Label: NU SKIN 180 DEGREE UV DEFENSE HYDRATOR SPF 18- octinoxate and zinc oxide lotion

  • 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 January 10, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Octinoxate (7.5%), Zinc Oxide (5.4%)

  • Purpose

    Sunscreen

  • Uses

    • 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.

    • Stop use and ask a doctor if rash occurs.

    • When using this product, keep out of eyes. Rinse with water to remove.

    • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • Use in the morning as the fourth step in the Nu Skin 180°® System. Apply lightly in an upward, outward motion to face
      Apply lightly in an upward, outward motion to face and neck, avoiding the eye area.
    • 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. –2p.m.
      • Wear long-sleeved shirts, pants, hats, and sunglasses.
      • Apply liberally 15 minutes before sun exposure
      • Use a water resistant sunscreen if swimming or sweating
      • Reapply at least every 2 hours
    • Children under 6 months: Ask a doctor.
  • Inactive Ingredients

    Water (Aqua), Ethylhexyl Isononanoate, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Methylpropanediol, Pentylene Glycol, Octyldodecyl Neopentanoate, Ceteth-20, Cyclohexasiloxane, Dimethicone, Trilaureth-4 Phosphate, Caprylic/Capric Triglyceride, Glyceryl Stearate, PEG-100 Stearate, Di-C12-15 Alkyl Fumarate, Persea Gratissima (Avocado) Oil, Tocopheryl Acetate, Cetyl Alcohol, Butyrospermum Parkii (Shea) Butter, Lecithin, Ammonium Acryloyldimethyltaurate/VP Copolymer, Stearyl Glycyrrhetinate, Panthenol, Plankton Extract, Steareth-20, Polyhydroxystearic Acid, Butylene Glycol, PEG-75 Stearate, Isostearic Acid, p-Anisic Acid, Xanthan Gum, Disodium EDTA, Citric Acid, Fragrance (Parfum), Phenoxyethanol, Chlorphenesin.

  • Other Information

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

    1-888-742-7626

  • PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

    Nu Skin
    180°®

    UV Defense Hydrator
    Broad Spectrum
    SPF 18

    30 ml e (1 fl. oz.)

    Principal Display Panel - 30 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    NU SKIN 180 DEGREE UV DEFENSE HYDRATOR SPF 18 
    octinoxate and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62839-1254
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide54 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Ethylhexyl Isononanoate (UNII: I6KB4GE3K4)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Methylpropanediol (UNII: N8F53B3R4R)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    Octyldodecyl Neopentanoate (UNII: X8725R883T)  
    Ceteth-20 (UNII: I835H2IHHX)  
    Cyclomethicone 6 (UNII: XHK3U310BA)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Trilaureth-4 Phosphate (UNII: M96W2OLL2V)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Di-C12-15 Alkyl Fumarate (UNII: A1CB3Z898P)  
    Avocado Oil (UNII: 6VNO72PFC1)  
    Shea Butter (UNII: K49155WL9Y)  
    Ammonium Acryloyldimethyltaurate/VP Copolymer (UNII: W59H9296ZG)  
    Stearyl Glycyrrhetinate (UNII: 3YYE6VJS0P)  
    Panthenol (UNII: WV9CM0O67Z)  
    Steareth-20 (UNII: L0Q8IK9E08)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    PEG-75 Stearate (UNII: OT38R0N74H)  
    Isostearic Acid (UNII: X33R8U0062)  
    p-Anisic Acid (UNII: 4SB6Y7DMM3)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62839-1254-11 in 1 CARTON08/01/2013
    130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35208/01/2013
    Labeler - NSE Products, Inc. (803486393)