LABODE DERMAFIRM SUN DEFENSE MAKE UP BASE- ethylhexyl methoxycinnamate, ethylhexyl salicylate, titanium dioxide, zinc oxide cream 
Dermafirm INC.

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.

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Dermafirm - LABODE DERMAFIRM SUN DEFENSE MAKE UP BASE (71638-0013)

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

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

Helps prevent sunburn.

Helps improve skin tone and keep moisturized.

keep out of reach of the children

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

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.

for external use only


label

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)

Revised: 12/2019
Document Id: 98d7e5df-e3ad-379b-e053-2995a90a41fa
Set id: 97a9d2ca-e817-e135-e053-2a95a90ae5c1
Version: 2
Effective Time: 20191203
 
Dermafirm INC.