SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAY- avobenzone, homosalate, octinoxate, octocrylene, and oxybenzone 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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SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAY CREAM

Drug Facts

Active ingredientsPurpose
AVOBENZONE 2.0%Sunscreen
HOMOSALATE 5.0%Sunscreen
OCTINOXATE 7.4%Sunscreen
OCTOCRYLENE 3.0%Sunscreen
OXYBENZONE 1.5%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:

Inactive Ingredients

WATER•GLYCERIN•DIPROPYLENE GLYCOL•BUTYLENE GLYCOL•BEHENYL ALCOHOL•SD ALCOHOL 40-B•SILICA•DIMETHICONE•ISODODECANE•ISOHEXADECANE•SORBITOL•BEHENETH-20•MYRISTYL MYRISTATE•PHYTOSTERYL MACADAMIATE•ERYTHRITOL•XANTHAN GUM•TOCOPHERYL ACETATE•PEG/PPG-14/7 DIMETHYL ETHER•PEG/PPG-17/4 DIMETHYL ETHER•CAFFEINE•SAPINDUS MUKOROSSI PEEL EXTRACT•ANGELICA KEISKEI LEAF/STEM EXTRACT•CAMELLIA SINENSIS LEAF EXTRACT•CITRUS JUNOS SEED EXTRACT•ZIZIPHUS JUJUBA FRUIT EXTRACT•EUCHEUMA SERRA/GRATELOUPIA SPARSA/SACCHARINA ANGUSTATA/ULVA LINZA/UNDARIA PINNATIFIDA EXTRACT•CURCUMA LONGA (TURMERIC) RHIZOME EXTRACT•POLYQUATERNIUM-51•SACCHARINA ANGUSTATA/UNDARIA PINNATIFIDA EXTRACT•CHLORELLA VULGARIS EXTRACT•PPG-17•STEARYL ALCOHOL•BEHENETH-30•ALCOHOL•CARBOMER•CELLULOSE GUM•TRISODIUM EDTA•HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER•SODIUM CITRATE•BHT•SODIUM METAPHOSPHATE•POTASSIUM HYDROXIDE•CITRIC ACID•TOCOPHEROL•PPG-3 DIPIVALATE•SODIUM METABISULFITE•PHENOXYETHANOL•FRAGRANCE•IRON OXIDES•

Other information

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 50 mL Jar Carton

SHISEIDO
GINZA TOKYO

Benefiance

Wrinkle Smoothing Day Cream

BROAD SPECTRUM
SPF 23
SUNSCREEN

ReNeura Technology+

Wrinkles

50mL NET WT. 1.8 OZ.

PRINCIPAL DISPLAY PANEL - 50 mL Jar Carton
SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAY 
avobenzone, homosalate, octinoxate, octocrylene, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-439
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1032 mg  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE2580 mg  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3818 mg  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1548 mg  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE774 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DOCOSANOL (UNII: 9G1OE216XY)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISODODECANE (UNII: A8289P68Y2)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
SORBITOL (UNII: 506T60A25R)  
BEHENETH-20 (UNII: BJ4GP2IFLN)  
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
ERYTHRITOL (UNII: RA96B954X6)  
XANTHAN GUM (UNII: TTV12P4NEE)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K)  
CAFFEINE (UNII: 3G6A5W338E)  
SAPINDUS MUKOROSSI FRUIT RIND (UNII: 3D1P12PN9U)  
ANGELICA KEISKEI TOP (UNII: AP628M4TQO)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CITRUS JUNOS SEED (UNII: UY43O1Q45N)  
JUJUBE FRUIT (UNII: G55HNL2C70)  
TURMERIC (UNII: 856YO1Z64F)  
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
PPG-17 (UNII: OV0Q322E0U)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
BEHENETH-30 (UNII: 21Z34J9KN8)  
ALCOHOL (UNII: 3K9958V90M)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-439-501 in 1 CARTON06/01/2018
150 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/01/2018
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICA INC.782677132MANUFACTURE(58411-439) , ANALYSIS(58411-439)

Revised: 5/2018
Document Id: 48b92c4e-c985-4051-affa-11a9d2de9182
Set id: 4bd99626-690b-49e8-8c42-a2e2dbca09bf
Version: 1
Effective Time: 20180509
 
SHISEIDO AMERICAS CORPORATION