Label: CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION BF10- titanium dioxide emulsion
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION I10- titanium dioxide emulsion
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O10- titanium dioxide emulsion
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O20- titanium dioxide emulsion
CLE DE PEAU BEAUTE .......oxide) emulsion
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION B100- titanium dioxide emulsion
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION BF50- titanium dioxide emulsion
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION BF60- titanium dioxide emulsion
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION B90- titanium dioxide emulsion
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NDC Code(s):
58411-537-10,
58411-538-10,
58411-539-10,
58411-540-10, view more58411-541-10, 58411-542-10, 58411-543-10, 58411-544-10, 58411-545-10, 58411-546-10, 58411-547-10, 58411-548-10, 58411-549-10, 58411-550-10, 58411-551-10, 58411-552-10, 58411-553-10, 58411-554-10, 58411-555-10, 58411-556-10, 58411-557-10, 58411-558-10, 58411-559-10, 58411-560-10
- 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 April 17, 2020
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 Ingredients
- Purpose
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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
- reply at least every 2 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 un 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
DIMETHICONE ∙ WATER ∙ POLYMETHYLSILSESQUIOXANE ∙ GLYCERIN ∙ TRIMETHYLSILOXYSILICATE ∙ BUTYLENE GLYCOL ∙ TALC ∙ DIISOSTEARYL MALATE ∙ PEG-10 DIMETHICONE ∙ POLYGLYCERYL-2 DIISOSTEARATE ∙ BARIUM SULFATE ∙ PEG/PPG-19/19 DIMETHICONE ∙ HYDROGENATED POLYISOBUTENE ∙ DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER ∙ TREHALOSE ∙ ARGANIA SPINOSA KERNEL OIL ∙ GLYCINE ∙ PEG/PPG-14/7 DIMETHYL ETHER ∙ ROSA ROXBURGHII FRUIT EXTRACT ∙ ANGELICA ACUTILOBA ROOT EXTRACT ∙ HYDROLYZED CONCHIOLIN PROTEIN ∙ HYDROLYZED SILK ∙ PERILLA OCYMOIDES LEAF EXTRACT ∙ ALUMINUM HYDROXIDE ∙ STEARIC ACID ∙ DISTEARDIMONIUM HECTORITE ∙ BIS-BUTYLDIMETHICONE POLYGLYCERYL-3 ∙ TRISODIUM EDTA ∙ DIMETHICONE CROSSPOLYMER ∙ DISODIUM STEAROYL GLUTAMATE ∙ ZINC OXIDE ∙ TRIETHOXYCAPRYLYLSILANE ∙ POLYSORBATE 80 ∙ ALCOHOL ∙ THEANINE ∙ TOCOPHEROL ∙ HYPERICUM ERECTUM FLOWER/LEAF/STEM EXTRACT ∙ SODIUM METABISULFITE ∙ PHENOXYETHANOL ∙ SODIUM DEHYDROACETATE ∙ FRAGRANCE ∙ IRON OXIDES ∙ TITANIUM DIOXIDE ∙ MICA ∙
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - BF10 - LIGHT BUFF
- PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - I10 - VERY LIGHT IVORY
- PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - O10 - LIGHT OCHER
- PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - O20 - LIGHT MEDIUM OCHER
- PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - O30 - MEDIUM OCHER
- PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - O40 - LIGHT TAN OCHER
- PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - O50 - TAN OCHER
- PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - O60 - DEEP TAN OCHER
- PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - O70 - MEDIUM DEEP OCHER
- PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - O80 - DEEP OCHER
- PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - O90 - VERY DEEP OCHER
- PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - O100 - RICH DEEP OCHER
- PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - B10 - LIGHT BEIGE
- PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - B20 - LIGHT MEDIUM BEIGE
- PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - B30 - MEDIUM BEIGE
- PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - B40 - LIGHT TAN BEIGE
- PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - B50 - TAN BEIGE
- PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - B60 - DEEP TAN BEIGE
- PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - B70 - MEDIUM DEEP BEIGE
- PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - B80 - DEEP BEIGE
- PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - B100 - RICH DEEP BEIGE
- PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - BF50 - TAN BUFF
- PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - BF60 - DEEP TAN BUFF
- PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - B90 - VERY DEEP BEIGE
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INGREDIENTS AND APPEARANCE
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION BF10
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-537 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.72118 g in 35 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) GLYCERIN (UNII: PDC6A3C0OX) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TALC (UNII: 7SEV7J4R1U) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) BARIUM SULFATE (UNII: 25BB7EKE2E) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) EDETATE TRISODIUM (UNII: 420IP921MB) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) ZINC OXIDE (UNII: SOI2LOH54Z) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALCOHOL (UNII: 3K9958V90M) THEANINE (UNII: 8021PR16QO) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-537-10 1 in 1 CARTON 07/01/2020 1 35 mL in 1 BOTTLE; 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 07/01/2020 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION I10
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-538 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.72118 g in 35 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) GLYCERIN (UNII: PDC6A3C0OX) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TALC (UNII: 7SEV7J4R1U) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) BARIUM SULFATE (UNII: 25BB7EKE2E) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) EDETATE TRISODIUM (UNII: 420IP921MB) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) ZINC OXIDE (UNII: SOI2LOH54Z) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALCOHOL (UNII: 3K9958V90M) THEANINE (UNII: 8021PR16QO) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-538-10 1 in 1 CARTON 07/01/2020 1 35 mL in 1 BOTTLE; 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 07/01/2020 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O10
