CLE DE PEAU BEAUTE UV PROTECTIVE FOR BODY N- ensulizole, octisalate, octocrylene, and zinc oxide emulsion 
SHISEIDO AMERICAS CORPORATION

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.

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clé de peau BEAUTÉ UV PROTECTIVE EMULSION FOR BODY n

Drug Facts

Active ingredientsPurpose
ENSULIZOLE 2.0%Sunscreen
OCTISALATE 5.0%Sunscreen
OCTOCRYLENE 5.0%Sunscreen
ZINC OXIDE 19.4%Sunscreen

Uses

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Flammable: Do not use near heat, flame, or while smoking.

Directions

For sunscreen use:

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?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 100 mL Container Carton

clé de peau
BEAUTÉ

UV PROTECTIVE EMULSION
FOR BODY n

60+
BROAD SPECTRUM
SPF 60+
WATER RESISTANT
(80 MINUTES)
SUNSCREEN

100mL 3.3 FL. OZ.

PRINCIPAL DISPLAY PANEL - 100 mL Container Carton
CLE DE PEAU BEAUTE UV PROTECTIVE FOR BODY N 
ensulizole, octisalate, octocrylene, and zinc oxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-858
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE2.384 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.96 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5.96 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE23.1248 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-858-401 in 1 CARTON01/01/2024
1100 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2024
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Revised: 5/2023
Document Id: 4c02d40e-3497-458f-9c28-def86ef64250
Set id: a45d085c-d10c-4947-ad9a-ded5483e1697
Version: 1
Effective Time: 20230530
 
SHISEIDO AMERICAS CORPORATION