Label: NU SKIN AGELOC ME DAY S1 BROAD SPECTRUM SPF 25- homosalate, octinoxate, avobenzone, and octocrylene 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 December 24, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Homosalate (4.0%),
    Octinoxate (3.5%),
    Avobenzone (3.0%),
    Octocrylene (2.79%)

  • 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

    • 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

    • After applying serum and allowing it to dry, apply moisturizer in an upward, outward motion to the face and neck. If layering additional products, allow each to dry completely before applying the next.
    • 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), Butylene Glycol, Caprylyl Methicone, Nylon-6/12, Octyldodecyl Neopentanoate, Glycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Oryza Sativa (Rice) Extract, Methoxy PEG/PPG-25/4 Dimethicone, Hydrogenated Phosphatidylcholine, Caprylic/Capric Triglyceride, 4-t-Butylcyclohexanol, Hydroxyacetophenone, Polyisobutene, Schizandra Chinensis Fruit Extract, Camellia Sinensis Leaf Extract, Allantoin, Pentylene Glycol, 7-Dehydrocholesterol, Paeonia Lactiflora Extract, Epilobium Angustifolium Flower/Leaf/Stem Extract, Tocopherol, Narcissus Tazetta Bulb Extract, PEG-7 Trimethylolpropane Coconut Ether, Sorbitan Isostearate, Hydroxyphenyl Propamidobenzoic Acid, Bis-PEG/PPG-20/5 PEG/PPG-20/5 Dimethicone, Zea Mays (Corn) Oil, Xanthan Gum, Aminomethyl Propanol, Disodium EDTA, Chlorphenesin

  • Other Information

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

    1-888-742-7626

  • PRINCIPAL DISPLAY PANEL - 28 ml Cartridge Carton

    NU SKIN®

    ageLOC me DAY S1 BROAD SPECTRUM SPF 25

    28 ml e (0.95 fl . oz.)

    Principal Display Panel - 28 ml Cartridge Carton
  • INGREDIENTS AND APPEARANCE
    NU SKIN AGELOC ME DAY S1 BROAD SPECTRUM SPF 25 
    homosalate, octinoxate, avobenzone, and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62839-1617
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate40 mg  in 1 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate35 mg  in 1 mL
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene27.9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Octyldodecyl Neopentanoate (UNII: X8725R883T)  
    Caprylyl Trisiloxane (UNII: Q95M2P1KJL)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    Glycerin (UNII: PDC6A3C0OX)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Rice Germ (UNII: 7N2B70SFEZ)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    4-tert-Butylcyclohexanol (UNII: K0H1405S9C)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    Allantoin (UNII: 344S277G0Z)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Epilobium Angustifolium Flowering Top (UNII: 08H094218D)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Sorbitan Isostearate (UNII: 01S2G2C1E4)  
    Hydroxyphenyl Propamidobenzoic Acid (UNII: 25KRT26H77)  
    Schisandra Chinensis Fruit (UNII: ABS794681C)  
    Corn Oil (UNII: 8470G57WFM)  
    Narcissus Tazetta Bulb (UNII: K17762966S)  
    7-Dehydrocholesterol (UNII: BK1IU07GKF)  
    Aminomethylpropanol (UNII: LU49E6626Q)  
    Tocopherol (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62839-1617-11 in 1 CARTON05/01/2016
    128 mL in 1 CARTRIDGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35205/01/2016
    Labeler - NSE Products, Inc. (803486393)