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

  • Label RSS
  • NDC Code(s): 62839-3888-1, 62839-3904-1
  • Packager: NSE Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 05/13

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredients

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

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  • Purpose

    Sunscreen

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  • 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.
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  • 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.
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  • 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.
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  • 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.

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  • Questions

    1-888-742-7626

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  • PRINCIPAL DISPLAY PANEL - Kit Carton

    ageLOC® TRANSFORMATION

    GENTLE CLEANSE & TONE
    FUTURE SERUM
    RADIANT DAY
    TRANSFORMING NIGHT

    NU SKIN®

    PRINCIPAL DISPLAY PANEL - Kit Carton
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  • INGREDIENTS AND APPEARANCE
    AGELOC TRANSFORMATION 
    avobenzone, homosalate, octisalate, and octocrylene kit
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:62839-3888
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62839-3888-1 1 in 1 CARTON
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 TUBE, WITH APPLICATOR 25 mL
    Part 2 1 BOTTLE, PUMP 60 mL
    Part 3 1 BOTTLE, PUMP 30 mL
    Part 4 1 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 Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Avobenzone (Avobenzone) Avobenzone 30 mg  in 1 mL
    Homosalate (Homosalate) Homosalate 50 mg  in 1 mL
    Octisalate (Octisalate) Octisalate 40 mg  in 1 mL
    Octocrylene (Octocrylene) Octocrylene 20 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Glycerin  
    Cyclomethicone 5  
    Caprylyl Glycol  
    Glyceryl Monostearate  
    PEG-100 Stearate  
    Cetyl Alcohol  
    Methyl Gluceth-10  
    Steareth-2  
    Steareth-21  
    Isohexadecane  
    Dimethicone  
    Nylon-12  
    Phenoxyethanol  
    Chlorphenesin  
    Cyclomethicone 6  
    Polysorbate 80  
    Glucosamine Hydrochloride  
    Shea Butter  
    Titanium Dioxide  
    Pea  
    Butylene Glycol  
    Edetate Disodium  
    Bambusa Vulgaris Top  
    Narcissus Tazetta Bulb  
    Citric Acid Monohydrate  
    Schisandra Chinensis Fruit  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62839-3904-1 25 mL in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part352 05/01/2013
    Part 2 of 4
    AGELOC GENTLE CLEANSE AND TONE 
    cleansing (cold creams, cleansing lotions, liquids, and pads) liquid
    Product Information
    Route of Administration TOPICAL DEA Schedule     
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    INGR Water  
    INGR Glycerin  
    INGR Cocamidopropyl Hydroxysultaine  
    INGR Betaine  
    INGR Sodium Methyl Cocoyl Taurate  
    INGR Disodium Laureth Sulfosuccinate  
    INGR 1,2-Hexanediol  
    INGR Caprylyl Glycol  
    INGR Polysorbate 20  
    INGR Sodium Benzoate  
    INGR Citric Acid Monohydrate  
    INGR Edetate Disodium  
    INGR Narcissus Tazetta Bulb  
    INGR Schisandra Chinensis Fruit  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 60 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Cosmetic 05/01/2013
    Part 3 of 4
    AGELOC FUTURE SERUM 
    other skin care preparations gel
    Product Information
    Route of Administration TOPICAL DEA Schedule     
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    INGR Water  
    INGR Butylene Glycol  
    INGR Cyclomethicone 5  
    INGR Glycerin  
    INGR Pentylene Glycol  
    INGR Isoceteth-20  
    INGR Creatinine  
    INGR Dimethicone  
    INGR Glucosamine Hydrochloride  
    INGR Polysorbate 80  
    INGR Lemon Peel  
    INGR Betasizofiran  
    INGR Cetyl Alcohol  
    INGR Chlorphenesin  
    INGR Glyceryl Monostearate  
    INGR Ammonium Acryloyldimethyltaurate/VP Copolymer  
    INGR Pea  
    INGR Bambusa Vulgaris Top  
    INGR PEG-75 Stearate  
    INGR Xanthan Gum  
    INGR Pullulan  
    INGR Isohexadecane  
    INGR Citric Acid Monohydrate  
    INGR Potassium Sorbate  
    INGR Ceteth-20  
    INGR Decyl Glucoside  
    INGR Steareth-20  
    INGR Edetate Disodium  
    INGR Phenoxyethanol  
    INGR Hyaluronate Sodium  
    INGR Narcissus Tazetta Bulb  
    INGR Schisandra Chinensis Fruit  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 30 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Cosmetic 05/01/2013
    Part 4 of 4
    AGELOC TRANSFORMING NIGHT 
    night cream
    Product Information
    Route of Administration TOPICAL DEA Schedule     
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    INGR Water  
    INGR Glycerin  
    INGR Pentylene Glycol  
    INGR Caprylyl Trisiloxane  
    INGR Cyclomethicone 5  
    INGR Shea Butter  
    INGR Medium-Chain Triglycerides  
    INGR Ammonium Acryloyldimethyltaurate/VP Copolymer  
    INGR Sorbitol  
    INGR Chlorphenesin  
    INGR Glucosamine Hydrochloride  
    INGR Squalane  
    INGR Xanthan Gum  
    INGR Pea  
    INGR Edetate Sodium  
    INGR Bambusa Vulgaris Top  
    INGR Narcissus Tazetta Bulb  
    INGR Citric Acid Monohydrate  
    INGR Schisandra Chinensis Fruit  
    INGR Hyaluronate Sodium  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 30 mL in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Cosmetic 05/01/2013
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 05/01/2013
    Labeler - NSE Products, Inc. (803486393)
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