CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING N- avobenzone, octinoxate, octocrylene, and oxybenzone 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.

----------

CLÉ DE PEAU BEAUTÉ PROTECTIVE FORTIFYING EMULSION n

Drug Facts

Active ingredientsPurpose
AVOBENZONE 2.5%Sunscreen
OCTINOXATE 7.4%Sunscreen
OCTOCRYLENE 2.0%Sunscreen
OXYBENZONE 1.0%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 • DIPROPYLENE GLYCOL • SD ALCOHOL 40-B • GLYCERIN • HYDROGENATED POLYDECENE • XYLITOL • DIMETHICONE • ISODODECANE • PEG/PPG-14/7 DIMETHYL ETHER • PEG-5 GLYCERYL STEARATE • SILICA • ISOSTEARIC ACID • DIPHENYLSILOXY PHENYL TRIMETHICONE • XANTHAN GUM • TREHALOSE • TOCOPHERYL ACETATE • PEG/PPG-17/4 DIMETHYL ETHER • PHYTOSTERYL MACADAMIATE • GINKGO BILOBA LEAF EXTRACT • ANGELICA ACUTILOBA ROOT EXTRACT • PAEONIA ALBIFLORA ROOT EXTRACT • CRATAEGUS MONOGYNA FLOWER EXTRACT • PANAX GINSENG ROOT EXTRACT • GLYCINE • ONONIS SPINOSA ROOT EXTRACT • HYDROLYZED SILK • ROSA CANINA FRUIT EXTRACT • ZANTHOXYLUM PIPERITUM PEEL EXTRACT • HIBISCUS ESCULENTUS FRUIT EXTRACT • FAGUS SYLVATICA BUD EXTRACT • SODIUM ACETYLATED HYALURONATE • PERILLA OCYMOIDES LEAF EXTRACT • ROSA ROXBURGHII FRUIT EXTRACT • HYDROLYZED CONCHIOLIN PROTEIN • ISODONIS JAPONICUS LEAF/STALK EXTRACT • BUPLEURUM FALCATUM ROOT EXTRACT • PPG-17 • TRIETHANOLAMINE • GLYCERYL STEARATE SE • BEHENYL ALCOHOL • BEHENIC ACID • STEARIC ACID • BUTYLENE GLYCOL • BATYL ALCOHOL • THEANINE • PEG-30 PHYTOSTEROL • CARBOMER • DISODIUM EDTA • ALCOHOL • CELLULOSE GUM • SODIUM METAPHOSPHATE • BHT • TOCOPHEROL • METHYLPARABEN • ETHYLPARABEN • PHENOXYETHANOL • BENZOIC ACID • FRAGRANCE • TITANIUM DIOXIDE • MICA • IRON OXIDES •

Other information

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

clé de peau
BEAUTÉ

PROTECTIVE FORTIFYING
EMULSION n

BROAD SPECTRUM
SPF 22
SUNSCREEN

30 mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING N 
avobenzone, octinoxate, octocrylene, and oxybenzone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-561
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.93 g  in 30 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.7528 g  in 30 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.744 g  in 30 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.372 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
XYLITOL (UNII: VCQ006KQ1E)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISODODECANE (UNII: A8289P68Y2)  
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TREHALOSE (UNII: B8WCK70T7I)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K)  
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)  
GINKGO (UNII: 19FUJ2C58T)  
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
CRATAEGUS MONOGYNA FLOWER (UNII: NT52AMP29J)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
GLYCINE (UNII: TE7660XO1C)  
ONONIS SPINOSA ROOT (UNII: FD2FMC53M1)  
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)  
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)  
FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)  
PPG-17 (UNII: OV0Q322E0U)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
DOCOSANOL (UNII: 9G1OE216XY)  
BEHENIC ACID (UNII: H390488X0A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BATILOL (UNII: 39YR661C4U)  
THEANINE (UNII: 8021PR16QO)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALCOHOL (UNII: 3K9958V90M)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ETHYLPARABEN (UNII: 14255EXE39)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-561-101 in 1 CARTON03/01/2020
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35203/01/2020
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Revised: 4/2020
Document Id: 8594bee0-f67e-45ac-924d-2a5cd4ba502a
Set id: 9d247235-672a-4550-868f-7682c7def4a7
Version: 1
Effective Time: 20200417
 
SHISEIDO AMERICAS CORPORATION