MEDIKOII BIO-UV PROTECT LASER MASTER- ethylhexyl methoxycinnamate, isoamyl p-methoxycinnamate, diethylamino hydroxybenzoyl hexyl

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20) (DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE - UNII:ANQ870JD20), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), AMILOXATE (UNII: 376KTP06K8) (AMILOXATE - UNII:376KTP06K8), BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH)
Available from:
Theranotics Co., LTD.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Skin protectant Apply proper amount to the skin.
Authorization status:
OTC monograph not final
Authorization number:
72695-0004-1

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.

----------

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

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 T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:726 9 5-0 0 0 4

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DIETHYLAMINO HYDRO XYBENZO YL HEXYL BENZO ATE (UNII: ANQ8 70 JD20 )

(DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE - UNII:ANQ8 70 JD20 )

DIETHYLAMINO

HYDROXYBENZOYL HEXYL

BENZOATE

in 10 0 mL

O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

OCTISALATE

in 10 0 mL

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

in 10 0 mL

Theranotics Co., LTD.

AMILO XATE (UNII: 376 KTP0 6 K8 ) (AMILOXATE - UNII:376 KTP0 6 K8 )

AMILOXATE

in 10 0 mL

BEMO TRIZINO L (UNII: PWZ1720 CBH) (BEMOTRIZINOL - UNII:PWZ1720 CBH)

BEMOTRIZINOL

1.5 g

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

ADENO SINE (UNII: K72T3FS56 7)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:726 9 5-

0 0 0 4-1

50 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

10 /0 1/20 18

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

10 /0 1/20 18

Labeler -

T heranotics Co., LT D. (694963085)

Registrant -

T heranotics Co., LT D. (694963085)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

DERMAMEAL CO., LTD.

6 9 4253327

ma nufa c ture (726 9 5-0 0 0 4)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Therano tics Co ., LTD.

6 9 49 6 30 8 5

re la be l(726 9 5-0 0 0 4)

Revised: 3/2019

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