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

ETHYLHEXYL METHOXYCINNAMATE, ZINC OXIDE, ETHYLHEXYL SALICYLATE, TITANIUM DIOXIDE, ISOAMYL P-METHOXYCINNAMATE

Water, Cyclopentasiloxane, etc.

Sunscreen

keep out of reach of the children

▶ After basic skin care, apply on entire face and neck.
▶ Apply before sun exposure.
▶ Apply often to sun-sensitive areas

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

for external use only


1

DERMAFIRM SUNBLOCK 
ethylhexyl methoxycinnamate, zinc oxide, ethylhexyl salicylate, titanium dioxide, isoamyl p-methoxycinnamate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71638-0013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.9 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.15 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
AMILOXATE (UNII: 376KTP06K8) (AMILOXATE - UNII:376KTP06K8) AMILOXATE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71638-0013-150 mL in 1 TUBE; Type 0: Not a Combination Product04/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/01/201806/10/2021
Labeler - Dermafirm INC. (690171603)

Revised: 6/2021
 
Dermafirm INC.