← See all CLE DE PEAU BEAUTE REFRESHING PROTECTIVE I brands

CLE DE PEAU BEAUTE REFRESHING PROTECTIVE I

Dosage form: cream
Ingredients: Ensulizole 1.90875g in 127.25g, Octinoxate 6.23525g in 127.25g, Octocrylene 3.8175g in 127.25g, Oxybenzone 1.2725g in 127.25g
Labeler: SHISEIDO CO., LTD.
NDC Code: 52685-346

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.

cle de peau BEAUTE REFRESHING PROTECTIVE EMULSION I

Drug Facts

Active ingredientsPurpose
ENSULIZOLE 1.5%Sunscreen
OCTINOXATE 4.9%Sunscreen
OCTOCRYLENE 5.0%Sunscreen
OXYBENZONE 1.0%Sunscreen

Uses
  • helps prevent sunburn
  • higher SPF gives more sunburn protection

Warnings

For external use only

When using this product
  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if
  • rash or irritation develops and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • apply evenly before sun exposure and as needed.
  • children under 6 months of age: ask a doctor.

Inactive ingredients

WATER, ALCOHOL, DIPROPYLENE GLYCOL, GLYCERIN, XYLITOL, DIMETHICONE, HYDROGENATED POLYDECENE, TRIETHANOLAMINE, PPG-8 CETETH-20, PEG/PPG-17/4 DIMETHYL ETHER, PHYTOSTERYL MACADAMIATE, XANTHAN GUM, TOCOPHERYL ACETATE, CRATAEGUS MONOGINA FLOWER EXTRACT, SERINE, 2-O-ETHYL ASCORBIC ACID, GLYCYL GLYCINE, SODIUM ACETYLATED HYALURONATE, POLYQUATERNIUM-51, SAXIFRAGA SARMENTOSA EXTRACT, UNCARIA GAMBIR EXTRACT, GINKGO BILOBA LEAF EXTRACT, PAEONIA SUFFRUTICOSA ROOT EXTRACT, ROSA ROXBURGHII FRUIT EXTRACT, HYDROLYZED CONCHIOLIN PROTEIN, HYPERICUM ERECTUM EXTRACT, HYDROLYZED SILK, BUPLEURUM FALCATUM ROOT EXTRACT, COIX LACRYMA-JOBI (JOB'S TEARS) SEED EXTRACT, CARBOMER, ISOSTEARIC ACID, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, DISODIUM EDTA, BUTYLENE GLYCOL, BHT, SODIUM METABISULFITE, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE

Questions?

1-800-906-7503

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

PRINCIPAL DISPLAY PANEL - 125mL Carton

clé de peau
BEAUTÉ

refreshing protective emulsion

SPF 20
sunscreen

125mL 4.2 FL. OZ.

CLE DE PEAU BEAUTE REFRESHING PROTECTIVE I 
ensulizole, octinoxate, octocrylene, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-346
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ensulizole (Ensulizole) Ensulizole1.90875 g  in 127.25 g
Octinoxate (Octinoxate) Octinoxate6.23525 g  in 127.25 g
Octocrylene (Octocrylene) Octocrylene3.8175 g  in 127.25 g
Oxybenzone (Oxybenzone) Oxybenzone1.2725 g  in 127.25 g
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
DIPROPYLENE GLYCOL 
GLYCERIN 
XYLITOL 
DIMETHICONE 
TROLAMINE 
XANTHAN GUM 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
SERINE 
DIGLYCINE 
SAXIFRAGA STOLONIFERA LEAF 
GINKGO 
PAEONIA SUFFRUTICOSA ROOT 
HYPERICUM ERECTUM FLOWERING TOP 
BUPLEURUM FALCATUM ROOT 
COIX LACRYMA-JOBI SEED 
ISOSTEARIC ACID 
EDETATE DISODIUM 
BUTYLENE GLYCOL 
BUTYLATED HYDROXYTOLUENE 
SODIUM METABISULFITE 
ALPHA-TOCOPHEROL 
PHENOXYETHANOL 
Packaging
#Item CodePackage Description
1NDC:52685-346-101 BOTTLE (BOTTLE) in 1 CARTON
1127.25 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/2011
Labeler - SHISEIDO CO., LTD. (690536453)
Establishment
NameAddressID/FEIOperations
SHISEIDO CO., LTD.695087684MANUFACTURE(52685-346), ANALYSIS(52685-346)

Revised: 04/2012
 
SHISEIDO CO., LTD.

← See all CLE DE PEAU BEAUTE REFRESHING PROTECTIVE I brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web5)