CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER N- avobenzone, octinoxate, and octocrylene cream 
SHISEIDO AMERICAS CORPORATION

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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CLÉ DE PEAU BEAUTÉ SYNACTIF DAYTIME MOISTURIZER n

Drug Facts

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

Uses

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

Other information

Inactive Ingredients

WATER∙XYLITOL∙DIPROPYLENE GLYCOL∙GLYCERIN∙SD ALCOHOL 40-B∙DIPHENYLSILOXY PHENYL TRIMETHICONE∙ISODODECANE∙SILICA∙TRIETHYLHEXANOIN∙HYDROGENATED POLYDECENE∙PPG-17∙DIMETHICONE∙METHYL AMINOMETHYLCYCLOHEXANE CARBOXAMIDE HCl∙XANTHAN GUM∙TOCOPHERYL ACETATE∙PEG/PPG-14/7 DIMETHYL ETHER∙PHYTOSTERYL MACADAMIATE∙GLYCYL GLYCINE∙SODIUM ACETYLATED HYALURONATE∙SODIUM HYALURONATE∙LAURYL BETAINE∙NUPHAR JAPONICUM ROOT EXTRACT∙BUPLEURUM FALCATUM ROOT EXTRACT∙GINKGO BILOBA LEAF EXTRACT∙CAMELLIA SINENSIS LEAF EXTRACT∙BEHENETH-20∙BEHENYL ALCOHOL∙HYDROGENATED PALM OIL∙ELAEIS GUINEENSIS (PALM) KERNEL OIL∙STEARYL ALCOHOL∙ELAEIS GUINEENSIS (PALM) OIL∙BUTYLENE GLYCOL∙ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER∙CARBOMER∙PEG-10 DIMETHICONE∙POTASSIUM HYDROXIDE∙CELLULOSE GUM∙SODIUM METAPHOSPHATE∙ALCOHOL∙DISODIUM EDTA∙BHT∙ISOSTEARIC ACID∙CINNAMOMUM CASSIA BARK EXTRACT∙TOCOPHEROL∙CITRIC ACID∙PHENOXYETHANOL∙SODIUM BENZOATE∙FRAGRANCE∙IRON OXIDES∙

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PRINCIPAL DISPLAY PANEL - 20 mL Bottle Carton

SYNACTIF

Daytime
moisturizer

BROAD SPECTRUM
SPF 19
SUNSCREEN

20mL .67 FL. OZ.

PRINCIPAL DISPLAY PANEL - 20 mL Bottle Carton
CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER N 
avobenzone, octinoxate, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-237
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE518 mg  in 20 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1532 mg  in 20 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE414 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
PALM OIL (UNII: 5QUO05548Z)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
ALCOHOL (UNII: 3K9958V90M)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
CHINESE CINNAMON (UNII: WS4CQ062KM)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
ISODODECANE (UNII: A8289P68Y2)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
PPG-17 (UNII: OV0Q322E0U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
METHYL AMINOMETHYLCYCLOHEXANE CARBOXAMIDE HYDROCHLORIDE (UNII: ZV6O50F5CP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
DIGLYCINE (UNII: 10525P22U0)  
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
LAURYL BETAINE (UNII: Y4P927Q133)  
NUPHAR JAPONICA ROOT (UNII: 3OPM78C6RQ)  
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)  
GINKGO (UNII: 19FUJ2C58T)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
BEHENETH-20 (UNII: BJ4GP2IFLN)  
DOCOSANOL (UNII: 9G1OE216XY)  
HYDROGENATED PALM OIL (UNII: 257THB963H)  
PALM KERNEL OIL (UNII: B0S90M0233)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-237-101 in 1 CARTON10/01/2014
120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/2014
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICA INC.782677132manufacture(58411-237) , analysis(58411-237)

Revised: 12/2018
Document Id: 7df47be5-ab9d-5b67-e053-2a91aa0a6956
Set id: 9595cfc1-97ee-4ba1-8bd9-0a9575c73229
Version: 2
Effective Time: 20181226
 
SHISEIDO AMERICAS CORPORATION