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

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

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Active ingredient:
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37), HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)
Available from:
BNHCOSMETICS CO.,LTD.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose: Sunscreen
Authorization status:
OTC monograph not final
Authorization number:
71597-060-01, 71597-060-02

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.

----------

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

ACWELL UV CUT WATERPROOF SUN

zinc oxide, homosalate, octisalate, titanium dioxide cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7159 7-0 6 0

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8 SF37)

ZINC CATION

4.6 5 g in 50 g

HO MO SALATE (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S)

HOMOSALATE

3.0 0 g in 50 g

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

OCTISALATE

2.0 0 g in 50 g

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

0 .6 5 g in 50 g

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7159 7-0 6 0 -0 2 1 in 1 CARTON

0 8 /0 1/20 19

1

NDC:7159 7-0 6 0 -0 1 50 g in 1 CONTAINER; Type 0 : No t a Co mbinatio n Pro duct

BNHCOSMETICS CO.,LTD.

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

0 8 /0 1/20 19

Labeler -

BNHCOSMET ICS CO.,LT D. (688404819)

Registrant -

BNHCOSMET ICS CO.,LT D. (688404819)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ko lmar Ko rea Co .,LTD. Gwanjeo ng Facto ry

6 8 9 5126 11

ma nufa c ture (7159 7-0 6 0 )

Revised: 9/2019

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