CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING- avobenzone, octinoxate, octocrylene, and oxybenzone emulsion 
SHISEIDO AMERICAS CORPORATION

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CLÉ DE PEAU BEAUTÉ PROTECTIVE FORTIFYING

EMULSION

Drug Facts

Active ingredientsPurpose
AVOBENZONE 2.5%Sunscreen
OCTINOXATE 7.4%Sunscreen
OCTOCRYLENE 2.0%Sunscreen
OXYBENZONE 1.0%Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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:

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Inactive Ingredients

WATER (AQUA/EAU) • 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 • TREHALOSE • DIPHENYLSILOXY PHENYL TRIMETHICONE • XANTHAN GUM • TOCOPHERYL ACETATE • PEG/PPG-17/4 DIMETHYL ETHER • PHYTOSTERYL MACADAMIATE • POLYQUATERNIUM-51 • SODIUM ACETYLATED HYALURONATE • GINKGO BILOBA LEAF EXTRACT • PAEONIA ALBIFLORA ROOT EXTRACT • CRATAEGUS MONOGYNA FLOWER EXTRACT • CAFFEINE • SERINE • HYDROLYZED SILK • 2-O-ETHYL ASCORBIC ACID • BUPLEURUM FALCATUM ROOT EXTRACT • UNCARIA GAMBIR EXTRACT • ROSA ROXBURGHII FRUIT EXTRACT • HYDROLYZED CONCHIOLIN PROTEIN • PPG-17 • TRIETHANOLAMINE • GLYCERYL STEARATE SE • BEHENYL ALCOHOL • BEHENIC ACID • STEARIC ACID • BATYL ALCOHOL • PEG-30 SOY STEROL • THEANINE • BUTYLENE GLYCOL • CARBOMER • DISODIUM EDTA • CELLULOSE GUM • SODIUM METAPHOSPHATE • BHT • ALCOHOL • TOCOPHEROL • METHYLPARABEN • ETHYLPARABEN • PHENOXYETHANOL • BENZOIC ACID • FRAGRANCE (PARFUM) • TITANIUM DIOXIDE • MICA • IRON OXIDES •

Other information

  • protect this product in this container from excessive heat and direct sun.

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 125 mL Bottle Carton

clé de peau
BEAUTÉ

protective fortifying emulsion
BROAD SPECTRUM SPF 22
SUNSCREEN

DIN 02440814

125mL 4.2 FL. OZ.

PRINCIPAL DISPLAY PANEL - 125 mL Bottle Carton
CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING 
avobenzone, octinoxate, octocrylene, and oxybenzone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-259
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
BENZOIC ACID (UNII: 8SKN0B0MIM)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
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)  
TREHALOSE (UNII: B8WCK70T7I)  
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
XANTHAN GUM (UNII: TTV12P4NEE)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K)  
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
GINKGO (UNII: 19FUJ2C58T)  
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
CRATAEGUS MONOGYNA FLOWER (UNII: NT52AMP29J)  
CAFFEINE (UNII: 3G6A5W338E)  
SERINE (UNII: 452VLY9402)  
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)  
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
PPG-17 (UNII: OV0Q322E0U)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
DOCOSANOL (UNII: 9G1OE216XY)  
BEHENIC ACID (UNII: H390488X0A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BATILOL (UNII: 39YR661C4U)  
THEANINE (UNII: 8021PR16QO)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ALCOHOL (UNII: 3K9958V90M)  
TOCOPHEROL (UNII: R0ZB2556P8)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ETHYLPARABEN (UNII: 14255EXE39)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-259-101 in 1 CARTON02/01/201609/01/2019
1125 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM02002/01/201609/01/2019
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICA INC.782677132manufacture(58411-259) , analysis(58411-259)

Revised: 10/2023
Document Id: d2e2a380-49f0-44a5-9f69-faeafd27d745
Set id: 00eba4f9-0214-4417-b14d-fbfc1713fe53
Version: 3
Effective Time: 20231020
 
SHISEIDO AMERICAS CORPORATION