CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER- ensulizole and octinoxate cream 
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 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.

PRINCIPAL DISPLAY PANEL - 20mL Bottle Carton
CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER 
ensulizole and octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-380
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42) Ensulizole430 mg  in 21.52 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate1054 mg  in 21.52 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DOCOSANOL (UNII: 9G1OE216XY)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TROLAMINE (UNII: 9O3K93S3TK)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
LAURYL BETAINE (UNII: Y4P927Q133)  
ALCOHOL (UNII: 3K9958V90M)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52685-380-101 in 1 CARTON11/01/200912/31/2020
121.52 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 FINALpart35211/01/200912/31/2020
Labeler - SHISEIDO CO., LTD. (690536453)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO CO., LTD.695087684MANUFACTURE(52685-380) , ANALYSIS(52685-380)

Revised: 9/2023
 
SHISEIDO CO., LTD.