Label: CLE DE PEAU BEAUTE UV PROTECTIVE FOR BODY N- ensulizole, octisalate, octocrylene, and zinc oxide emulsion
- NDC Code(s): 58411-858-40
- 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 May 30, 2023
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- 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
- reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- 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
WATER∙ DIMETHICONE∙ DIISOPROPYL SEBACATE ∙GLYCERIN∙ ALCOHOL DENAT. • TRISILOXANE∙ PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE ∙SILICA∙ ISOPROPYL MYRISTATE∙ DIPHENYLSILOXY PHENYL TRIMETHICONE • ISODODECANE • TRIMETHYLSILOXYSILICATE • TRIETHANOLAM IN E • DEXTRIN PALMITATE • TREHALOSE • MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT∙ RUBUS SUAVISSIMUS (RASPBERRY) LEAF EXTRACT∙ GLYCINE∙ PEG/PPG-14/7 DIMETHYL ETHER∙ HYDRANGEA SERRATA LEAF EXTRACT∙ THYMUS SERPYLLUM EXTRACT∙ SODIUM ACETYLATED HYALURONATE ∙AMINOETHANESULFINIC ACID∙SODIUM HYALURONATE∙ TOCOPHERYL ACETATE-ANGELICA ACUTILOBA ROOT EXTRACT∙ HYDROLYZED CONCHIOLIN PROTEIN∙ HYDROLYZED SILK∙ PERILLA OCYMOIDES LEAF EXTRACT∙ POLYQUATERNIUM-51 • PANAX GINSENG ROOT EXTRACT∙SAXIFRAGA SARMENTOSA EXTRACT∙ GINKGO BILOBA LEAF EXTRACT-SCUTELLARIA BAICALENSIS ROOT EXTRACT∙ GARCINIA MANGOSTANA BARK EXTRACT∙ DISTEARDIMONIUM HECTORITE∙ HYDROGEN DIMETHICONE∙ ISOSTEARIC ACID∙ BUTYLENE GLYCOL∙DISODIUM EDTA∙ SORBITAN SESQUIISOSTEARATE∙ ALCOHOL∙ TOCOPHEROL∙ BHT • SODIUM M ETABISULFITE • SYNTHETIC FLUORPHLOGOPITE • THEANINE • SYZYGIUM JAMBOS LEAF EXTRACT∙ PHENOXYETHANOL ∙FRAGRANCE∙ RED 33∙YELLOW 5∙YELLOW 6∙
- Other Information
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL - 100 mL Container Carton
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INGREDIENTS AND APPEARANCE
CLE DE PEAU BEAUTE UV PROTECTIVE FOR BODY N
ensulizole, octisalate, octocrylene, and zinc oxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-858 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 2.384 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.96 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5.96 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 23.1248 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPOTAURINE (UNII: 5L08GE4332) GLYCERIN (UNII: PDC6A3C0OX) GLYCINE (UNII: TE7660XO1C) HYDRANGEA SERRATA LEAF (UNII: 2SFZ1X3QA9) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) THEANINE (UNII: 8021PR16QO) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) ISOSTEARIC ACID (UNII: X33R8U0062) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) GARCINIA MANGOSTANA BARK (UNII: N6A4WY566I) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) PHENOXYETHANOL (UNII: HIE492ZZ3T) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM METABISULFITE (UNII: 4VON5FNS3C) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) TROLAMINE (UNII: 9O3K93S3TK) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ISODODECANE (UNII: A8289P68Y2) DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3) TRISILOXANE (UNII: 9G1ZW13R0G) ALCOHOL (UNII: 3K9958V90M) D&C RED NO. 33 (UNII: 9DBA0SBB0L) TREHALOSE (UNII: B8WCK70T7I) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) DIMETHICONE (UNII: 92RU3N3Y1O) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) GINKGO (UNII: 19FUJ2C58T) MENTHA PIPERITA LEAF (UNII: A389O33LX6) ASIAN GINSENG (UNII: CUQ3A77YXI) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) EDETATE DISODIUM (UNII: 7FLD91C86K) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) RUBUS CHINGII VAR. SUAVISSIMUS LEAF (UNII: U5KPW4NCFM) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-858-40 1 in 1 CARTON 01/01/2024 1 100 mL in 1 CONTAINER; 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 01/01/2024 Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