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-539 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.72118 g in 35 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) GLYCERIN (UNII: PDC6A3C0OX) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TALC (UNII: 7SEV7J4R1U) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) BARIUM SULFATE (UNII: 25BB7EKE2E) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) EDETATE TRISODIUM (UNII: 420IP921MB) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) ZINC OXIDE (UNII: SOI2LOH54Z) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALCOHOL (UNII: 3K9958V90M) THEANINE (UNII: 8021PR16QO) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-539-10 1 in 1 CARTON 07/01/2020 1 35 mL in 1 BOTTLE; 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 07/01/2020 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O20
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-540 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.72118 g in 35 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) GLYCERIN (UNII: PDC6A3C0OX) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TALC (UNII: 7SEV7J4R1U) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) BARIUM SULFATE (UNII: 25BB7EKE2E) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) EDETATE TRISODIUM (UNII: 420IP921MB) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) ZINC OXIDE (UNII: SOI2LOH54Z) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALCOHOL (UNII: 3K9958V90M) THEANINE (UNII: 8021PR16QO) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-540-10 1 in 1 CARTON 07/01/2020 1 35 mL in 1 BOTTLE; 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 07/01/2020 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O30
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-541 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.72118 g in 35 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) GLYCERIN (UNII: PDC6A3C0OX) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TALC (UNII: 7SEV7J4R1U) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) BARIUM SULFATE (UNII: 25BB7EKE2E) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) EDETATE TRISODIUM (UNII: 420IP921MB) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) ZINC OXIDE (UNII: SOI2LOH54Z) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALCOHOL (UNII: 3K9958V90M) THEANINE (UNII: 8021PR16QO) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-541-10 1 in 1 CARTON 07/01/2020 1 35 mL in 1 BOTTLE; 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 07/01/2020 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O40
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-542 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.72118 g in 35 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) GLYCERIN (UNII: PDC6A3C0OX) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TALC (UNII: 7SEV7J4R1U) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) BARIUM SULFATE (UNII: 25BB7EKE2E) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) EDETATE TRISODIUM (UNII: 420IP921MB) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) ZINC OXIDE (UNII: SOI2LOH54Z) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALCOHOL (UNII: 3K9958V90M) THEANINE (UNII: 8021PR16QO) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-542-10 1 in 1 CARTON 07/01/2020 1 35 mL in 1 BOTTLE; 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 07/01/2020 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O50
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-543 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.72118 g in 35 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) GLYCERIN (UNII: PDC6A3C0OX) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TALC (UNII: 7SEV7J4R1U) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) BARIUM SULFATE (UNII: 25BB7EKE2E) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) EDETATE TRISODIUM (UNII: 420IP921MB) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) ZINC OXIDE (UNII: SOI2LOH54Z) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALCOHOL (UNII: 3K9958V90M) THEANINE (UNII: 8021PR16QO) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-543-10 1 in 1 CARTON 07/01/2020 1 35 mL in 1 BOTTLE; 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 07/01/2020 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O60
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-544 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.72118 g in 35 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) GLYCERIN (UNII: PDC6A3C0OX) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TALC (UNII: 7SEV7J4R1U) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) BARIUM SULFATE (UNII: 25BB7EKE2E) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) EDETATE TRISODIUM (UNII: 420IP921MB) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) ZINC OXIDE (UNII: SOI2LOH54Z) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALCOHOL (UNII: 3K9958V90M) THEANINE (UNII: 8021PR16QO) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-544-10 1 in 1 CARTON 07/01/2020 1 35 mL in 1 BOTTLE; 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 07/01/2020 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O70
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-545 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.72118 g in 35 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) GLYCERIN (UNII: PDC6A3C0OX) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TALC (UNII: 7SEV7J4R1U) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) BARIUM SULFATE (UNII: 25BB7EKE2E) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) EDETATE TRISODIUM (UNII: 420IP921MB) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) ZINC OXIDE (UNII: SOI2LOH54Z) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALCOHOL (UNII: 3K9958V90M) THEANINE (UNII: 8021PR16QO) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-545-10 1 in 1 CARTON 07/01/2020 1 35 mL in 1 BOTTLE; 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 07/01/2020 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O80
