Label: AGELOC TRANSFORMATION- avobenzone, homosalate, octisalate, and octocrylene kit

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated December 20, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Avobenzone (3%),
    Homosalate (5%),
    Octisalate (4%), Octocrylene (2%).

  • 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.

    • 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

    • Illuminate your skin each day. To complete your morning regimen, squeeze a pea-sized amount onto fingertips and apply in an upward, outward motion to face and neck. Avoid 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.–2 p.m.
      • Wear longsleeved shirts, pants, hats, and sunglasses.
      • 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), Glycerin, Cetyl Dimethicone, Cyclopentasiloxane, Acrylamide/Sodium Acryloyldimethyltaurate Copolymer, Caprylyl Glycol, Glyceryl Stearate, PEG-100 Stearate, Dimethicone, Cyclohexasiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Cetyl Alcohol, Methyl Gluceth-10, Steareth-2, Steareth-21, Isohexadecane, Nylon-12, Hydrolyzed Jojoba Esters, Jojoba Esters, Bambusa Vulgaris Leaf/Stem Extract, Glucosamine HCl, Pisum Sativum (Pea) Extract, Hexapeptide-2, Narcissus Tazetta Bulb Extract, Schizandra Chinensis Fruit Extract, Butyrospermum Parkii (Shea Butter), Polysorbate 80, Titanium Dioxide, Butylene Glycol, Citric Acid, Disodium EDTA, Fragrance (Parfum), Chlorphenesin, Phenoxyethanol.

