CLE DE PEAU BEAUTE SHEER FLUID VEIL- avobenzone, octinoxate, 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 SHEER FLUID VEIL

Drug Facts

Active ingredientsPurpose
AVOBENZONE 2.5%Sunscreen
OCTINOXATE 7.4%Sunscreen
OCTOCRYLENE 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∙SD ALCOHOL 40-B∙BUTYLENE GLYCOL∙XYLITOL∙DIMETHICONE∙TALC∙GLYCERIN∙POLYMETHYL METHACRYLATE∙PEG/PPG-19/19 DIMETHICONE∙HYDROGENATED POLYISOBUTENE∙XANTHAN GUM∙ERYTHRITOL∙SODIUM ACETYLATED HYALURONATE∙ROSA ROXBURGHII FRUIT EXTRACT∙DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER∙HYDROLYZED CONCHIOLIN PROTEIN∙HYDROLYZED SILK∙PPG-17∙DISODIUM EDTA∙PEG-60 GLYCERYL ISOSTEARATE∙TRIETHANOLAMINE∙CARBOMER∙ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER∙SODIUM METAPHOSPHATE∙BHT∙TOCOPHEROL∙SODIUM METABISULFITE∙POLYMETHYLSILSESQUIOXANE∙ALCOHOL∙FRAGRANCE∙IRON OXIDES∙MICA∙TITANIUM DIOXIDE∙

Other information

Questions or comments?

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PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

clé de peau
BEAUTÉ

sheer fluid veil

BROAD SPECTRUM
SPF 21
SUNSCREEN

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton
CLE DE PEAU BEAUTE SHEER FLUID VEIL 
avobenzone, octinoxate, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-206
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE771 mg  in 30 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2282 mg  in 30 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE617 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
XYLITOL (UNII: VCQ006KQ1E)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TALC (UNII: 7SEV7J4R1U)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ERYTHRITOL (UNII: RA96B954X6)  
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
PPG-17 (UNII: OV0Q322E0U)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PEG-60 GLYCERYL ISOSTEARATE (UNII: WQP0973914)  
TROLAMINE (UNII: 9O3K93S3TK)  
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
ALCOHOL (UNII: 3K9958V90M)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-206-101 in 1 CARTON09/01/2014
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 not finalpart35209/01/2014
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICA INC.782677132manufacture(58411-206) , analysis(58411-206)

Revised: 12/2018
Document Id: 7cf319bf-a1bb-60d9-e053-2991aa0a94a9
Set id: 088da297-218f-4ee6-9def-34a840f2a6a9
Version: 2
Effective Time: 20181213
 
SHISEIDO AMERICAS CORPORATION