Label: NU SKIN AGELOC ME- homosalate, octinoxate, avobenzone, and octocrylene kit

  • 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 April 19, 2016

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

  • 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 longsleeved 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 - Kit Carton

    ageLOC me™

    NU SKIN®

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    NU SKIN AGELOC ME 
    homosalate, octinoxate, avobenzone, and octocrylene kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62839-1640
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62839-1640-11 in 1 CARTON05/01/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 CARTRIDGE 28 mL
    Part 21 CARTRIDGE 28 mL
    Part 31 CARTRIDGE 12 mL
    Part 41 CARTRIDGE 12 mL
    Part 51 CARTRIDGE 12 mL
    Part 1 of 5
    NU SKIN AGELOC ME DAY S1 BROAD SPECTRUM SPF 25 
    homosalate, octinoxate, avobenzone, and octocrylene lotion
    Product Information
    Item 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)  
    Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 mpa.s at 1.5%) (UNII: 86FQE96TZ4)  
    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:62839-1617-128 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
    Part 2 of 5
    NU SKIN AGELOC ME NIGHT Z7 
    night lotion
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWater (UNII: 059QF0KO0R)  
    INGRGlycerin (UNII: PDC6A3C0OX)  
    INGRPentylene Glycol (UNII: 50C1307PZG)  
    INGRCaprylyl Trisiloxane (UNII: Q95M2P1KJL)  
    INGRCyclomethicone 5 (UNII: 0THT5PCI0R)  
    INGRMedium-Chain Triglycerides (UNII: C9H2L21V7U)  
    INGRShea Butter (UNII: K49155WL9Y)  
    INGRHydrogenated Soybean Lecithin (UNII: H1109Z9J4N)  
    INGRAmmonium Acryloyldimethyltaurate/VP Copolymer (UNII: W59H9296ZG)  
    INGRSorbitol (UNII: 506T60A25R)  
    INGRRice Germ (UNII: 7N2B70SFEZ)  
    INGRChlorphenesin (UNII: I670DAL4SZ)  
    INGRSqualane (UNII: GW89575KF9)  
    INGRXanthan Gum (UNII: TTV12P4NEE)  
    INGREdetate Disodium (UNII: 7FLD91C86K)  
    INGRCeramide NP (UNII: 4370DF050B)  
    INGRAminomethylpropanol (UNII: LU49E6626Q)  
    INGRHyaluronate Sodium (UNII: YSE9PPT4TH)  
    INGRSchisandra Chinensis Fruit (UNII: ABS794681C)  
    INGROat (UNII: Z6J799EAJK)  
    INGRPotassium Sorbate (UNII: 1VPU26JZZ4)  
    INGRNarcissus Tazetta Bulb (UNII: K17762966S)  
    INGRCitric Acid Monohydrate (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    128 mL in 1 CARTRIDGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic05/01/2016
    Part 3 of 5
    NU SKIN AGELOC ME SERUM Q5 
    other skin care preparations lotion
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWater (UNII: 059QF0KO0R)  
    INGRCyclomethicone 5 (UNII: 0THT5PCI0R)  
    INGRSilicon Dioxide (UNII: ETJ7Z6XBU4)  
    INGRCyclomethicone 6 (UNII: XHK3U310BA)  
    INGRPentylene Glycol (UNII: 50C1307PZG)  
    INGRGlycerin (UNII: PDC6A3C0OX)  
    INGRSoybean Oil (UNII: 241ATL177A)  
    INGRBis-PEG-18 Methyl Ether Dimethyl Silane (UNII: OEB4R3WW9C)  
    INGRPEG-60 Hydrogenated Castor Oil (UNII: 02NG325BQG)  
    INGRMethyl Gluceth-20 (UNII: J3QD0LD11P)  
    INGRButylene Glycol (UNII: 3XUS85K0RA)  
    INGRRice Germ (UNII: 7N2B70SFEZ)  
    INGRCarbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)  
    INGRAminomethylpropanol (UNII: LU49E6626Q)  
    INGRChlorphenesin (UNII: I670DAL4SZ)  
    INGRXanthan Gum (UNII: TTV12P4NEE)  
    INGRCarnosine (UNII: 8HO6PVN24W)  
    INGRDicaprylyl Ether (UNII: 77JZM5516Z)  
    INGRCarboxypolymethylene (UNII: 0A5MM307FC)  
    INGREdetate Disodium (UNII: 7FLD91C86K)  
    INGRAdenosine (UNII: K72T3FS567)  
    INGRPolysorbate 20 (UNII: 7T1F30V5YH)  
    INGRMagnolia Grandiflora Bark (UNII: J4XF5T6418)  
    INGRLauryl Alcohol (UNII: 178A96NLP2)  
    INGRHyaluronate Sodium (UNII: YSE9PPT4TH)  
