ACWELL UV CUT WATERPROOF SUN- zinc oxide, homosalate, octisalate, titanium dioxide cream 
BNHCOSMETICS 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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ACTIVE INGREDIENT

Active ingredients: ZINC OXIDE 9.30%, HOMOSALATE 6.00%, ETHYLHEXYL SALICYLATE 4.00%, TITANIUM DIOXIDE 1.30%

INACTIVE INGREDIENT

Inactive ingredients:
WATER, CYCLOPENTASILOXANE, POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYLDIMETHICONE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, PROPYLHEPTYL CAPRYLATE, GLYCERIN, NIACINAMIDE, DIPROPYLENE GLYCOL, METHYL METHACRYLATE CROSSPOLYMER, DIETHYLAMINO HYDROXYBENZOYL HEXYLBENZOATE, BUTYLOCTYL SALICYLATE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYLTRIAZINE, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, 1,2-HEXANEDIOL, CALCIUM ALUMINUM BOROSILICATE, SORBITAN CAPRYLATE, POLYGLYCERYL-6 POLYRICINOLEATE, TRIETHOXYCAPRYLYLSILANE, MICA, STEARIC ACID, ALUMINUM HYDROXIDE, BUTYLENE GLYCOL, GLYCERYL CAPRYLATE, CYMBOPOGON MARTINI OIL, ETHYLHEXYLGLYCERIN, ADENOSINE, CITRUS PARADISI (GRAPEFRUIT) PEEL OIL, OLEA EUROPAEA (OLIVE) FRUIT OIL, PROPANEDIOL, MICHELIA ALBA LEAF OIL, PANTHENOL, ADANSONIA DIGITATA SEED OIL, SACCHARIDE HYDROLYSATE, SODIUM HYALURONATE, ALOE BARBADENSIS LEAF EXTRACT, MORINGA OLEIFERA SEED OIL, ANIBA ROSODORA (ROSEWOOD) WOOD OIL, POGOSTEMON CABLIN OIL, ANTHEMIS NOBILIS FLOWER EXTRACT, PROPYLENE GLYCOL, BAMBUSA ARUNDINACEA STEM EXTRACT, OENOTHERA BIENNIS (EVENING PRIMROSE) OIL, SALVIA HISPANICA SEED EXTRACT, CENTELLA ASIATICA EXTRACT, PORTULACA OLERACEA EXTRACT, HOUTTUYNIA CORDATA EXTRACT, CURCUMA LONGA (TURMERIC) ROOT EXTRACT, TOCOPHEROL, PENTYLENE GLYCOL, CALENDULA OFFICINALIS FLOWER EXTRACT, OXYGEN

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:
-For external use only
-Do not use on skin that is broken, irritated or eczema
-Stop using and consult with your doctor or dermatologist if any of the following signs or symptoms occur after using this product
-You experience redness, swelling, itchiness, irritation or other discomfort
-When the symptoms listed above occur after exposure to direct rays
-Directions for storage and handling
-Do not store in hot or cold temperatures, or under direct rays
- Avoid contact with eyes.
Please read the instructions carefully prior to use

DESCRIPTION

Uses:

Excellent function that won't be easily erased by water.
An activityproof function that lasts for a long time even in intense movements or sports, and helps prevent sunburn.

Directions:
Apply an adequate amount evenly on your skin commonly exposed to UV rays.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

ACWELL UV CUT WATERPROOF SUN 
zinc oxide, homosalate, octisalate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71597-060
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION4.65 g  in 50 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE3.00 g  in 50 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.00 g  in 50 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.65 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71597-060-021 in 1 CARTON08/01/201910/21/2020
1NDC:71597-060-0150 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/201910/21/2020
Labeler - BNHCOSMETICS CO.,LTD. (688404819)
Registrant - BNHCOSMETICS CO.,LTD. (688404819)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co.,LTD. Gwanjeong Factory689512611manufacture(71597-060)

Revised: 6/2021
 
BNHCOSMETICS CO.,LTD.