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-546 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.72118 g in 35 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) GLYCERIN (UNII: PDC6A3C0OX) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TALC (UNII: 7SEV7J4R1U) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) BARIUM SULFATE (UNII: 25BB7EKE2E) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) EDETATE TRISODIUM (UNII: 420IP921MB) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) ZINC OXIDE (UNII: SOI2LOH54Z) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALCOHOL (UNII: 3K9958V90M) THEANINE (UNII: 8021PR16QO) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-546-10 1 in 1 CARTON 07/01/2020 1 35 mL in 1 BOTTLE; 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 07/01/2020 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O90
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-547 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.72118 g in 35 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) GLYCERIN (UNII: PDC6A3C0OX) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TALC (UNII: 7SEV7J4R1U) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) BARIUM SULFATE (UNII: 25BB7EKE2E) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) EDETATE TRISODIUM (UNII: 420IP921MB) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) ZINC OXIDE (UNII: SOI2LOH54Z) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALCOHOL (UNII: 3K9958V90M) THEANINE (UNII: 8021PR16QO) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-547-10 1 in 1 CARTON 07/01/2020 1 35 mL in 1 BOTTLE; 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 07/01/2020 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O100
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-548 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.72118 g in 35 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) GLYCERIN (UNII: PDC6A3C0OX) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TALC (UNII: 7SEV7J4R1U) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) BARIUM SULFATE (UNII: 25BB7EKE2E) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) EDETATE TRISODIUM (UNII: 420IP921MB) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) ZINC OXIDE (UNII: SOI2LOH54Z) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALCOHOL (UNII: 3K9958V90M) THEANINE (UNII: 8021PR16QO) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-548-10 1 in 1 CARTON 07/01/2020 1 35 mL in 1 BOTTLE; 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 07/01/2020 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION B10
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-549 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.72118 g in 35 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) GLYCERIN (UNII: PDC6A3C0OX) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TALC (UNII: 7SEV7J4R1U) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) BARIUM SULFATE (UNII: 25BB7EKE2E) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) EDETATE TRISODIUM (UNII: 420IP921MB) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) ZINC OXIDE (UNII: SOI2LOH54Z) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALCOHOL (UNII: 3K9958V90M) THEANINE (UNII: 8021PR16QO) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-549-10 1 in 1 CARTON 07/01/2020 1 35 mL in 1 BOTTLE; 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 07/01/2020 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION B20
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-550 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.72118 g in 35 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) GLYCERIN (UNII: PDC6A3C0OX) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TALC (UNII: 7SEV7J4R1U) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) BARIUM SULFATE (UNII: 25BB7EKE2E) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) EDETATE TRISODIUM (UNII: 420IP921MB) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) ZINC OXIDE (UNII: SOI2LOH54Z) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALCOHOL (UNII: 3K9958V90M) THEANINE (UNII: 8021PR16QO) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-550-10 1 in 1 CARTON 07/01/2020 1 35 mL in 1 BOTTLE; 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 07/01/2020 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION B30
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-551 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.72118 g in 35 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) GLYCERIN (UNII: PDC6A3C0OX) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TALC (UNII: 7SEV7J4R1U) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) BARIUM SULFATE (UNII: 25BB7EKE2E) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) EDETATE TRISODIUM (UNII: 420IP921MB) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) ZINC OXIDE (UNII: SOI2LOH54Z) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALCOHOL (UNII: 3K9958V90M) THEANINE (UNII: 8021PR16QO) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-551-10 1 in 1 CARTON 07/01/2020 1 35 mL in 1 BOTTLE; 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 07/01/2020 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION B40
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-552 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.72118 g in 35 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) GLYCERIN (UNII: PDC6A3C0OX) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TALC (UNII: 7SEV7J4R1U) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) BARIUM SULFATE (UNII: 25BB7EKE2E) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) EDETATE TRISODIUM (UNII: 420IP921MB) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) ZINC OXIDE (UNII: SOI2LOH54Z) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALCOHOL (UNII: 3K9958V90M) THEANINE (UNII: 8021PR16QO) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-552-10 1 in 1 CARTON 07/01/2020 1 35 mL in 1 BOTTLE; 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 07/01/2020 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION B50
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-553 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.72118 g in 35 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) GLYCERIN (UNII: PDC6A3C0OX) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TALC (UNII: 7SEV7J4R1U) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) BARIUM SULFATE (UNII: 25BB7EKE2E) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) EDETATE TRISODIUM (UNII: 420IP921MB) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) ZINC OXIDE (UNII: SOI2LOH54Z) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALCOHOL (UNII: 3K9958V90M) THEANINE (UNII: 8021PR16QO) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-553-10 1 in 1 CARTON 07/01/2020 1 35 mL in 1 BOTTLE; 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 07/01/2020 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION B60