    INGRSchisandra Chinensis Fruit (UNII: ABS794681C)  
    INGRNarcissus Tazetta Bulb (UNII: K17762966S)  
    INGRPalmitoyl Tetrapeptide-7 (UNII: Q41S464P1R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    112 mL in 1 CARTRIDGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic05/01/2016
    Part 4 of 5
    NU SKIN AGELOC ME SERUM X4 
    other skin care preparations lotion
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWater (UNII: 059QF0KO0R)  
    INGRCyclomethicone 5 (UNII: 0THT5PCI0R)  
    INGRPentylene Glycol (UNII: 50C1307PZG)  
    INGRCyclomethicone 6 (UNII: XHK3U310BA)  
    INGRSoybean Oil (UNII: 241ATL177A)  
    INGRBis-PEG-18 Methyl Ether Dimethyl Silane (UNII: OEB4R3WW9C)  
    INGRMethyl Gluceth-20 (UNII: J3QD0LD11P)  
    INGRPEG-60 Hydrogenated Castor Oil (UNII: 02NG325BQG)  
    INGRSilicon Dioxide (UNII: ETJ7Z6XBU4)  
    INGRLemon Peel (UNII: 72O054U628)  
    INGRButylene Glycol (UNII: 3XUS85K0RA)  
    INGRLevomenol (UNII: 24WE03BX2T)  
    INGRGlycerin (UNII: PDC6A3C0OX)  
    INGRRice Germ (UNII: 7N2B70SFEZ)  
    INGRCarbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)  
    INGRXanthan Gum (UNII: TTV12P4NEE)  
    INGRMedium-Chain Triglycerides (UNII: C9H2L21V7U)  
    INGRChlorphenesin (UNII: I670DAL4SZ)  
    INGRAminomethylpropanol (UNII: LU49E6626Q)  
    INGRDicaprylyl Ether (UNII: 77JZM5516Z)  
    INGRGreen Tea Leaf (UNII: W2ZU1RY8B0)  
    INGREdetate Disodium (UNII: 7FLD91C86K)  
    INGRHyaluronate Sodium (UNII: YSE9PPT4TH)  
    INGRMagnolia Grandiflora Bark (UNII: J4XF5T6418)  
    INGRLauryl Alcohol (UNII: 178A96NLP2)  
    INGRSchisandra Chinensis Fruit (UNII: ABS794681C)  
    INGRNarcissus Tazetta Bulb (UNII: K17762966S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    112 mL in 1 CARTRIDGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic05/01/2016
    Part 5 of 5
    NU SKIN AGELOC ME SERUM R1 
    other skin care preparations lotion
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWater (UNII: 059QF0KO0R)  
    INGRPentylene Glycol (UNII: 50C1307PZG)  
    INGRDicaprylyl Carbonate (UNII: 609A3V1SUA)  
    INGREthylhexyl Isononanoate (UNII: I6KB4GE3K4)  
    INGRBis-PEG-18 Methyl Ether Dimethyl Silane (UNII: OEB4R3WW9C)  
    INGRSoybean Oil (UNII: 241ATL177A)  
    INGRMethyl Gluceth-20 (UNII: J3QD0LD11P)  
    INGRCetostearyl Alcohol (UNII: 2DMT128M1S)  
    INGRCyclomethicone 5 (UNII: 0THT5PCI0R)  
    INGRGlyceryl Monostearate (UNII: 230OU9XXE4)  
    INGRPEG-100 Stearate (UNII: YD01N1999R)  
    INGRPPG-3 Benzyl Ether Myristate (UNII: 8075L58MKO)  
    INGRGlucosamine Hydrochloride (UNII: 750W5330FY)  
    INGRCyclomethicone 6 (UNII: XHK3U310BA)  
    INGRPea (UNII: W4X7H8GYFM)  
    INGRPhenoxyethanol (UNII: HIE492ZZ3T)  
    INGRSilicon Dioxide (UNII: ETJ7Z6XBU4)  
    INGR.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    INGRGlycerin (UNII: PDC6A3C0OX)  
    INGRBambusa Vulgaris Top (UNII: FIW80T6P6V)  
    INGRRice Germ (UNII: 7N2B70SFEZ)  
    INGRAcacia (UNII: 5C5403N26O)  
    INGRChlorphenesin (UNII: I670DAL4SZ)  
    INGRXanthan Gum (UNII: TTV12P4NEE)  
    INGR4-Tert-Butylcyclohexanol (UNII: K0H1405S9C)  
    INGRPolysorbate 20 (UNII: 7T1F30V5YH)  
    INGREdetate Disodium (UNII: 7FLD91C86K)  
    INGRDicaprylyl Ether (UNII: 77JZM5516Z)  
    INGRAdenosine (UNII: K72T3FS567)  
    INGRHyaluronate Sodium (UNII: YSE9PPT4TH)  
    INGRSchisandra Chinensis Fruit (UNII: ABS794681C)  
    INGRMagnolia Grandiflora Bark (UNII: J4XF5T6418)  
    INGRLauryl Alcohol (UNII: 178A96NLP2)  
    INGRNarcissus Tazetta Bulb (UNII: K17762966S)  
    INGRAminomethylpropanol (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    112 mL in 1 CARTRIDGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic05/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35205/01/2016
    Labeler - NSE Products, Inc. (803486393)