Label: DERMAFIRM SUNBLOCK- ethylhexyl methoxycinnamate, zinc oxide, ethylhexyl salicylate, titanium dioxide, isoamyl p-methoxycinnamate cream

  • 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 May 28, 2018

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  • ACTIVE INGREDIENT

    ETHYLHEXYL METHOXYCINNAMATE, ZINC OXIDE, ETHYLHEXYL SALICYLATE, TITANIUM DIOXIDE, ISOAMYL P-METHOXYCINNAMATE

  • INACTIVE INGREDIENT

    Water, Cyclopentasiloxane, etc.

  • PURPOSE

    Sunscreen

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    ▶ After basic skin care, apply on entire face and neck.
    ▶ Apply before sun exposure.
    ▶ Apply often to sun-sensitive areas

  • WARNINGS

    1. Do not use in the following cases(Eczema and scalp wounds)
    2.Side Effects
    1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor
    3.General Precautions
    1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately
    2)This product is for exeternal use only. Do not use for internal use
    4.Storage and handling precautions
    1)If possible, avoid direct sunlight and store in cool and area of low humidity
    2)In order to maintain the quality of the product and avoid misuse
    3)Avoid placing the product near fire and store out in reach of children

  • DOSAGE & ADMINISTRATION

    for external use only


  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    DERMAFIRM SUNBLOCK 
    ethylhexyl methoxycinnamate, zinc oxide, ethylhexyl salicylate, titanium dioxide, isoamyl p-methoxycinnamate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71638-0013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.9 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.15 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    AMILOXATE (UNII: 376KTP06K8) (AMILOXATE - UNII:376KTP06K8) AMILOXATE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71638-0013-150 mL in 1 TUBE; Type 0: Not a Combination Product04/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/01/2018
    Labeler - Dermafirm INC. (690171603)
    Registrant - Dermafirm INC. (690171603)
    Establishment
    NameAddressID/FEIBusiness Operations
    EYESOME. Co.,Ltd.557795360manufacture(71638-0013)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dermafirm INC.690171603relabel(71638-0013)