MEDIKOII BIO-UV PROTECT LASER MASTER- ethylhexyl methoxycinnamate, isoamyl p-methoxycinnamate, diethylamino hydroxybenzoyl hexyl benzoate, ethylhexyl salicylate, bis-ethylhexyloxyphenol methoxyphenyl triazine cream 
Theranotics Co., LTD.

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

ETHYLHETYL METHOXYCINNAMATE, ISOAMYL P-METHOXYCINNAMATE, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, ETHYLHEXYL SALICYLATE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE

Water, Niacinamide, Adenosine, etc.

Skin protectant

keep out of reach of the children

Apply proper amount to the skin.

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


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MEDIKOII BIO-UV PROTECT LASER MASTER 
ethylhexyl methoxycinnamate, isoamyl p-methoxycinnamate, diethylamino hydroxybenzoyl hexyl benzoate, ethylhexyl salicylate, bis-ethylhexyloxyphenol methoxyphenyl triazine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72695-0004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20) (DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE - UNII:ANQ870JD20) DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE3 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 mL
AMILOXATE (UNII: 376KTP06K8) (AMILOXATE - UNII:376KTP06K8) AMILOXATE4 g  in 100 mL
BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH) BEMOTRIZINOL1.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ADENOSINE (UNII: K72T3FS567)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72695-0004-150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/201804/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/201804/01/2020
Labeler - Theranotics Co., LTD. (694963085)
Registrant - Theranotics Co., LTD. (694963085)
Establishment
NameAddressID/FEIBusiness Operations
Theranotics Co., LTD.694963085manufacture(72695-0004)

Revised: 4/2020
 
Theranotics Co., LTD.