  • Questions

    1-888-742-7626

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    ageLOC® TRANSFORMATION

    GENTLE CLEANSE & TONE
    FUTURE SERUM
    RADIANT DAY
    TRANSFORMING NIGHT

    NU SKIN®

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    AGELOC TRANSFORMATION 
    avobenzone, homosalate, octisalate, and octocrylene kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62839-3888
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62839-3888-11 in 1 CARTON05/01/2013
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE, WITH APPLICATOR 25 mL
    Part 21 BOTTLE, PUMP 60 mL
    Part 31 BOTTLE, PUMP 30 mL
    Part 41 JAR 30 mL
    Part 1 of 4
    NU SKIN AGELOC RADIANT DAY BROAD SPECTRUM SPF 22 
    avobenzone, homosalate, octisalate, and octocrylene lotion
    Product Information
    Item Code (Source)NDC:62839-3904
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate50 mg  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate40 mg  in 1 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Methyl Gluceth-10 (UNII: N0MWT4C7WH)  
    Steareth-2 (UNII: V56DFE46J5)  
    Steareth-21 (UNII: 53J3F32P58)  
    Isohexadecane (UNII: 918X1OUF1E)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Nylon-12 (UNII: 446U8J075B)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    Cyclomethicone 6 (UNII: XHK3U310BA)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Glucosamine Hydrochloride (UNII: 750W5330FY)  
    Shea Butter (UNII: K49155WL9Y)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Pea (UNII: W4X7H8GYFM)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Bambusa Vulgaris Top (UNII: FIW80T6P6V)  
    Narcissus Tazetta Bulb (UNII: K17762966S)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Schisandra Chinensis Fruit (UNII: ABS794681C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62839-3904-125 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35205/01/2013
    Part 2 of 4
    AGELOC GENTLE CLEANSE AND TONE 
    cleansing (cold creams, cleansing lotions, liquids, and pads) liquid
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWater (UNII: 059QF0KO0R)  
    INGRGlycerin (UNII: PDC6A3C0OX)  
    INGRCocamidopropyl Hydroxysultaine (UNII: 62V75NI93W)  
    INGRBetaine (UNII: 3SCV180C9W)  
    INGRSodium Methyl Cocoyl Taurate (UNII: JVL98CG53G)  
    INGRDisodium Laureth Sulfosuccinate (UNII: D6DH1DTN7E)  
    INGR1,2-Hexanediol (UNII: TR046Y3K1G)  
    INGRCaprylyl Glycol (UNII: 00YIU5438U)  
    INGRPolysorbate 20 (UNII: 7T1F30V5YH)  
    INGRSodium Benzoate (UNII: OJ245FE5EU)  
    INGRCitric Acid Monohydrate (UNII: 2968PHW8QP)  
    INGREdetate Disodium (UNII: 7FLD91C86K)  
    INGRNarcissus Tazetta Bulb (UNII: K17762966S)  
    INGRSchisandra Chinensis Fruit (UNII: ABS794681C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    160 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic05/01/2013
    Part 3 of 4
    AGELOC FUTURE SERUM 
    other skin care preparations gel
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWater (UNII: 059QF0KO0R)  
    INGRButylene Glycol (UNII: 3XUS85K0RA)  
    INGRCyclomethicone 5 (UNII: 0THT5PCI0R)  
    INGRGlycerin (UNII: PDC6A3C0OX)  
    INGRPentylene Glycol (UNII: 50C1307PZG)  
    INGRIsoceteth-20 (UNII: O020065R7Z)  
    INGRCreatinine (UNII: AYI8EX34EU)  
    INGRDimethicone (UNII: 92RU3N3Y1O)  
    INGRGlucosamine Hydrochloride (UNII: 750W5330FY)  
    INGRPolysorbate 80 (UNII: 6OZP39ZG8H)  
    INGRLemon Peel (UNII: 72O054U628)  
    INGRBetasizofiran (UNII: 2X51AD1X3T)  
    INGRCetyl Alcohol (UNII: 936JST6JCN)  
    INGRChlorphenesin (UNII: I670DAL4SZ)  
    INGRGlyceryl Monostearate (UNII: 230OU9XXE4)  
    INGRAmmonium Acryloyldimethyltaurate/VP Copolymer (UNII: W59H9296ZG)  
    INGRPea (UNII: W4X7H8GYFM)  
    INGRBambusa Vulgaris Top (UNII: FIW80T6P6V)  
    INGRPEG-75 Stearate (UNII: OT38R0N74H)  
    INGRXanthan Gum (UNII: TTV12P4NEE)  
    INGRPullulan (UNII: 8ZQ0AYU1TT)  
    INGRIsohexadecane (UNII: 918X1OUF1E)  
    INGRCitric Acid Monohydrate (UNII: 2968PHW8QP)  
    INGRPotassium Sorbate (UNII: 1VPU26JZZ4)  
    INGRCeteth-20 (UNII: I835H2IHHX)  
    INGRDecyl Glucoside (UNII: Z17H97EA6Y)  
    INGRSteareth-20 (UNII: L0Q8IK9E08)  
    INGREdetate Disodium (UNII: 7FLD91C86K)  
    INGRPhenoxyethanol (UNII: HIE492ZZ3T)  
    INGRHyaluronate Sodium (UNII: YSE9PPT4TH)  
    INGRNarcissus Tazetta Bulb (UNII: K17762966S)  
    INGRSchisandra Chinensis Fruit (UNII: ABS794681C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic05/01/2013
    Part 4 of 4
    AGELOC TRANSFORMING NIGHT 
    night cream
    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)  
    INGRShea Butter (UNII: K49155WL9Y)  
    INGRMedium-Chain Triglycerides (UNII: C9H2L21V7U)  
    INGRAmmonium Acryloyldimethyltaurate/VP Copolymer (UNII: W59H9296ZG)  
    INGRSorbitol (UNII: 506T60A25R)  
    INGRChlorphenesin (UNII: I670DAL4SZ)  
    INGRGlucosamine Hydrochloride (UNII: 750W5330FY)  
    INGRSqualane (UNII: GW89575KF9)  
    INGRXanthan Gum (UNII: TTV12P4NEE)  
    INGRPea (UNII: W4X7H8GYFM)  
    INGREdetate Sodium (UNII: MP1J8420LU)  
    INGRBambusa Vulgaris Top (UNII: FIW80T6P6V)  
    INGRNarcissus Tazetta Bulb (UNII: K17762966S)  
    INGRCitric Acid Monohydrate (UNII: 2968PHW8QP)  
    INGRSchisandra Chinensis Fruit (UNII: ABS794681C)  
    INGRHyaluronate Sodium (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic05/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35205/01/2013
    Labeler - NSE Products, Inc. (803486393)