NDC:58411-919-70 35 mL in 1 VIAL; 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 01/01/2021 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL B20
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-908 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.715 g  in 35 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.155 g  in 35 mL Inactive Ingredients Ingredient Name Strength PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  CITRUS JUNOS SEED (UNII: UY43O1Q45N)  ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW) (UNII: 2428CXY2LA)  HYDROLYZED SHEEP WOOL KERATIN (200 MW) (UNII: R6K7AW17SU)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  ISOSTEARIC ACID (UNII: X33R8U0062)  BEHENYL PHOSPHATE (UNII: 366D9UAY69)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  STEARIC ACID (UNII: 4ELV7Z65AP)  EDETATE TRISODIUM (UNII: 420IP921MB)  POLYSILICONE-15 (UNII: F8DRP5BB29)  TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  ALCOHOL (UNII: 3K9958V90M)  CITRIC ACID ACETATE (UNII: DSO12WL7AU)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  TOCOPHEROL (UNII: R0ZB2556P8)  DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  SODIUM METABISULFITE (UNII: 4VON5FNS3C)  THEANINE (UNII: 8021PR16QO)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  METHYLPARABEN (UNII: A2I8C7HI9T)  FRAGRANCE 13576 (UNII: 5EM498GW35)  BROWN IRON OXIDE (UNII: 1N032N7MFO)  MICA (UNII: V8A1AW0880)  WATER (UNII: 059QF0KO0R)  DIMETHICONE (UNII: 92RU3N3Y1O)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  ISODODECANE (UNII: A8289P68Y2)  CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  BIS(BUTYLAMINO)DIMETHYLSILANE (UNII: YG6YAQ6XCX)  PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)  ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  ERYTHRIN (UNII: 4TJZ1118I8)  XYLITOL (UNII: VCQ006KQ1E)  BARIUM SULFATE (UNII: 25BB7EKE2E)  CYDONIA OBLONGA SEED (UNII: JXU526QH1V)  TREHALOSE (UNII: B8WCK70T7I)  ARGAN OIL (UNII: 4V59G5UW9X)  GLYCINE (UNII: TE7660XO1C)  Product Characteristics Color brown Score     Shape Size Flavor Imprint Code Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-908-20 35 in 1 CARTON 01/01/2021 1 NDC:58411-908-70 35 mL in 1 VIAL; 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 01/01/2021 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL B40
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-910 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.715 g  in 35 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.155 g  in 35 mL Inactive Ingredients Ingredient Name Strength PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  CITRUS JUNOS SEED (UNII: UY43O1Q45N)  ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW) (UNII: 2428CXY2LA)  HYDROLYZED SHEEP WOOL KERATIN (200 MW) (UNII: R6K7AW17SU)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  ISOSTEARIC ACID (UNII: X33R8U0062)  BEHENYL PHOSPHATE (UNII: 366D9UAY69)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  STEARIC ACID (UNII: 4ELV7Z65AP)  EDETATE TRISODIUM (UNII: 420IP921MB)  POLYSILICONE-15 (UNII: F8DRP5BB29)  TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  ALCOHOL (UNII: 3K9958V90M)  CITRIC ACID ACETATE (UNII: DSO12WL7AU)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  TOCOPHEROL (UNII: R0ZB2556P8)  DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  SODIUM METABISULFITE (UNII: 4VON5FNS3C)  THEANINE (UNII: 8021PR16QO)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  METHYLPARABEN (UNII: A2I8C7HI9T)  FRAGRANCE 13576 (UNII: 5EM498GW35)  BROWN IRON OXIDE (UNII: 1N032N7MFO)  MICA (UNII: V8A1AW0880)  WATER (UNII: 059QF0KO0R)  DIMETHICONE (UNII: 92RU3N3Y1O)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  ISODODECANE (UNII: A8289P68Y2)  CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  BIS(BUTYLAMINO)DIMETHYLSILANE (UNII: YG6YAQ6XCX)  PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)  ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  ERYTHRIN (UNII: 4TJZ1118I8)  XYLITOL (UNII: VCQ006KQ1E)  BARIUM SULFATE (UNII: 25BB7EKE2E)  CYDONIA OBLONGA SEED (UNII: JXU526QH1V)  TREHALOSE (UNII: B8WCK70T7I)  ARGAN OIL (UNII: 4V59G5UW9X)  GLYCINE (UNII: TE7660XO1C)  Product Characteristics Color brown Score     Shape Size Flavor Imprint Code Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-910-20 35 in 1 CARTON 01/01/2021 1 NDC:58411-910-70 35 mL in 1 VIAL; 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 01/01/2021 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL B70
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-911 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.715 g  in 35 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.155 g  in 35 mL Inactive Ingredients Ingredient Name Strength CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  BIS(BUTYLAMINO)DIMETHYLSILANE (UNII: YG6YAQ6XCX)  PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)  ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  ERYTHRIN (UNII: 4TJZ1118I8)  XYLITOL (UNII: VCQ006KQ1E)  BARIUM SULFATE (UNII: 25BB7EKE2E)  CYDONIA OBLONGA SEED (UNII: JXU526QH1V)  TREHALOSE (UNII: B8WCK70T7I)  ARGAN OIL (UNII: 4V59G5UW9X)  GLYCINE (UNII: TE7660XO1C)  CITRUS JUNOS SEED (UNII: UY43O1Q45N)  ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW) (UNII: 2428CXY2LA)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  HYDROLYZED SHEEP WOOL KERATIN (200 MW) (UNII: R6K7AW17SU)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  ISOSTEARIC ACID (UNII: X33R8U0062)  BEHENYL PHOSPHATE (UNII: 366D9UAY69)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  STEARIC ACID (UNII: 4ELV7Z65AP)  EDETATE TRISODIUM (UNII: 420IP921MB)  POLYSILICONE-15 (UNII: F8DRP5BB29)  TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  ALCOHOL (UNII: 3K9958V90M)  CITRIC ACID ACETATE (UNII: DSO12WL7AU)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  TOCOPHEROL (UNII: R0ZB2556P8)  DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  SODIUM METABISULFITE (UNII: 4VON5FNS3C)  THEANINE (UNII: 8021PR16QO)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  METHYLPARABEN (UNII: A2I8C7HI9T)  FRAGRANCE 13576 (UNII: 5EM498GW35)  BROWN IRON OXIDE (UNII: 1N032N7MFO)  MICA (UNII: V8A1AW0880)  WATER (UNII: 059QF0KO0R)  DIMETHICONE (UNII: 92RU3N3Y1O)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  ISODODECANE (UNII: A8289P68Y2)  Product Characteristics Color brown Score     Shape Size Flavor Imprint Code Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-911-20 35 in 1 CARTON 01/01/2021 1 NDC:58411-911-70 35 mL in 1 VIAL; 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 01/01/2021 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Registrant - Shiseido America Inc. (782677132) Establishment Name Address ID/FEI Business Operations Shiseido America Inc. 782677132 analysis(58411-896, 58411-897, 58411-898, 58411-899, 58411-900, 58411-901, 58411-906, 58411-908, 58411-909, 58411-910, 58411-911, 58411-912, 58411-913, 58411-914, 58411-915, 58411-916, 58411-917, 58411-918, 58411-919, 58411-920, 58411-921, 58411-922, 58411-923) , manufacture(58411-896, 58411-897, 58411-898, 58411-899, 58411-900, 58411-901, 58411-906, 58411-908, 58411-909, 58411-910, 58411-911, 58411-912, 58411-913, 58411-914, 58411-915, 58411-916, 58411-917, 58411-918, 58411-919, 58411-920, 58411-921, 58411-922, 58411-923)
























