CLE DE PEAU BEAUTE UV PROTECTIVE N- avobenzone, homosalate, octisalate, and octocrylene cream 
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 CREAM N

Drug Facts

Active ingredientsPurpose
AVOBENZONE 2.3%Sunscreen
HOMOSALATE 10.0%Sunscreen
OCTISALATE 5.0%Sunscreen
OCTOCRYLENE 5.0%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.

Directions

For sunscreen use:

Inactive ingredients

WATER▪BUTYLENE GLYCOL▪GLYCERIN▪SILICA▪GLYCERYL DIISOSTEARATE▪ALCOHOL DENAT.▪CAPRYLYL METHICONE▪BEHENYL ALCOHOL▪C30-45 ALKYL METHICONE▪DIPROPYLENE GLYCOL▪DIMETHICONE▪AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER▪XANTHAN GUM▪TREHALOSE▪TOCOPHERYL ACETATE▪2-O-ETHYL ASCORBIC ACID▪SCUTELLARIA BAICALENSIS ROOT EXTRACT▪GLYCINE▪PEG/PPG-14/7 DIMETHYL ETHER▪THYMUS SERPYLLUM EXTRACT▪GARCINIA MANGOSTANA BARK EXTRACT▪PANAX GINSENG ROOT EXTRACT▪FAGUS SYLVATICA BUD EXTRACT▪AMINOETHANESULFINIC ACID▪BUPLEURUM FALCATUM ROOT EXTRACT▪ANGELICA ACUTILOBA ROOT EXTRACT▪HYDROLYZED CONCHIOLIN PROTEIN▪HYDROLYZED SILK▪PERILLA OCYMOIDES LEAF EXTRACT▪POLYQUATERNIUM-51▪CRATAEGUS MONOGYNA FLOWER EXTRACT▪SAXIFRAGA SARMENTOSA EXTRACT▪GINKGO BILOBA LEAF EXTRACT▪MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT▪BEHENETH-20▪C30-45 OLEFIN▪STEARYL ALCOHOL▪DISODIUM EDTA▪CARBOMER▪POTASSIUM HYDROXIDE▪TOCOPHEROL▪SODIUM METAPHOSPHATE▪BHT▪ALCOHOL▪SODIUM METABISULFITE▪THEANINE▪SYZYGIUM JAMBOS LEAF EXTRACT▪PHENOXYETHANOL▪FRAGRANCE▪IRON OXIDES▪TITANIUM DIOXIDE▪MICA▪

Other information

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PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

clé de peau
BEAUTÉ

UV PROTECTIVE CREAM n

50+

BROAD SPECTRUM
SPF 50+
SUNSCREEN

50mL NET WT. 1.8 OZ.

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
CLE DE PEAU BEAUTE UV PROTECTIVE N 
avobenzone, homosalate, octisalate, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-855
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.2167 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5.29 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.645 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.645 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC)  
ALCOHOL (UNII: 3K9958V90M)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
DOCOSANOL (UNII: 9G1OE216XY)  
C30-45 ALKYL METHICONE (UNII: NFX970DSI2)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TREHALOSE (UNII: B8WCK70T7I)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
GLYCINE (UNII: TE7660XO1C)  
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)  
GARCINIA MANGOSTANA BARK (UNII: N6A4WY566I)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
HYPOTAURINE (UNII: 5L08GE4332)  
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)  
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 4:1) (UNII: X8Q92E1CPM)  
CRATAEGUS MONOGYNA FLOWER (UNII: NT52AMP29J)  
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)  
GINKGO (UNII: 19FUJ2C58T)  
MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
BEHENETH-20 (UNII: BJ4GP2IFLN)  
C30-45 OLEFIN (UNII: 6DWD51M0O8)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
THEANINE (UNII: 8021PR16QO)  
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-855-601 in 1 CARTON08/01/2022
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/01/2022
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Revised: 1/2023
Document Id: 80eef7cf-cd3c-4253-8334-67317c805453
Set id: 6a708c60-6797-47f6-8839-065bd9b7f67d
Version: 1
Effective Time: 20230130
 
SHISEIDO AMERICAS CORPORATION