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

----------

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

Water, Butylene Glycol, etc.

Sunscreen

keep out or reach of the children

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.

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.

for external use only


1

PREMIUM ULTRA UV PURE SUN 
octocrylene, ethylhexyl methoxycinnamate, diethylamino hydroxybenzoyl hexyl benzoate, ethylhexyl salicylate, bis-ethylhexyloxyphenol methoxyphenyl triazine stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71609-0009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 g
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20) (DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE - UNII:ANQ870JD20) DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE7 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH) BEMOTRIZINOL2 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71609-0009-115 g in 1 CONTAINER; Type 0: Not a Combination Product06/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/2017
Labeler - Purecell Korea Co., Ltd. (694667185)
Registrant - Purecell Korea Co., Ltd. (694667185)
Establishment
NameAddressID/FEIBusiness Operations
Purecell Korea Co., Ltd.557799448label(71609-0009)
Establishment
NameAddressID/FEIBusiness Operations
Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory688235645manufacture(71609-0009)

Revised: 8/2017
Document Id: 56375b26-8b45-74c8-e054-00144ff88e88
Set id: 56379c3c-8622-0508-e054-00144ff8d46c
Version: 1
Effective Time: 20170808
 
Purecell Korea Co., Ltd.