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

----------

CLÉ DE PEAU BEAUTÉ PROTECTIVE FORTIFYING CREAM n

Drug Facts

Active ingredientsPurpose
AVOBENZONE 2.0%Sunscreen
OCTINOXATE 4.9%Sunscreen
OCTOCRYLENE 5.0%Sunscreen
OXYBENZONE 2.0%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 • CYCLOPENTASILOXANE • GLYCERIN • DIISOPROPYL SEBACATE • BUTYLENE GLYCOL • DIETHYLHEXYL SUCCINATE • SD ALCOHOL 40-B • TREHALOSE • PEG/PPG-14/7 DIMETHYL ETHER • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER • TOCOPHERYL ACETATE • PEG/PPG-17/4 DIMETHYL ETHER • PHYTOSTERYL MACADAMIATE • POLYQUATERNIUM-51 • 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 • BEHENETH-20 • PPG-17 • BEHENYL ALCOHOL • CARBOMER • POLYSORBATE 20 • TRIETHANOLAMINE • DISODIUM EDTA • STEARYL ALCOHOL • HYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHER • THEANINE • SODIUM CITRATE • ALCOHOL • SODIUM METAPHOSPHATE • CITRIC ACID • BHT • TOCOPHEROL • PHENOXYETHANOL • METHYLPARABEN • BENZOIC ACID • FRAGRANCE • MICA • TITANIUM DIOXIDE • IRON OXIDES •

Other information

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 50 mL Container Carton

clé de peau
BEAUTÉ

PROTECTIVE FORTIFYING CREAM n
BROAD SPECTRUM
SPF 22
SUNSCREEN

50mL NET WT. 1.8 OZ.

PRINCIPAL DISPLAY PANEL - 50 mL Container Carton
CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING N 
avobenzone, octinoxate, octocrylene, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-455
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1030 mg  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2524 mg  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2575 mg  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE1030 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
TREHALOSE (UNII: B8WCK70T7I)  
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K)  
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)  
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
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)  
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)  
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)  
BEHENETH-20 (UNII: BJ4GP2IFLN)  
PPG-17 (UNII: OV0Q322E0U)  
DOCOSANOL (UNII: 9G1OE216XY)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
TROLAMINE (UNII: 9O3K93S3TK)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
THEANINE (UNII: 8021PR16QO)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
ALCOHOL (UNII: 3K9958V90M)  
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-455-501 in 1 CARTON02/01/2019
150 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(58411-455) , ANALYSIS(58411-455)

Revised: 10/2018
Document Id: 5bc01e07-7b00-48bd-8988-d50df503b787
Set id: 46133b89-9f93-4342-adaa-3e10f5193aba
Version: 1
Effective Time: 20181029
 
SHISEIDO AMERICAS CORPORATION