Label: EPIONCE ULTRA SHIELD- homosalate, octisalate, zinc oxide lotion

  • NDC Code(s): 42673-011-00, 42673-011-01, 42673-011-02, 42673-011-03, view more
    42673-011-04, 42673-011-05
  • Packager: Episciences, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 September 20, 2022

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  • Active ingredients

    Homosalate 9.95%

    Octisalate 5.0%

    Zinc Oxide 10.1%

  • 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

    • apply liberally 15 minutes before sun exposure
    • reapply:
      • after 80 minutes of swimming or sweating
      • immediately after towel drying
      • at least every two 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. - 2 p.m.
      • wear long-sleeved shirts, pants, hats and sunglasses
  • Other information

    • protect this product from excessive heat and direct sun

  • Inactive ingredients

    Alkyl (C12-15) Benzoate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Butylene Glycol, Caprylyl Glycol, Caprylyl Trisiloxane, Cetostearyl Alcohol, Date, Dimethicone, Ethylhexylglycerin, Glycerin, Hexylene Glycol, Hydrogenated Polybutene (1300 MW), Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (4500 MPA.S AT 1%), Linseed Oil, Malic Acid, Meadowfoam Seed Oil, Phenoxyethanol, Polyhydroxystearic Acid (2300 MW), Polysorbate 80, Safflower Oil, Steareth-2, Steareth-21, Triethoxycaprylylsilane, Trimethylsiloxysilicate (M/Q 0.66), Water.

  • Questions?

    Call toll free 1-866-374-6623

  • Prinicipal Display Panel

    USL 2.5oz PDP

  • INGREDIENTS AND APPEARANCE
    EPIONCE ULTRA SHIELD 
    homosalate, octisalate, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42673-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.101 g  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.1 g  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.05 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    MALIC ACID (UNII: 817L1N4CKP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DATE (UNII: H3O7QI5HY7)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STEARETH-2 (UNII: V56DFE46J5)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    WATER (UNII: 059QF0KO0R)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    STEARETH-21 (UNII: 53J3F32P58)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42673-011-021 in 1 BOX04/06/200908/31/2024
    1NDC:42673-011-0175 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:42673-011-051 in 1 BOX04/06/200908/31/2024
    2NDC:42673-011-0430 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:42673-011-006 g in 1 TUBE; Type 0: Not a Combination Product04/06/200908/31/2024
    4NDC:42673-011-03454 g in 1 JAR; Type 0: Not a Combination Product04/06/200908/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/06/200908/31/2024
    Labeler - Episciences, Inc. (144733040)
    Establishment
    NameAddressID/FEIBusiness Operations
    Episciences, Inc.144733040manufacture(42673-011)
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