FASCY LAB GREEN PLUS SUN- diethylamino hydroxybenzoyl hexyl benzoate, bemotrizinol cream

FASCY LAB GREEN PLUS SUN by

Drug Labeling and Warnings

FASCY LAB GREEN PLUS SUN by is a Otc medication manufactured, distributed, or labeled by FASCY Co,.LTD., Greencos Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: 

DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE 2.0%
BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE 1.0%

INACTIVE INGREDIENT

Inactive Ingredients:

WATER, BUTYLENE GLYCOL, C12-15 ALKYL BENZOATE, METHYL METHACRYLATE CROSSPOLYMER, 1,2-HEXANEDIOL, NIACINAMIDE, BEHENYL ALCOHOL, POTASSIUM CETYL PHOSPHATE, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, POLYISOBUTENE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, SILICA, ADENOSINE, CAPRYLYL/CAPRYL GLUCOSIDE, DISODIUM EDTA, SORBITAN OLEATE, SODIUM HYALURONATE

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: 

1) In case of any abnormal symptoms or side effects such as redness, swelling or itching during and after use, consult a specialist.
2) Avoid using in injured areas.
3) Storage and handling cautions: a) keep away from children, b) keep away from direct sunlight.
4) For external use only

KEEP OUT OF REACH OF CHILDREN

keep away from children

Uses

Uses
Helps prevent sunburn.

Directions

Directions
Apply thoroughly on parts of your skin exposed to the sun.
Reapply often (every 2 hours) and after swimming, excessive perspiration and washing to ensure maximum sun protection.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FASCY LAB GREEN PLUS SUN 
diethylamino hydroxybenzoyl hexyl benzoate, bemotrizinol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70991-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20) (DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE - UNII:ANQ870JD20)	DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE	1.0 g  in 50 mL
BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH)	BEMOTRIZINOL	0.5 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
NIACINAMIDE (UNII: 25X51I8RD4)
DOCOSANOL (UNII: 9G1OE216XY)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ADENOSINE (UNII: K72T3FS567)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70991-200-02	1 in 1 CARTON	04/01/2020
1	NDC: 70991-200-01	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/01/2020

Labeler - FASCY Co,.LTD. (689204222)

Registrant - FASCY Co,.LTD. (689204222)

Establishment
Name	Address	ID/FEI	Business Operations
Greencos Co., Ltd.		694777325	manufacture(70991-200)