Label: CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O70- octinoxate and titanium dioxide emulsion
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O80- octinoxate and titanium dioxide emulsion
- NDC Code(s): 58411-477-20, 58411-478-20
- 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 11, 2019
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
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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
- Reapply at least every 2 hours
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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
DIMETHICONE▪WATER▪BUTYLENE GLYCOL▪GLYCERIN▪PEG-10 DIMETHICONE▪CYCLOHEXASILOXANE▪BIS-BUTYLDIMETHICONE POLYGLYCERYL-3▪POLYMETHYLSILSESQUIOXANE▪ERYTHRITOL▪XYLITOL▪BARIUM SULFATE▪DIPHENYLSILOXY PHENYL TRIMETHICONE▪DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER▪POLYQUATERNIUM-51▪SODIUM ACETYLATED HYALURONATE▪ROSA ROXBURGHII FRUIT EXTRACT▪HYDROLYZED CONCHIOLIN PROTEIN▪HYDROLYZED SILK▪SYNTHETIC FLUORPHLOGOPITE▪DIMETHICONE/PEG-10/15 CROSSPOLYMER▪DISTEARDIMONIUM HECTORITE▪SORBITAN SESQUIISOSTEARATE▪ALUMINUM HYDROXIDE▪STEARIC ACID▪DISODIUM EDTA▪POLYSILICONE-2▪ALUMINA▪TRIETHOXYCAPRYLYLSILANE▪TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE▪TOCOPHEROL▪DIPROPYLENE GLYCOL▪SILICA▪VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER▪BHT▪ALCOHOL▪PHENOXYETHANOL▪FRAGRANCE▪IRON OXIDES▪TITANIUM DIOXIDE▪MICA▪
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - 58411-477
- PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - 58411-478
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INGREDIENTS AND APPEARANCE
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O70
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-477 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.6611 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.8475 mg in 30 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) CYCLOMETHICONE 6 (UNII: XHK3U310BA) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) BARIUM SULFATE (UNII: 25BB7EKE2E) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) EDETATE DISODIUM (UNII: 7FLD91C86K) ALUMINUM OXIDE (UNII: LMI26O6933) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DIPROPYLENE GLYCOL (UNII: E107L85C40) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALCOHOL (UNII: 3K9958V90M) 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:58411-477-20 1 in 1 CARTON 05/01/2019 1 30 mL 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 05/01/2019 CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O80
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-478 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.6611 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.8475 mg in 30 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) CYCLOMETHICONE 6 (UNII: XHK3U310BA) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) BARIUM SULFATE (UNII: 25BB7EKE2E) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) EDETATE DISODIUM (UNII: 7FLD91C86K) ALUMINUM OXIDE (UNII: LMI26O6933) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DIPROPYLENE GLYCOL (UNII: E107L85C40) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALCOHOL (UNII: 3K9958V90M) 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:58411-478-20 1 in 1 CARTON 05/01/2019 1 30 mL 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 05/01/2019 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICAS INC. 782677132 MANUFACTURE(58411-477, 58411-478) , ANALYSIS(58411-477, 58411-478)