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-554 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.72118 g in 35 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) GLYCERIN (UNII: PDC6A3C0OX) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TALC (UNII: 7SEV7J4R1U) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) BARIUM SULFATE (UNII: 25BB7EKE2E) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) EDETATE TRISODIUM (UNII: 420IP921MB) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) ZINC OXIDE (UNII: SOI2LOH54Z) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALCOHOL (UNII: 3K9958V90M) THEANINE (UNII: 8021PR16QO) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-554-10 1 in 1 CARTON 07/01/2020 1 35 mL in 1 BOTTLE; 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 07/01/2020 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION B70
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-555 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.72118 g in 35 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) GLYCERIN (UNII: PDC6A3C0OX) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TALC (UNII: 7SEV7J4R1U) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) BARIUM SULFATE (UNII: 25BB7EKE2E) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) EDETATE TRISODIUM (UNII: 420IP921MB) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) ZINC OXIDE (UNII: SOI2LOH54Z) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALCOHOL (UNII: 3K9958V90M) THEANINE (UNII: 8021PR16QO) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-555-10 1 in 1 CARTON 07/01/2020 1 35 mL in 1 BOTTLE; 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 07/01/2020 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION B80
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-556 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.72118 g in 35 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) GLYCERIN (UNII: PDC6A3C0OX) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TALC (UNII: 7SEV7J4R1U) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) BARIUM SULFATE (UNII: 25BB7EKE2E) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) EDETATE TRISODIUM (UNII: 420IP921MB) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) ZINC OXIDE (UNII: SOI2LOH54Z) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALCOHOL (UNII: 3K9958V90M) THEANINE (UNII: 8021PR16QO) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-556-10 1 in 1 CARTON 07/01/2020 1 35 mL in 1 BOTTLE; 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 07/01/2020 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION B100
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-557 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.72118 g in 35 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) GLYCERIN (UNII: PDC6A3C0OX) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TALC (UNII: 7SEV7J4R1U) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) BARIUM SULFATE (UNII: 25BB7EKE2E) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) EDETATE TRISODIUM (UNII: 420IP921MB) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) ZINC OXIDE (UNII: SOI2LOH54Z) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALCOHOL (UNII: 3K9958V90M) THEANINE (UNII: 8021PR16QO) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-557-10 1 in 1 CARTON 07/01/2020 1 35 mL in 1 BOTTLE; 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 07/01/2020 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION BF50
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-558 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.72118 g in 35 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) GLYCERIN (UNII: PDC6A3C0OX) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TALC (UNII: 7SEV7J4R1U) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) BARIUM SULFATE (UNII: 25BB7EKE2E) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) EDETATE TRISODIUM (UNII: 420IP921MB) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) ZINC OXIDE (UNII: SOI2LOH54Z) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALCOHOL (UNII: 3K9958V90M) THEANINE (UNII: 8021PR16QO) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-558-10 1 in 1 CARTON 07/01/2020 1 35 mL in 1 BOTTLE; 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 07/01/2020 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION BF60
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-559 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.72118 g in 35 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) GLYCERIN (UNII: PDC6A3C0OX) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TALC (UNII: 7SEV7J4R1U) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) BARIUM SULFATE (UNII: 25BB7EKE2E) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) EDETATE TRISODIUM (UNII: 420IP921MB) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) ZINC OXIDE (UNII: SOI2LOH54Z) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALCOHOL (UNII: 3K9958V90M) THEANINE (UNII: 8021PR16QO) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-559-10 1 in 1 CARTON 07/01/2020 1 35 mL in 1 BOTTLE; 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 07/01/2020 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION B90
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-560 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.72118 g in 35 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) GLYCERIN (UNII: PDC6A3C0OX) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TALC (UNII: 7SEV7J4R1U) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) BARIUM SULFATE (UNII: 25BB7EKE2E) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) EDETATE TRISODIUM (UNII: 420IP921MB) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) ZINC OXIDE (UNII: SOI2LOH54Z) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALCOHOL (UNII: 3K9958V90M) THEANINE (UNII: 8021PR16QO) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-560-10 1 in 1 CARTON 07/01/2020 1 35 mL in 1 BOTTLE; 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 07/01/2020 Labeler - SHISEIDO AMERICAS CORPORATION (193691821)