Label: DERMESSE SUNSCREEN SPF30 MEDIUM TINT- octinoxate, zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 July 12, 2021

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  • ​Active Ingredients

    Octinoxiate 7.5% w/w

    Zinc Oxide 7% w/w

  • ​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 aging caused by the sun.

  • ​Warnings:

    ​For external use only​

    Do not use on damaged or broken skin.

  • When using this product:

    • Keep out of eyes.  Rinse with water to remove.

  • Stop use and ask doctor if

    • Rash or irritation develops

  • 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

    • Reapply

       • After 40 minutes of swimming or sweating

       • Immediately after towel drying

       • At least every 2 hours

    • 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 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 long sleeve shirts, pants, hats, and sunglasses

  • ASK DOCTOR

    ​Children under 6 months: ​Ask a doctor

  • ​Inactive Ingredients

    Water, Cyclomethicone, C12-15 Alkyl Benzoate, C18-38 Alkyl Hydroxystearoyl Stearate, Hexylene Glycol, Aloe Barbadensis Leaf Extract, PEG-40 Stearate, Glycerin, Aluminum Starch Octenylsuccinate, Carnauba Wax, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, PEG100 Stearate, Squalane, Tocopheryl Acetate, Propylene Glycol, Siliconyl Beeswax, Stearoxytrimethylsilane, Green Tea (Camellia Sinensis) Leaf Extract, Glyceryl Dilaurate, Dimethicone, Glyceryl Stearate, Cetearyl Alcohol, Stearyl Alcohol, Steareth-100, Titanium Dioxide, Sorbitan Tristearate, Ceteareth-20, VP/Eicosene Copolymer, Polysorbate-60, Beheneth-5, Triethoxycaprylylsilane, Caprylyl Glycol, Fragrance, Methylisothiazolinone, Iron Oxides: Yellow (C177492), Red (C177491), Black (C177499)

  • ​Other information

    ​Protect this product from excessive heat and direct sun.

  • ​Questions or Comments?

    866-494-4466 or visit www.dermesse.com

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    DERMESSE SUNSCREEN SPF30 MEDIUM TINT 
    octinoxate, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68723-331
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE70 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    SQUALANE (UNII: GW89575KF9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BIS-PEG-12 DIMETHICONE (500 MPA.S) (UNII: 2CNS542YRT)  
    STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    GLYCERYL DILAURATE (UNII: MFL3ZIE8SK)  
    DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    CETEARYL STEARATE (UNII: 9T97Q8P3CK)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    STEARETH-100 (UNII: 4OH5W9UM87)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SORBITAN TRISTEARATE (UNII: 6LUM696811)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    BEHENETH-5 (UNII: L4A971L76E)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68723-331-0257 g in 1 BOTTLE; Type 0: Not a Combination Product05/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35205/01/2015
    Labeler - Axia Medical Solutions, LLC (929224694)
    Registrant - Axia Medical Solutions, LLC (929224694)
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