Label: CLE DE PEAU BEAUTE CONCEALER BUFF- titanium dioxide stick
CLE DE PEAU BEAUTE CONCEALER HAZELNUT- titanium dioxide stick
CLE DE PEAU BEAUTE CONCEALER NUTMEG- titanium dioxide stick
CLE DE PEAU BEAUTE CONCEALER COCOA- titanium dioxide stick
CLE DE PEAU BEAUTE CONCEALER ESPRESSO- titanium dioxide stick
CLE DE PEAU BEAUTE CONCEALER TOFFEE- titanium dioxide stick
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NDC Code(s):
58411-617-20,
58411-618-20,
58411-619-20,
58411-620-20, view more58411-621-20, 58411-622-20
- 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 November 19, 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
-
Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
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Directions
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every two hours
-
Sun Protection Measures.
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:- limit time in the sun, especially from 10 a.m. – 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
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Inactive Ingredients
HYDROGENATED POLYDECENE▪CYCLOPENTASILOXANE▪KAOLIN▪DIPHENYLSILOXY PHENYL TRIMETHICONE▪PARAFFIN▪LITHIUM MAGNESIUM SODIUM SILICATE▪DIISOSTEARYL MALATE▪POLYETHYLENE▪SORBITAN SESQUIISOSTEARATE▪GLYCERIN▪BARIUM SULFATE▪COPERNICIA CERIFERA (CARNAUBA) WAX▪PHYTOSTERYL MACADAMIATE▪TOCOPHERYL ACETATE▪SODIUM ACETYLATED HYALURONATE▪ROSA ROXBURGHII FRUIT EXTRACT▪CAMELLIA SINENSIS LEAF EXTRACT▪PRUNUS SPECIOSA LEAF EXTRACT▪MICROCRYSTALLINE WAX▪DIPROPYLENE GLYCOL▪PEG-10 DIMETHICONE▪WATER▪ALUMINUM HYDROXIDE▪STEARIC ACID▪ALUMINA▪SYNTHETIC FLUORPHLOGOPITE▪BUTYLENE GLYCOL▪TOCOPHEROL▪ALCOHOL▪SIMETHICONE▪TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE▪DIMETHICONE▪BHT▪FRAGRANCE▪IRON OXIDES▪MICA▪TITANIUM DIOXIDE▪
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - BUFF
- PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - HAZELNUT
- PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - NUTMEG
- PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - COCOA
- PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - ESPRESSO
- PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - TOFFEE
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INGREDIENTS AND APPEARANCE
CLE DE PEAU BEAUTE CONCEALER BUFF
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-617 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 80 mg in 5 g Inactive Ingredients Ingredient Name Strength HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) KAOLIN (UNII: 24H4NWX5CO) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) PARAFFIN (UNII: I9O0E3H2ZE) LAPONITE (UNII: D703131383) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) GLYCERIN (UNII: PDC6A3C0OX) CARNAUBA WAX (UNII: R12CBM0EIZ) BARIUM SULFATE (UNII: 25BB7EKE2E) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) DIPROPYLENE GLYCOL (UNII: E107L85C40) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M) ALUMINUM OXIDE (UNII: LMI26O6933) WATER (UNII: 059QF0KO0R) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) ALCOHOL (UNII: 3K9958V90M) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-617-20 1 in 1 CARTON 01/01/2021 1 5 g in 1 CARTRIDGE; 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 01/01/2021 CLE DE PEAU BEAUTE CONCEALER HAZELNUT
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-618 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 80 mg in 5 g Inactive Ingredients Ingredient Name Strength HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) KAOLIN (UNII: 24H4NWX5CO) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) PARAFFIN (UNII: I9O0E3H2ZE) LAPONITE (UNII: D703131383) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) GLYCERIN (UNII: PDC6A3C0OX) CARNAUBA WAX (UNII: R12CBM0EIZ) BARIUM SULFATE (UNII: 25BB7EKE2E) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) DIPROPYLENE GLYCOL (UNII: E107L85C40) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M) ALUMINUM OXIDE (UNII: LMI26O6933) WATER (UNII: 059QF0KO0R) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) ALCOHOL (UNII: 3K9958V90M) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-618-20 1 in 1 CARTON 01/01/2021 1 5 g in 1 CARTRIDGE; 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 01/01/2021 CLE DE PEAU BEAUTE CONCEALER NUTMEG
