Label: LABODE DERMAFIRM SUN DEFENSE MAKE UP BASE- ethylhexyl methoxycinnamate, ethylhexyl salicylate, titanium dioxide, zinc oxide 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 December 3, 2019

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  • ACTIVE INGREDIENT

    Ethylhexyl Methoxycinnamate(Octinoxate), Ethylhexyl Salicylate(Octisalate), Titanium Dioxide, Zinc Oxide

  • INACTIVE INGREDIENT

    Water, Propylene Glycol, Cyclohexasiloxane, Butylene Glycol, Polyglyceryl-4 Isostearate, PEG-10 Dimethicone, Hydrogenated Poly(C6-14 Olefin), Cetyl PEG/PPG-10/1 Dimethicone, Cetyl Ethylhexanoate, Betaine, Cyclomethicone, Magnesium Sulfate, Disteardimonium Hectorite, Methyl Methacrylate Crosspolymer, Aluminum Hydroxide, Stearic Acid, Caprylyl Glycol, Dextrin Palmitate, Dimethicone Crosspolymer, Phenyl Trimethicone, Sodium Guaiazulene Sulfonate, Glycerin, Caprylhydroxamic Acid, Allantoin, Aloe Barbadensis Leaf Juice, Perilla Ocymoides Leaf Extract, Phenoxyethanol, Biosaccharide Gum-4, Citric Acid, Potassium Sorbate, Sodium Benzoate, Fragrance

  • PURPOSE

    Helps prevent sunburn.

    Helps improve skin tone and keep moisturized.

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    After the basic skincare routine, apply a suitable amount and gently spread.

  • WARNINGS

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash or irritation develops and lasts.

  • DOSAGE & ADMINISTRATION

    for external use only


  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    LABODE DERMAFIRM SUN DEFENSE MAKE UP BASE 
    ethylhexyl methoxycinnamate, ethylhexyl salicylate, titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71638-0014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.96 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.15 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71638-0014-130 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product11/18/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/18/2019
    Labeler - Dermafirm INC. (690171603)
    Registrant - Dermafirm INC. (690171603)
    Establishment
    NameAddressID/FEIBusiness Operations
    EYESOME. Co.,Ltd.557795360manufacture(71638-0014)
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