Label: CLE DE PEAU BEAUTE UV PROTECTIVE TINTED IVORY- octinoxate, octocrylene, and titanium dioxide cream
CLE DE PEAU BEAUTE UV PROTECTIVE TINTED OCHER- octinoxate, octocrylene, and titanium dioxide cream
CLE DE PEAU BEAUTE UV PROTECTIVE TINTED DARK- octinoxate, octocrylene, and titanium dioxide cream
- NDC Code(s): 58411-292-60, 58411-293-60, 58411-294-60
- Packager: SHISEIDO AMERICAS CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 INGREDIENT
-
Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
-
Directions
- 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
WATER•DIPROPYLENE GLYCOL•DIMETHICONE•ISOPROPYL MYRISTATE•GLYCERIN•CYCLOPENTASILOXANE•SD ALCOHOL 40-B•LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE•METHYL METHACRYLATE CROSSPOLYMER•DISTEARDIMONIUM HECTORITE•POLYMETHYLSILSESQUIOXANE•PEG/PPG-14/7 DIMETHYL ETHER•CETYL PEG/PPG-10/1 DIMETHICONE•SILICA•SORBITAN SESQUIISOSTEARATE•TREHALOSE•DEXTRIN PALMITATE•TOCOPHERYL ACETATE•POLYQUATERNIUM-51•SODIUM ACETYLATED HYALURONATE•DIPOTASSIUM GLYCYRRHIZATE•SAXIFRAGA SARMENTOSA EXTRACT•GINKGO BILOBA LEAF EXTRACT•THYMUS SERPYLLUM EXTRACT•HYDROLYZED SILK•2-O-ETHYL ASCORBIC ACID•SCUTELLARIA BAICALENSIS ROOT EXTRACT•UNCARIA GAMBIR EXTRACT•GARCINIA MANGOSTANA BARK EXTRACT•HIBISCUS SABDARIFFA FLOWER EXTRACT•PANAX GINSENG ROOT EXTRACT•BUPLEURUM FALCATUM ROOT EXTRACT•HYDROLYZED CONCHIOLIN PROTEIN•PPG-17•HYDRATED SILICA•TRIETHOXYCAPRYLYLSILANE•BUTYLENE GLYCOL•TRISODIUM EDTA•ALUMINUM HYDROXIDE•POLYSILICONE-2•ALCOHOL•DISTEARYLDIMONIUM CHLORIDE•BHT•TOCOPHEROL•SODIUM METABISULFITE•TALC•THEANINE•METHYLPARABEN•PHENOXYETHANOL•FRAGRANCE•TITANIUM DIOXIDE•IRON OXIDES•MICA•
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - IVORY
- PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - OCHER
- PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - DARK
-
INGREDIENTS AND APPEARANCE
CLE DE PEAU BEAUTE UV PROTECTIVE TINTED IVORY
octinoxate, octocrylene, and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-292 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2449 mg in 30 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 993 mg in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1522 mg in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPROPYLENE GLYCOL (UNII: E107L85C40) DIMETHICONE (UNII: 92RU3N3Y1O) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) GLYCERIN (UNII: PDC6A3C0OX) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TREHALOSE (UNII: B8WCK70T7I) DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) GINKGO (UNII: 19FUJ2C58T) THYMUS SERPYLLUM (UNII: 86H4S6K51N) 2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) GARCINIA MANGOSTANA BARK (UNII: N6A4WY566I) HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M) ASIAN GINSENG (UNII: CUQ3A77YXI) BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY) PPG-17 (UNII: OV0Q322E0U) HYDRATED SILICA (UNII: Y6O7T4G8P9) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) EDETATE TRISODIUM (UNII: 420IP921MB) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALCOHOL (UNII: 3K9958V90M) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) SODIUM METABISULFITE (UNII: 4VON5FNS3C) TALC (UNII: 7SEV7J4R1U) THEANINE (UNII: 8021PR16QO) METHYLPARABEN (UNII: A2I8C7HI9T) PHENOXYETHANOL (UNII: HIE492ZZ3T) 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:58411-292-60 1 in 1 CARTON 02/01/2017 1 30 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2017 CLE DE PEAU BEAUTE UV PROTECTIVE TINTED OCHER
octinoxate, octocrylene, and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-293 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2449 mg in 30 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 993 mg in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1522 mg in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPROPYLENE GLYCOL (UNII: E107L85C40) DIMETHICONE (UNII: 92RU3N3Y1O) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) GLYCERIN (UNII: PDC6A3C0OX) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TREHALOSE (UNII: B8WCK70T7I) DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) GINKGO (UNII: 19FUJ2C58T) THYMUS SERPYLLUM (UNII: 86H4S6K51N) 2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) GARCINIA MANGOSTANA BARK (UNII: N6A4WY566I) HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M) ASIAN GINSENG (UNII: CUQ3A77YXI) BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY) PPG-17 (UNII: OV0Q322E0U) HYDRATED SILICA (UNII: Y6O7T4G8P9) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) EDETATE TRISODIUM (UNII: 420IP921MB) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALCOHOL (UNII: 3K9958V90M) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) SODIUM METABISULFITE (UNII: 4VON5FNS3C) TALC (UNII: 7SEV7J4R1U) THEANINE (UNII: 8021PR16QO) METHYLPARABEN (UNII: A2I8C7HI9T) PHENOXYETHANOL (UNII: HIE492ZZ3T) 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:58411-293-60 1 in 1 CARTON 02/01/2017 1 30 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2017 CLE DE PEAU BEAUTE UV PROTECTIVE TINTED DARK
octinoxate, octocrylene, and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-294 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2449 mg in 30 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 993 mg in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1522 mg in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPROPYLENE GLYCOL (UNII: E107L85C40) DIMETHICONE (UNII: 92RU3N3Y1O) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) GLYCERIN (UNII: PDC6A3C0OX) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TREHALOSE (UNII: B8WCK70T7I) DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) GINKGO (UNII: 19FUJ2C58T) THYMUS SERPYLLUM (UNII: 86H4S6K51N) 2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) GARCINIA MANGOSTANA BARK (UNII: N6A4WY566I) HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M) ASIAN GINSENG (UNII: CUQ3A77YXI) BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY) PPG-17 (UNII: OV0Q322E0U) HYDRATED SILICA (UNII: Y6O7T4G8P9) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) EDETATE TRISODIUM (UNII: 420IP921MB) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALCOHOL (UNII: 3K9958V90M) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) SODIUM METABISULFITE (UNII: 4VON5FNS3C) TALC (UNII: 7SEV7J4R1U) THEANINE (UNII: 8021PR16QO) METHYLPARABEN (UNII: A2I8C7HI9T) PHENOXYETHANOL (UNII: HIE492ZZ3T) 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:58411-294-60 1 in 1 CARTON 02/01/2017 1 30 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2017 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 manufacture(58411-292, 58411-293, 58411-294) , analysis(58411-292, 58411-293, 58411-294)
