Label: SHISEIDO BENEFIANCE WRINKLERESIST24 DAY- avobenzone, octinoxate, and octocrylene emulsion

  • NDC Code(s): 58411-628-10
  • Packager: SHISEIDO AMERICAS CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated February 25, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    AVOBENZON 2.5 %Sunscreen
    OCTINOXATE 7.4 %Sunscreen
    OCTOCRYLENE 2.0 % Sunscreen
  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  • 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:

    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every two hours
    • Sun Protection Measures.
      Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
      • limit time in the sun, especially from 10 a.m. – 2 p.m.
      • wear long-sleeve shirts, pants, hats, and sunglasses
      • children under 6 months: Ask a doctor
  • Inactive Ingredients

    WATER•GLYCERIN•SD ALCOHOL 40-B•DIPROPYLENE GLYCOL•XYLITOL•BUTYLENE GLYCOL•SILICA•POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER•HYDROGENATED POLYDECENE•PEG-60 GLYCERYL ISOSTEARATE•TRIISOSTEARIN•DIMETHICONE•DIPHENYLSILOXY PHENYL TRIMETHICONE•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•STEARIC ACID•GLYCERYL STEARATE SE•BEHENYL ALCOHOL•ISOSTEARIC ACID•BEHENIC ACID•BEHENETH-20•TRIETHANOLAMINE•CELLULOSE GUM•DISODIUM EDTA•SODIUM METAPHOSPHATE•ALCOHOL•BHT•TOCOPHEROL•PHENOXYETHANOL•FRAGRANCE•IRON OXIDES•

  • Other information

    Protect this product in this container from excessive heat and direct sun.

  • Questions or comments?

    Call toll free 1-800-906-7503

  • PRINCIPAL DISPLAY PANEL - 75 mL Bottle Carton

    SHISEIDO

    BENEFIANCE

    WrinkleResist24

    Day Emulsion

    BROAD SPECTRUM
    SPF 18
    SUNSCREEN

    75mL 2.5 FL. OZ.

    Principal Display Panel - 75 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    SHISEIDO BENEFIANCE WRINKLERESIST24 DAY 
    avobenzone, octinoxate, and octocrylene emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-628
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.94 g  in 75 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5.83 g  in 75 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.55 g  in 75 mL
    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)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-60 GLYCERYL ISOSTEARATE (UNII: WQP0973914)  
    TRIISOSTEARIN (UNII: 71503RH8KG)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K)  
    PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    SAPINDUS MUKOROSSI FRUIT RIND (UNII: 3D1P12PN9U)  
    UNCARIA GAMBIR WHOLE (UNII: K63NT5I1B8)  
    SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
    HYDROXYPROLINE (UNII: RMB44WO89X)  
    CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    BEHENIC ACID (UNII: H390488X0A)  
    BEHENETH-20 (UNII: BJ4GP2IFLN)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    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:58411-628-101 in 1 CARTON01/01/2021
    175 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/01/2021
    Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
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