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.

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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 - 125 mL Container Carton

clé de peau
BEAUTÉ

PROTECTIVE FORTIFYING
EMULSON n

BROAD SPECTRUM
SPF 22
SUNSCREEN

125mL 4.2 FL. OZ.

PRINCIPAL DISPLAY PANEL - 125 mL Container Carton
CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING N 
avobenzone, octinoxate, octocrylene, and oxybenzone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-454
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3200 mg  in 125 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE9472 mg  in 125 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2560 mg  in 125 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE1280 mg  in 125 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGENATED POLYDECENE (550 MW) (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)  
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
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)  
CARBOXYPOLYMETHYLENE (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:58411-454-101 in 1 CARTON02/01/2019
1125 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/01/2019
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICA INC.782677132MANUFACTURE(58411-454) , ANALYSIS(58411-454)

Revised: 10/2018
Document Id: eb56f3cf-531d-4022-ba6e-489d8d0e7d3d
Set id: 207e2035-5f31-4745-a801-b386b040b738
Version: 1
Effective Time: 20181029
 
SHISEIDO AMERICAS CORPORATION