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 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?

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PRINCIPAL DISPLAY PANEL - 12 mL Bottle Carton

clé de peau
BEAUTÉ

PROTECTIVE FORTIFYING CREAM n
BROAD SPECTRUM
SPF 22
SUNSCREEN

12mL NET WT. .43 OZ.

PRINCIPAL DISPLAY PANEL - 12 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:58411-562
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.2472 g  in 12 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.60564 g  in 12 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.618 g  in 12 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.2472 g  in 12 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)  
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)  
BEHENETH-20 (UNII: BJ4GP2IFLN)  
PPG-17 (UNII: OV0Q322E0U)  
DOCOSANOL (UNII: 9G1OE216XY)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (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:58411-562-101 in 1 CARTON03/01/2020
112 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: 78fe2dc7-c7b5-46f1-9d4b-2e9ab9ebc75d
Set id: 23bb4225-bfb5-47e2-80fe-733761ba4069
Version: 1
Effective Time: 20200417
 
SHISEIDO AMERICAS CORPORATION