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CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER

Dosage form: cream
Ingredients: Ensulizole 430mg in 21.52g, Octinoxate 1054mg in 21.52g
Labeler: SHISEIDO CO., LTD.
NDC Code: 52685-380

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 SYNACTIF DAYTIME MOISTURIZER

Drug Facts

Active ingredientsPurpose
ENSULIZOLE 2.0%Sunscreen
OCTINOXATE 4.9%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 generously before sun exposure and as needed.
  • apply and reapply as directed to avoid lowering protection.
  • apply to all skin exposed to the sun.
  • children under 6 months of age: ask a doctor

Inactive ingredients

WATER, GLYCERIN, BUTYLENE GLYCOL, CYCLOMETHICONE, DIPROPYLENE GLYCOL, SILICA, DIMETHICONE, TRIETHYLHEXANOIN, DIPHENYLSILOXY PHENYL TRIMETHICONE, BEHENYL ALCOHOL, BEHENETH-20, TRIETHANOLAMINE, METHYL AMINOMETHYLCYCLOHEXANE CARBOXAMIDE HCl, XANTHAN GUM, TOCOPHERYL ACETATE, SODIUM HYALURONATE, SODIUM ACETYLATED HYALURONATE, LAURYL BETAINE, BUPLEURUM FALCATUM ROOT EXTRACT, UNCARIA GAMBIR EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, STEARYL ALCOHOL, SODIUM METAPHOSPHATE, CELLULOSE GUM, TRISODIUM EDTA, ALUMINUM HYDROXIDE, ISOSTEARIC ACID, BHT, ALCOHOL, TOCOPHEROL, PHENOXYETHANOL, SODIUM BENZOATE, FRAGRANCE, TITANIUM DIOXIDE, IRON OXIDES

Questions?

1-800-906-7503

Distributed by
SHISEIDO COSMETICS (AMERICA) LTD.
NEW YORK, NY 10022

PRINCIPAL DISPLAY PANEL - 20mL Bottle Carton

SYNACTIF

Daytime moisturizer
SPF 17 sunscreen

20mL NET WT. .75 OZ.

CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER 
ensulizole and octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-380
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ensulizole (Ensulizole) Ensulizole430 mg  in 21.52 g
Octinoxate (Octinoxate) Octinoxate1054 mg  in 21.52 g
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
BUTYLENE GLYCOL 
CYCLOMETHICONE 
DIPROPYLENE GLYCOL 
SILICON DIOXIDE 
TRIETHYLHEXANOIN 
DIMETHICONE 
DOCOSANOL 
TITANIUM DIOXIDE 
TROLAMINE 
STEARYL ALCOHOL 
PHENOXYETHANOL 
XANTHAN GUM 
SODIUM POLYMETAPHOSPHATE 
CARBOXYMETHYLCELLULOSE SODIUM 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
EDETATE TRISODIUM 
ALUMINUM HYDROXIDE 
HYALURONATE SODIUM 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
ISOSTEARIC ACID 
BUTYLATED HYDROXYTOLUENE 
LAURYL BETAINE 
ALCOHOL 
.ALPHA.-TOCOPHEROL 
BUPLEURUM FALCATUM ROOT 
GREEN TEA LEAF 
SODIUM BENZOATE 
Packaging
#Item CodePackage Description
1NDC:52685-380-101 BOTTLE (BOTTLE) in 1 CARTON
121.52 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35211/01/2009
Labeler - SHISEIDO CO., LTD. (690536453)
Establishment
NameAddressID/FEIOperations
SHISEIDO CO., LTD.695087684MANUFACTURE(52685-380), ANALYSIS(52685-380)

Revised: 04/2012
 
SHISEIDO CO., LTD.

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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.

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