SHISEIDO BENEFIANCE WRINKLERESIST24 PROTECTIVE HAND REVITALIZER- avobenzone, 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 WRINKLERESIST24 PROTECTIVE HAND REVITALIZER

Drug Facts

Active ingredientsPurpose
AVOBENZONE 2.5%Sunscreen
OCTINOXATE 4.9%Sunscreen
OCTOCRYLENE 5.0%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•CAPRYLIC/CAPRIC TRIGLYCERIDE•BEHENYL ALCOHOL•BUTYLENE GLYCOL•ISOHEXADECANE•SD ALCOHOL 40-B•SORBITOL•SILICA•MYRISTYL MYRISTATE•DIMETHICONE•POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER•STEARYL ALCOHOL•TRIISOSTEARIN•PHYTOSTERYL MACADAMIATE•TOCOPHERYL ACETATE•2-O-ETHYL ASCORBIC ACID•POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE•ARGININE HCl•SAXIFRAGA SARMENTOSA EXTRACT•SAPINDUS MUKUROSSI PEEL EXTRACT•PANAX GINSENG ROOT EXTRACT•ANGELICA ACUTILOBA ROOT EXTRACT•SODIUM ACETYLATED HYALURONATE•HYDROXYPROLINE•UNCARIA GAMBIR EXTRACT•CHLORELLA VULGARIS EXTRACT•THYMUS SERPILLUM EXTRACT•BEHENETH-20•ALCOHOL•SUCCINOGLYCAN•TRISODIUM EDTA•SODIUM CITRATE•SODIUM METAPHOSPHATE•CITRIC ACID•BHT•SODIUM METABISULFITE•TOCOPHEROL•PHENOXYETHANOL•FRAGRANCE•IRON OXIDES•

Other information

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 75 mL Tube Carton

SHI SEIDO

BENEFIANCE
WrinkleResist24

Protective
Hand Revitalizer

BROAD SPECTRUM
SPF 15

SUNSCREEN

75mL NET WT. 2.6 OZ.

PRINCIPAL DISPLAY PANEL - 75 mL Tube Carton
SHISEIDO BENEFIANCE WRINKLERESIST24 PROTECTIVE HAND REVITALIZER 
avobenzone, octinoxate, octocrylene, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-255
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1922 mg  in 75 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3767 mg  in 75 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3844 mg  in 75 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE1153 mg  in 75 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
DOCOSANOL (UNII: 9G1OE216XY)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
SORBITOL (UNII: 506T60A25R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
TRIISOSTEARIN (UNII: 71503RH8KG)  
BEHENETH-20 (UNII: BJ4GP2IFLN)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALCOHOL (UNII: 3K9958V90M)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER)  
ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y)  
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)  
SAPINDUS MUKOROSSI FRUIT RIND (UNII: 3D1P12PN9U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
HYDROXYPROLINE (UNII: RMB44WO89X)  
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
THYMUS SERPYLLUM (UNII: 86H4S6K51N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-255-601 in 1 CARTON09/01/2015
175 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/01/2015
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICA INC.782677132manufacture(58411-255) , analysis(58411-255)

Revised: 12/2018
Document Id: 7d6ae847-fcbd-28a3-e053-2991aa0a9cc5
Set id: 890ed835-2e64-4223-81aa-167719c39507
Version: 3
Effective Time: 20181219
 
SHISEIDO AMERICAS CORPORATION