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-619 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 80 mg in 5 g Inactive Ingredients Ingredient Name Strength HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) MICA (UNII: V8A1AW0880) KAOLIN (UNII: 24H4NWX5CO) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) PARAFFIN (UNII: I9O0E3H2ZE) LAPONITE (UNII: D703131383) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) GLYCERIN (UNII: PDC6A3C0OX) CARNAUBA WAX (UNII: R12CBM0EIZ) BARIUM SULFATE (UNII: 25BB7EKE2E) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) DIPROPYLENE GLYCOL (UNII: E107L85C40) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M) WATER (UNII: 059QF0KO0R) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ALUMINUM OXIDE (UNII: LMI26O6933) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) ALCOHOL (UNII: 3K9958V90M) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-619-20 1 in 1 CARTON 01/01/2021 1 5 g in 1 CARTRIDGE; 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 01/01/2021 CLE DE PEAU BEAUTE CONCEALER COCOA
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-620 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 80 mg in 5 g Inactive Ingredients Ingredient Name Strength FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) MICA (UNII: V8A1AW0880) KAOLIN (UNII: 24H4NWX5CO) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) PARAFFIN (UNII: I9O0E3H2ZE) LAPONITE (UNII: D703131383) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) GLYCERIN (UNII: PDC6A3C0OX) CARNAUBA WAX (UNII: R12CBM0EIZ) BARIUM SULFATE (UNII: 25BB7EKE2E) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) DIPROPYLENE GLYCOL (UNII: E107L85C40) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M) WATER (UNII: 059QF0KO0R) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) ALCOHOL (UNII: 3K9958V90M) ALUMINUM OXIDE (UNII: LMI26O6933) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-620-20 1 in 1 CARTON 01/01/2021 1 5 g in 1 CARTRIDGE; 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 01/01/2021 CLE DE PEAU BEAUTE CONCEALER ESPRESSO
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-621 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 80 mg in 5 g Inactive Ingredients Ingredient Name Strength HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) MICA (UNII: V8A1AW0880) KAOLIN (UNII: 24H4NWX5CO) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) PARAFFIN (UNII: I9O0E3H2ZE) LAPONITE (UNII: D703131383) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) GLYCERIN (UNII: PDC6A3C0OX) CARNAUBA WAX (UNII: R12CBM0EIZ) BARIUM SULFATE (UNII: 25BB7EKE2E) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) DIPROPYLENE GLYCOL (UNII: E107L85C40) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M) WATER (UNII: 059QF0KO0R) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) ALCOHOL (UNII: 3K9958V90M) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALUMINUM OXIDE (UNII: LMI26O6933) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-621-20 1 in 1 CARTON 01/01/2021 1 5 g in 1 CARTRIDGE; 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 01/01/2021 CLE DE PEAU BEAUTE CONCEALER TOFFEE
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-622 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 80 mg in 5 g Inactive Ingredients Ingredient Name Strength HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) MICA (UNII: V8A1AW0880) KAOLIN (UNII: 24H4NWX5CO) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) PARAFFIN (UNII: I9O0E3H2ZE) LAPONITE (UNII: D703131383) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) GLYCERIN (UNII: PDC6A3C0OX) CARNAUBA WAX (UNII: R12CBM0EIZ) BARIUM SULFATE (UNII: 25BB7EKE2E) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) DIPROPYLENE GLYCOL (UNII: E107L85C40) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M) WATER (UNII: 059QF0KO0R) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM OXIDE (UNII: LMI26O6933) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) ALCOHOL (UNII: 3K9958V90M) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-622-20 1 in 1 CARTON 01/01/2021 1 5 g in 1 CARTRIDGE; 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 01/01/2021 Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
