Label: CLE DE PEAU BEAUTE RADIANT FOUNDATION IVORY- octinoxate stick
CLE DE PEAU BEAUTE RADIANT FOUNDATION OCHER- octinoxate stick
CLE DE PEAU BEAUTE RADIANT FOUNDATION MOCHA- octinoxate stick
CLE DE PEAU BEAUTE RADIANT FOUNDATION BEIGE- octinoxate stick
- NDC Code(s): 58411-284-10, 58411-285-10, 58411-286-10, 58411-287-10
- 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 19, 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
DIMETHICONE•WATER•DIPROPYLENE GLYCOL•JOJOBA ESTERS•TRIETHYLHEXANOIN•GLYCERIN•PEG-10 DIMETHICONE•PARAFFIN•POLYETHYLENE•BARIUM SULFATE•TREHALOSE•PEG/PPG-14/7 DIMETHYL ETHER•DIPEPTIDE-15•PAEONIA SUFFRUTICOSA ROOT EXTRACT•ROSA ROXBURGHII FRUIT EXTRACT•DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER•SODIUM ACETYLATED HYALURONATE•TRIMETHYLSILOXYSILICATE•HYDROLYZED SILK•POLYQUATERNIUM-51•HYDROLYZED CONCHIOLIN PROTEIN•SORBITAN SESQUIISOSTEARATE•MICROCRYSTALLINE WAX•PALMITIC ACID•ORYZA SATIVA (RICE) BRAN WAX•DISTEARYLDIMONIUM CHLORIDE•DISTEARDIMONIUM HECTORITE•TRISODIUM EDTA•HYDROGEN DIMETHICONE•POLYMETHYLSILSESQUIOXANE•SODIUM METAPHOSPHATE•ALUMINA•BHT•CELLULOSE GUM•BUTYLENE GLYCOL•ALCOHOL•ISOPROPYL ALCOHOL•TOCOPHEROL•VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER•SYNTHETIC FLUORPHLOGOPITE•PETROLATUM•POLYSILICONE-2•TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE•DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE•THEANINE•SILICA•ALUMINUM HYDROXIDE•METHICONE•TETRADECENE•METHYLPARABEN•ETHYLPARABEN•PHENOXYETHANOL•FRAGRANCE•TITANIUM DIOXIDE•MICA•IRON OXIDES•
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 9 g Bottle Carton - Ivory
- PRINCIPAL DISPLAY PANEL - 9 g Bottle Carton - Ocher
- PRINCIPAL DISPLAY PANEL - 9 g Bottle Carton - Mocha
- PRINCIPAL DISPLAY PANEL - 9 g Bottle Carton - Beige
-
INGREDIENTS AND APPEARANCE
CLE DE PEAU BEAUTE RADIANT FOUNDATION IVORY
octinoxate stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-284 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 306 mg in 9 g Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) GLYCERIN (UNII: PDC6A3C0OX) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) PARAFFIN (UNII: I9O0E3H2ZE) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) BARIUM SULFATE (UNII: 25BB7EKE2E) TREHALOSE (UNII: B8WCK70T7I) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) DIGLYCINE (UNII: 10525P22U0) PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PALMITIC ACID (UNII: 2V16EO95H1) RICE BRAN (UNII: R60QEP13IC) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) EDETATE TRISODIUM (UNII: 420IP921MB) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) ALUMINUM OXIDE (UNII: LMI26O6933) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ALCOHOL (UNII: 3K9958V90M) ISOPROPYL ALCOHOL (UNII: ND2M416302) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) PETROLATUM (UNII: 4T6H12BN9U) DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42) THEANINE (UNII: 8021PR16QO) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) METHICONE (20 CST) (UNII: 6777U11MKT) TETRADECENE (UNII: FW23481S7S) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) PHENOXYETHANOL (UNII: HIE492ZZ3T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-284-10 1 in 1 CARTON 02/01/2017 1 9 g 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 not final part352 02/01/2017 CLE DE PEAU BEAUTE RADIANT FOUNDATION OCHER
octinoxate stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-285 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 306 mg in 9 g Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) GLYCERIN (UNII: PDC6A3C0OX) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) PARAFFIN (UNII: I9O0E3H2ZE) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) BARIUM SULFATE (UNII: 25BB7EKE2E) TREHALOSE (UNII: B8WCK70T7I) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) DIGLYCINE (UNII: 10525P22U0) PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PALMITIC ACID (UNII: 2V16EO95H1) RICE BRAN (UNII: R60QEP13IC) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) EDETATE