CLE DE PEAU BEAUTE GENTLE PROTECTIVE I- avobenzone, octinoxate, octocrylene, and oxybenzone emulsion 
SHISEIDO CO., LTD.

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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CLE DE PEAU BEAUTE GENTLE PROTECTIVE I

Drug Facts

ACTIVE INGREDIENTS:Purpose
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, ALCOHOL, DIPROPYLENE GLYCOL, GLYCERIN, HYDROGENATED POLYDECENE, XYLITOL, DIMETHICONE, ISODODECANE, TRIETHYLHEXANOIN, PEG-5 GLYCERYL STEARATE, ISOSTEARIC ACID, SILICA, DIPHENYLSILOXY PHENYL TRIMETHICONE, XANTHAN GUM, PEG/PPG-17/4 DIMETHYL ETHER, PHYTOSTERYL MACADAMIATE, TOCOPHERYL ACETATE, GLYCYL GLYCINE, CRATAEGUS MONOGYNA FLOWER EXTRACT, SERINE, 2-O-ETHYL ASCORBIC ACID, SODIUM ACETYLATED HYALURONATE, POLYQUATERNIUM-51, SAXIFRAGA SARMENTOSA EXTRACT, UNCARIA GAMBIR EXTRACT, GINKGO BILOBA LEAF EXTRACT, ROSA ROXBURGHII FRUIT EXTRACT, HYDROLYZED CONCHIOLIN PROTEIN, HYPERICUM ERECTUM EXTRACT, HYDROLYZED SILK, BUPLEURUM FALCATUM ROOT EXTRACT, COIX LACRYMA-JOBI MA-YUEN SEED EXTRACT, PPG-17, TRIETHANOLAMINE, GLYCERYL STEARATE SE, BEHENIC ACID, STEARIC ACID, BEHENYL ALCOHOL, BATYL ALCOHOL, PEG-30 SOY STEROL, CARBOMER, DISODIUM EDTA, CELLULOSE GUM, SODIUM METAPHOSPHATE, BUTYLENE GLYCOL, BHT, SODIUM MAGNESIUM SILICATE, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE,

Other information

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

Questions or comments?

Call toll free 1-800-906-7503

Manufactured by
SHISEIDO CO., LTD.
7-5-5 GINZA TOKYO

PRINCIPAL DISPLAY PANEL - 125mL Bottle Carton

clé de peau
BEAUTÉ

gentle protective emulsion

BROAD SPECTRUM
SPF 22
SUNSCREEN

125mL 4.2 FL. OZ.

Principal Display Panel - 125mL Bottle Carton
CLE DE PEAU BEAUTE GENTLE PROTECTIVE I 
avobenzone, octinoxate, octocrylene, and oxybenzone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-462
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3163 mg  in 126.5 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE9361 mg  in 126.5 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2530 mg  in 126.5 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE1265 mg  in 126.5 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
ISODODECANE (UNII: A8289P68Y2)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
XYLITOL (UNII: VCQ006KQ1E)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
PPG-17 (UNII: OV0Q322E0U)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
BEHENIC ACID (UNII: H390488X0A)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DOCOSANOL (UNII: 9G1OE216XY)  
BATILOL (UNII: 39YR661C4U)  
XANTHAN GUM (UNII: TTV12P4NEE)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
DIGLYCINE (UNII: 10525P22U0)  
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CRATAEGUS MONOGYNA FLOWER (UNII: NT52AMP29J)  
SERINE (UNII: 452VLY9402)  
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 4:1) (UNII: X8Q92E1CPM)  
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)  
GINKGO (UNII: 19FUJ2C58T)  
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)  
COIX LACRYMA-JOBI VAR. MA-YUEN SEED (UNII: 8DW238I7ZI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52685-462-101 in 1 CARTON10/01/201205/31/2018
1126.5 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35210/01/201205/31/2018
Labeler - SHISEIDO CO., LTD. (690536453)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO CO., LTD.695087684MANUFACTURE(52685-462) , ANALYSIS(52685-462)

Revised: 9/2023
 
SHISEIDO CO., LTD.