JANE SEYMOUR NATURAL ADVANTAGE AM SPF 15 ALL DAY MOISTURE WITH AHAS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [GUTHY-RENKER,LLC]

  • Home
  • JANE SEYMOUR NATURAL ADVANTAGE AM SPF 15 ALL DAY MOISTURE WITH AHAS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [GUTHY-RENKER,LLC]

JANE SEYMOUR NATURAL ADVANTAGE AM SPF 15 ALL DAY MOISTURE WITH AHAS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [GUTHY-RENKER,LLC]
PDF | XML
NDC 70605-026-11, 70605-026-13, 70605-026-57
Set ID 76298090-e873-4307-8bdb-19cdab6d9ac2
Category HUMAN OTC DRUG LABEL
Packager Guthy-Renker,LLC
Generic Name
Product Class
Product Number
Application Number PART352
View All Sections
  • 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)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70605-026-1350 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product12/30/2017
    2NDC:70605-026-5750 mL in 1 TUBE; Type 0: Not a Combination Product12/30/2017
    3NDC:70605-026-1130 mL in 1 TUBE; Type 0: Not a Combination Product12/30/2017
    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
    Paklab (AKA Diversapak of California/Universal Packaging Sysytem, Inc)790530976MANUFACTURE(70605-026)
    Establishment
    NameAddressID/FEIBusiness Operations
    Thibiant International, Inc.083913913MANUFACTURE(70605-026)
View All Sections

Related Drugs

Search DailyMed Drugs