PREMIUM ULTRA UV PURE SUN- octocrylene, ethylhexyl methoxycinnamate, diethylamino hydroxybenzoyl hexyl benzoate, ethylhexyl salicylate, bis-ethylhexyloxyphenol methoxyphenyl triazine stick

PREMIUM ULTRA UV PURE SUN by

Drug Labeling and Warnings

PREMIUM ULTRA UV PURE SUN by is a Otc medication manufactured, distributed, or labeled by Purecell Korea Co., Ltd., Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Octocrylene, Ethylhexyl Methoxycinnamate, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Ethylhexyl Salicylate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine

INACTIVE INGREDIENT

Water, Butylene Glycol, etc.

PURPOSE

Sunscreen

KEEP OUT OF REACH OF CHILDREN

keep out or reach of the children

INDICATIONS & USAGE

During the last step of basic skin care, dispense an appropriate amount and evenly apply to any skn that will be exposed to ultraviolet sunlight.

WARNINGS

Do not use on damaged or broken skin.

When using this product
Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use if following symptoms occur. (Continuing in usage may increase symptoms, ask doctor.)

1) If any red spots, swelling, itching, or skin irritation develops.

2) If direct sunlight causes irritation

Keep out of reach of children
Do not swallow. In case of accidental ingestion, get medical help or contact a Poison Control

Center right away.

Store at room temperature
Close lid after use – possibility of contamination may exists if displaced contents are replaced back to container.

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PREMIUM ULTRA UV PURE SUN 
octocrylene, ethylhexyl methoxycinnamate, diethylamino hydroxybenzoyl hexyl benzoate, ethylhexyl salicylate, bis-ethylhexyloxyphenol methoxyphenyl triazine stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71609-0009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 g
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20) (DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE - UNII:ANQ870JD20)	DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE	7 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH)	BEMOTRIZINOL	2 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 g  in 100 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71609-0009-1	15 g in 1 CONTAINER; Type 0: Not a Combination Product	06/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2017

Labeler - Purecell Korea Co., Ltd. (694667185)

Registrant - Purecell Korea Co., Ltd. (694667185)

Establishment
Name	Address	ID/FEI	Business Operations
Purecell Korea Co., Ltd.		557799448	label(71609-0009)

Establishment
Name	Address	ID/FEI	Business Operations
Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory		688235645	manufacture(71609-0009)