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

LABODE DERMAFIRM SUN DEFENSE MAKE UP BASE by

Drug Labeling and Warnings

LABODE DERMAFIRM SUN DEFENSE MAKE UP BASE by is a Otc medication manufactured, distributed, or labeled by Dermafirm INC., EYESOME. Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Product 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)