SHISEIDO BENEFIANCE WRINKLERESIST24 DAY- octinoxate and octocrylene emulsion 
SHISEIDO AMERICA INC.

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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SHISEIDO BENEFIANCE WRINKLERESIST24 DAY EMULSION

Drug Facts

Active ingredientsPurpose
OCTINOXATE 4.9%Sunscreen
OCTOCRYLENE 5.0%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 smoothly to face before sun exposure and as needed.
  • children under 6 months of age: ask a doctor.

Inactive Ingredients

WATER, GLYCERIN, DIPROPYLENE GLYCOL, SD ALCOHOL 40-B, XYLITOL, BUTYLENE GLYCOL, SILICA, PHENYL TRIMETHICONE, HYDROGENATED POLYDECENE, PEG-60 GLYCERYL ISOSTEARATE, DIMETHICONE, XANTHAN GUM, PEG/PPG-17/4 DIMETHYL ETHER, PHYTOSTERYL MACADAMIATE, TOCOPHERYL ACETATE, SAPINDUS MUKUROSSI PEEL EXTRACT, UNCARIA GAMBIR EXTRACT, SODIUM ACETYLATED HYALURONATE, HYDROXYPROLINE, THYMUS SERPILLUM EXTRACT, CHLORELLA VULGARIS EXTRACT, BUTYL METHOXYDIBENZOYLMETHANE, BEHENYL ALCOHOL, GLYCERYL STEARATE SE, STEARIC ACID, ISOSTEARIC ACID, BEHENIC ACID, BEHENETH-20, TRIETHANOLAMINE, CELLULOSE GUM, SODIUM METAPHOSPHATE, DISODIUM EDTA, ALCOHOL, BHT, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE, IRON OXIDES

Questions?

1-800-906-7503

PRINCIPAL DISPLAY PANEL - 75mL Bottle Carton

SHI SEIDO

BENEFIANCE
WrinkleResist24

Day Emulsion
SPF 15 • PA++
SUNSCREEN

75mL 2.5 FL. OZ.

Principal Display Panel - 75mL Bottle Carton
SHISEIDO  BENEFIANCE WRINKLERESIST24 DAY
octinoxate and octocrylene emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-231
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.81465 g  in 77.85 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3.8925 g  in 77.85 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
XYLITOL (UNII: VCQ006KQ1E)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
XANTHAN GUM (UNII: TTV12P4NEE)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
HYDROXYPROLINE (UNII: RMB44WO89X)  
CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
AVOBENZONE (UNII: G63QQF2NOX)  
DOCOSANOL (UNII: 9G1OE216XY)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
DOCOSANOIC ACID, 1-(((1-OXODECYL)OXY)METHYL)-2-((1-OXOOCTYL)OXY)ETHYL ESTER, (+/-)- (UNII: 8721C76X6A)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALCOHOL (UNII: 3K9958V90M)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52686-231-101 in 1 CARTON02/01/201112/01/2015
177.85 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 finalpart35202/01/201112/01/2015
Labeler - SHISEIDO AMERICA INC. (782677132)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICA INC.782677132manufacture(52686-231) , analysis(52686-231)

Revised: 9/2023
Document Id: aae4fb46-f1f5-4825-969f-b952e874695f
Set id: fdd8acaf-331b-4e89-8298-559e7fbe06c0
Version: 3
Effective Time: 20230928
 
SHISEIDO AMERICA INC.