TRISODIUM (UNII: 420IP921MB) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) ALUMINUM OXIDE (UNII: LMI26O6933) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ALCOHOL (UNII: 3K9958V90M) ISOPROPYL ALCOHOL (UNII: ND2M416302) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) PETROLATUM (UNII: 4T6H12BN9U) DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42) THEANINE (UNII: 8021PR16QO) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) METHICONE (20 CST) (UNII: 6777U11MKT) TETRADECENE (UNII: FW23481S7S) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) PHENOXYETHANOL (UNII: HIE492ZZ3T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-285-10 1 in 1 CARTON 02/01/2017 1 9 g 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 not final part352 02/01/2017 CLE DE PEAU BEAUTE RADIANT FOUNDATION MOCHA
octinoxate stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-286 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 306 mg in 9 g Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) GLYCERIN (UNII: PDC6A3C0OX) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) PARAFFIN (UNII: I9O0E3H2ZE) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) BARIUM SULFATE (UNII: 25BB7EKE2E) TREHALOSE (UNII: B8WCK70T7I) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) DIGLYCINE (UNII: 10525P22U0) PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PALMITIC ACID (UNII: 2V16EO95H1) RICE BRAN (UNII: R60QEP13IC) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) EDETATE TRISODIUM (UNII: 420IP921MB) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) ALUMINUM OXIDE (UNII: LMI26O6933) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ALCOHOL (UNII: 3K9958V90M) ISOPROPYL ALCOHOL (UNII: ND2M416302) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) PETROLATUM (UNII: 4T6H12BN9U) DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42) THEANINE (UNII: 8021PR16QO) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) METHICONE (20 CST) (UNII: 6777U11MKT) TETRADECENE (UNII: FW23481S7S) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) PHENOXYETHANOL (UNII: HIE492ZZ3T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-286-10 1 in 1 CARTON 02/01/2017 1 9 g 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 not final part352 02/01/2017 CLE DE PEAU BEAUTE RADIANT FOUNDATION BEIGE
octinoxate stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-287 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 306 mg in 9 g Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) GLYCERIN (UNII: PDC6A3C0OX) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) PARAFFIN (UNII: I9O0E3H2ZE) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) BARIUM SULFATE (UNII: 25BB7EKE2E) TREHALOSE (UNII: B8WCK70T7I) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) DIGLYCINE (UNII: 10525P22U0) PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PALMITIC ACID (UNII: 2V16EO95H1) RICE BRAN (UNII: R60QEP13IC) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) EDETATE TRISODIUM (UNII: 420IP921MB) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) ALUMINUM OXIDE (UNII: LMI26O6933) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ALCOHOL (UNII: 3K9958V90M) ISOPROPYL ALCOHOL (UNII: ND2M416302) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) PETROLATUM (UNII: 4T6H12BN9U) DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42) THEANINE (UNII: 8021PR16QO) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) METHICONE (20 CST) (UNII: 6777U11MKT) TETRADECENE (UNII: FW23481S7S) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) PHENOXYETHANOL (UNII: HIE492ZZ3T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-287-10 1 in 1 CARTON 02/01/2017 1 9 g 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 not final part352 02/01/2017 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 manufacture(58411-284, 58411-285, 58411-286, 58411-287) , analysis(58411-284, 58411-285, 58411-286, 58411-287)
