Label: NISEKO SUNSCREEN SPF 25- avobenzone, octinoxate, and octisalate cream

  • 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 December 10, 2018

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Avobenzone 3.0%
    Octinoxate 7.5%
    Octisalate 5.0%

  • Purpose

    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

    • apply liberally 15 minutes before sun exposure
    • apply to all skin exposed to the sun
    • reapply:
      • at least every 2 hours
      • use water-resistant sunscreen if swimming or sweating
    • 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

    Purified Water, Cyclomethicone, C12-15 Alkyl Lactate, Butyloctyl Salicylate, Glyceryl Stearate SE, Isododecane, Glycerin, Cetearyl Alcohol, Butylene/Ethylene/Propylene Copolymer, Polyacrylamide, Cetyl Alcohol, Dicetyl Phosphate, Ceteth-10 Phosphate, Cholesterol, Tocopheryl Acetate, Edetate Disodium, Methylparaben, Phenoxyethanol, Xanthan Gum, Camellia Sinensis Leaf (Green Tea) Extract, Camellia Sinensis Leaf (White Tea) Extract, C13-C14 Isoparaffin, Laureth-7.

  • Other information

    • protect product from excessive heat and direct sun
  • Questions or comments?

    call 1-973-882-7512

  • SPL UNCLASSIFIED SECTION

    Mfd. by: IGI Laboratories, Inc., Buena, NJ 08310

  • PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

    niseko®

    SUNSCREEN

    Broad Spectrum
    SPF 25

    UVA/UVB Protection

    Formulated with
    Green & White Tea • Vitamin E

    Dermatologist-tested
    Non-comedogenic

    Net Wt. 3 oz (85 g)

    MEDIMETRIKS
    PHARMACEUTICALS, INC.

    Principal Display Panel - 85 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    NISEKO SUNSCREEN SPF 25 
    avobenzone, octinoxate, and octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43538-290
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 g
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 g
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    C12-15 Alkyl lactate (UNII: GC844VRD7E)  
    butyloctyl salicylate (UNII: 2EH13UN8D3)  
    Glyceryl Stearate SE (UNII: FCZ5MH785I)  
    isododecane (UNII: A8289P68Y2)  
    glycerin (UNII: PDC6A3C0OX)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetyl alcohol (UNII: 936JST6JCN)  
    dihexadecyl phosphate (UNII: 2V6E5WN99N)  
    ceteth-10 phosphate (UNII: 4E05O5N49G)  
    cholesterol (UNII: 97C5T2UQ7J)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    edetate disodium (UNII: 7FLD91C86K)  
    methylparaben (UNII: A2I8C7HI9T)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    xanthan gum (UNII: TTV12P4NEE)  
    green tea leaf (UNII: W2ZU1RY8B0)  
    C13-14 isoparaffin (UNII: E4F12ROE70)  
    Laureth-7 (UNII: Z95S6G8201)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43538-290-996 in 1 CARTON11/15/2013
    13 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:43538-290-031 in 1 CARTON11/15/2013
    285 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/15/2013
    Labeler - Medimetriks Pharmaceuticals, Inc. (019903816)
    Establishment
    NameAddressID/FEIBusiness Operations
    Teligent Inc011036910MANUFACTURE(43538-290)