Label: JANE SEYMOUR NATURAL ADVANTAGE AM SPF 15 ALL DAY MOISTURE WITH AHAS- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream

  • NDC Code(s): 70605-026-11, 70605-026-13, 70605-026-57
  • Packager: Guthy-Renker,LLC
  • Category: HUMAN OTC DRUG LABEL

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 February 2, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Fact Label

  • Active ingredient

    Avobenzone - 2.0%
    Homosalate - 10.0%
    Octisalate - 5.0%
    Octocrylene - 1.3%
    Oxybenzone - 4.0%

  • Purpose

    Sunscreen

  • Use

    • Helps prevents 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 eye. Rinse with water to remove.

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

    • 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.
    • Sun Protection 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 value 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.
  • Other information

    • Protect the product in this container from excessive heat and direct sunlight.
  • Inactive ingredients

    Water, Glycolic Acid, Glycerin, Steareth-20, PEG-100 Stearate, Hexyl Laurate, Dimethicone, Cetyl Alcohol, Steareth-2, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Ammonium Hydroxide, Potassium Cetyl Phosphate, Camellia Oleifera Leaf Extract, Tocopheryl Acetate, Ormenis Multicaulis Oil, Panthenol, Allantoin, Butylene Glycol, Bentonite, Glyceryl Stearate, Hydrogenated Palm Glycerides, Hydroxyethyl Acrylate/Sodium Acryloydimethyl Taurate Copolymer, Polyisobutene, PEG-7 Trimethylolpropane Coconut Ether, Xanthan Gum, Disodium EDTA, Phenoxyethanol, Ethylhexylglycerin, Chlorphenesin

  • Questions or comments?

    1-877-435-7383

  • PRINCIPAL DISPLAY PANEL - Tube Label

    AM

    All Day Moisture
    with AHAs
    SPF 15
    Broad Spectrum
    Sunscreen

    Active
    Ingredients
    Avobenzone 2.0%
    Homosalate 10.0%
    Octisalate 5.0%
    Octocrylene 1.3%
    Oxybenzone 4.0%

    M050597

    Peel here for
    Drug Facts
    Information

    PRINCIPAL DISPLAY PANEL - Tube Label
  • INGREDIENTS AND APPEARANCE
    JANE SEYMOUR NATURAL ADVANTAGE AM SPF 15 ALL DAY MOISTURE WITH AHAS 
    avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70605-026
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone2 mg  in 100 mL
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate10 mg  in 100 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate5 mg  in 100 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene1.3 mg  in 100 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone4 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycolic Acid (UNII: 0WT12SX38S)  
    Glycerin (UNII: PDC6A3C0OX)  
    AMMONIA (UNII: 5138Q19F1X)  
    Steareth-20 (UNII: L0Q8IK9E08)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Hexyl Laurate (UNII: 4CG9F9W01Q)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Steareth-2 (UNII: V56DFE46J5)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    Allantoin (UNII: 344S277G0Z)  
    Panthenol (UNII: WV9CM0O67Z)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    BENTONITE (UNII: A3N5ZCN45C)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70605-026-1350 mL in 1 TUBE; Type 0: Not a Combination Product12/30/2017
    2NDC:70605-026-5750 mL in 1 TUBE; Type 0: Not a Combination Product12/30/201711/18/2020
    3NDC:70605-026-1130 mL in 1 TUBE; Type 0: Not a Combination Product12/30/201711/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35212/30/2017
    Labeler - Guthy-Renker,LLC (948861877)
    Establishment
    NameAddressID/FEIBusiness Operations
    AMCOL HEALTH AND BEAUTY SOLUTIONS INC872684803MANUFACTURE(70605-026)
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