Label: CLE DE PEAU BEAUTE CONCEALER IVORY- titanium dioxide stick
CLE DE PEAU BEAUTE CONCEALER OCHER- titanium dioxide stick
CLE DE PEAU BEAUTE CONCEALER BEIGE- titanium dioxide stick
CLE DE PEAU BEAUTE CONCEALER HONEY- titanium dioxide stick
CLE DE PEAU BEAUTE CONCEALER ALMOND- titanium dioxide stick
CLE DE PEAU BEAUTE CONCEALER MOCHA- titanium dioxide stick
-
NDC Code(s):
58411-353-40,
58411-354-40,
58411-355-40,
58411-356-40, view more58411-357-40, 58411-358-40
- 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 December 13, 2018
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
-
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
-
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
-
Inactive Ingredients
HYDROGENATED POLYDECENE∙CYCLOPENTASILOXANE∙KAOLIN∙DIPHENYLSILOXY PHENYL TRIMETHICONE∙PARAFFIN∙SODIUM MAGNESIUM SILICATE∙DIISOSTEARYL MALATE∙POLYETHYLENE∙SORBITAN SESQUIISOSTEARATE∙GLYCERIN∙COPERNICIA CERIFERA (CARNAUBA) WAX∙BARIUM SULFATE∙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∙ALUMINA∙WATER∙ALUMINUM HYDROXIDE∙STEARIC ACID∙SYNTHETIC FLUORPHLOGOPITE∙BUTYLENE GLYCOL∙TOCOPHEROL∙ALCOHOL∙SIMETHICONE∙TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE∙DIMETHICONE∙BHT∙FRAGRANCE∙TITANIUM DIOXIDE∙IRON OXIDES∙MICA∙
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 5 g Tube Carton - IVORY
- PRINCIPAL DISPLAY PANEL - 5 g Tube Carton - OCHER
- PRINCIPAL DISPLAY PANEL - 5 g Tube Carton - BEIGE
- PRINCIPAL DISPLAY PANEL - 5 g Tube Carton - HONEY
- PRINCIPAL DISPLAY PANEL - 5 g Tube Carton - ALMOND
- PRINCIPAL DISPLAY PANEL - 5 g Tube Carton - MOCHA
-
INGREDIENTS AND APPEARANCE
CLE DE PEAU BEAUTE CONCEALER IVORY
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-353 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 (550 MW) (UNII: U333RI6EB7) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) KAOLIN (UNII: 24H4NWX5CO) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) PARAFFIN (UNII: I9O0E3H2ZE) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) GLYCERIN (UNII: PDC6A3C0OX) CARNAUBA WAX (UNII: R12CBM0EIZ) BARIUM SULFATE (UNII: 25BB7EKE2E) PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) DIPROPYLENE GLYCOL (UNII: E107L85C40) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) ALUMINUM OXIDE (UNII: LMI26O6933) WATER (UNII: 059QF0KO0R) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TOCOPHEROL (UNII: R0ZB2556P8) ALCOHOL (UNII: 3K9958V90M) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 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:58411-353-40 1 in 1 CARTON 02/01/2018 1 5 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/01/2018 CLE DE PEAU BEAUTE CONCEALER OCHER
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-354 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 (550 MW) (UNII: U333RI6EB7) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) KAOLIN (UNII: 24H4NWX5CO) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) PARAFFIN (UNII: I9O0E3H2ZE) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) GLYCERIN (UNII: PDC6A3C0OX) CARNAUBA WAX (UNII: R12CBM0EIZ) BARIUM SULFATE (UNII: 25BB7EKE2E) PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) DIPROPYLENE GLYCOL (UNII: E107L85C40) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) ALUMINUM OXIDE (UNII: LMI26O6933) WATER (UNII: 059QF0KO0R) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TOCOPHEROL (UNII: R0ZB2556P8) ALCOHOL (UNII: 3K9958V90M) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 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:58411-354-40 1 in 1 CARTON 02/01/2018 1 5 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/01/2018 CLE DE PEAU BEAUTE CONCEALER BEIGE
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-355 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 (550 MW) (UNII: U333RI6EB7) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) KAOLIN (UNII: 24H4NWX5CO) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) PARAFFIN (UNII: I9O0E3H2ZE) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) GLYCERIN (UNII: PDC6A3C0OX) CARNAUBA WAX (UNII: R12CBM0EIZ) BARIUM SULFATE (UNII: 25BB7EKE2E) PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) DIPROPYLENE GLYCOL (UNII: E107L85C40) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) ALUMINUM OXIDE (UNII: LMI26O6933) WATER (UNII: 059QF0KO0R) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TOCOPHEROL (UNII: R0ZB2556P8) ALCOHOL (UNII: 3K9958V90M) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 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:58411-355-40 1 in 1 CARTON 02/01/2018 1 5 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/01/2018 CLE DE PEAU BEAUTE CONCEALER HONEY
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-356 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 (550 MW) (UNII: U333RI6EB7) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) KAOLIN (UNII: 24H4NWX5CO) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) PARAFFIN (UNII: I9O0E3H2ZE) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) GLYCERIN (UNII: PDC6A3C0OX) CARNAUBA WAX (UNII: R12CBM0EIZ) BARIUM SULFATE (UNII: 25BB7EKE2E) PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) DIPROPYLENE GLYCOL (UNII: E107L85C40) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) ALUMINUM OXIDE (UNII: LMI26O6933) WATER (UNII: 059QF0KO0R) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TOCOPHEROL (UNII: R0ZB2556P8) ALCOHOL (UNII: 3K9958V90M) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 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:58411-356-40 1 in 1 CARTON 02/01/2018 1 5 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/01/2018 CLE DE PEAU BEAUTE CONCEALER ALMOND
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-357 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 (550 MW) (UNII: U333RI6EB7) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) KAOLIN (UNII: 24H4NWX5CO) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) PARAFFIN (UNII: I9O0E3H2ZE) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) GLYCERIN (UNII: PDC6A3C0OX) CARNAUBA WAX (UNII: R12CBM0EIZ) BARIUM SULFATE (UNII: 25BB7EKE2E) PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) DIPROPYLENE GLYCOL (UNII: E107L85C40) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) ALUMINUM OXIDE (UNII: LMI26O6933) WATER (UNII: 059QF0KO0R) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TOCOPHEROL (UNII: R0ZB2556P8) ALCOHOL (UNII: 3K9958V90M) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 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:58411-357-40 1 in 1 CARTON 02/01/2018 1 5 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/01/2018 CLE DE PEAU BEAUTE CONCEALER MOCHA
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-358 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 (550 MW) (UNII: U333RI6EB7) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) KAOLIN (UNII: 24H4NWX5CO) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) PARAFFIN (UNII: I9O0E3H2ZE) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) GLYCERIN (UNII: PDC6A3C0OX) CARNAUBA WAX (UNII: R12CBM0EIZ) BARIUM SULFATE (UNII: 25BB7EKE2E) PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) DIPROPYLENE GLYCOL (UNII: E107L85C40) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) ALUMINUM OXIDE (UNII: LMI26O6933) WATER (UNII: 059QF0KO0R) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TOCOPHEROL (UNII: R0ZB2556P8) ALCOHOL (UNII: 3K9958V90M) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 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:58411-358-40 1 in 1 CARTON 02/01/2018 1 5 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/01/2018 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 manufacture(58411-353, 58411-354, 58411-355, 58411-356, 58411-357, 58411-358) , analysis(58411-353, 58411-354, 58411-355, 58411-356, 58411-357, 58411-358)
