Label: LABODE DERMAFIRM SUN DEFENSE MAKE UP BASE- ethylhexyl methoxycinnamate, ethylhexyl salicylate, titanium dioxide, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71638-0014-1 - Packager: Dermafirm 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 December 3, 2019
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- ACTIVE INGREDIENT
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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
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LABODE DERMAFIRM SUN DEFENSE MAKE UP BASE
ethylhexyl methoxycinnamate, ethylhexyl salicylate, titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71638-0014 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.96 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4.15 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71638-0014-1 30 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 11/18/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/18/2019 Labeler - Dermafirm INC. (690171603) Registrant - Dermafirm INC. (690171603) Establishment Name Address ID/FEI Business Operations EYESOME. Co.,Ltd. 557795360 manufacture(71638-0014)