Label: NU SKIN SUNRIGHT LIP BALM BROAD SPECTRUM SPF 15- octinoxate and octocrylene stick

  • 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 June 26, 2014

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Octinoxate 7.5%, Octocrylene 2.79%

  • Purpose

    Sunscreen

  • Use

    • Helps prevent sunburn. Higher SPF gives more sunburn protection.
    • 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 the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • Apply liberally 15 minutes before sun exposure.
    • Use a water resistant sunscreen if swimming or sweating.
    • Reapply at least every two hours.
    • Children under 6 months: Ask a doctor.
    • Sunprotection 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-sleeved shirts, pants, hats, and sunglasses.
  • Inactive Ingredients

    Beeswax, Butyl Methoxydibenzoylmethane, Caprylic/Capric Triglyceride, Chlorella Vulgaris Extract, Ethylhexylglycerin, Ethyl Vanillin, Euphorbia Cerifera (Candelilla) Wax, Flavor (Aroma), Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Seed Oil, Octyldodecyl Neopentanoate, Ozokerite, Phenoxyethanol, Polyethylene, Ricinus Communis (Castor) Seed Oil, Silica, Tocopherol, Tocopheryl Acetate, Water (Aqua), Zea Mays (Corn) Starch.

  • Other Information

    • Protect this product from excessive heat and direct sun.
  • Questions?

    1-888-742-7626

  • PRINCIPAL DISPLAY PANEL - 15 ml Pouch Label

    NU SKIN®

    SUNRIGHT®
    Lip Balm
    BROAD SPECTRUM SPF 15

    15 ml e (0.5 fl. oz.)

    Principal Display Panel - 15 ml Pouch Label
  • INGREDIENTS AND APPEARANCE
    NU SKIN SUNRIGHT LIP BALM BROAD SPECTRUM SPF 15 
    octinoxate and octocrylene stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62839-0369
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene27.9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Yellow Wax (UNII: 2ZA36H0S2V)  
    Avobenzone (UNII: G63QQF2NOX)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Chlorella Vulgaris (UNII: RYQ4R60M02)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Ethyl Vanillin (UNII: YC9ST449YJ)  
    Candelilla Wax (UNII: WL0328HX19)  
    Soybean Oil (UNII: 241ATL177A)  
    Sunflower Oil (UNII: 3W1JG795YI)  
    Octyldodecyl Neopentanoate (UNII: X8725R883T)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    High Density Polyethylene (UNII: UG00KM4WR7)  
    Castor Oil (UNII: D5340Y2I9G)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Tocopherol (UNII: R0ZB2556P8)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Water (UNII: 059QF0KO0R)  
    Starch, Corn (UNII: O8232NY3SJ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62839-0369-11 in 1 POUCH
    115 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2014
    Labeler - NSE Products, Inc. (803486393)