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

Dermafirm Sunblock by

Drug Labeling and Warnings

Dermafirm Sunblock 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, 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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71638-0013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.9 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.15 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
AMILOXATE (UNII: 376KTP06K8) (AMILOXATE - UNII:376KTP06K8)	AMILOXATE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71638-0013-1	50 mL in 1 TUBE; Type 0: Not a Combination Product	04/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/01/2018

Labeler - Dermafirm INC. (690171603)

Registrant - Dermafirm INC. (690171603)

Establishment
Name	Address	ID/FEI	Business Operations
EYESOME. Co.,Ltd.		557795360	manufacture(71638-0013)

Establishment
Name	Address	ID/FEI	Business Operations
Dermafirm INC.		690171603	relabel(71638-0013)