ACWELL UV CUT MILD SUN FLUID- titanium dioxide liquid

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

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Active ingredient:
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:
71597-050-01, 71597-050-02

ACWELL UV CUT MILD SUN FLUID- titanium dioxide liquid

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: TITANIUM DIOXIDE 7.99%

INACTIVE INGREDIENT

Inactive ingredients:

WATER, C12-15 ALKYL BENZOATE, PROPANEDIOL, BUTYLENE GLYCOL, CETYL

ETHYLHEXANOATE, 1,2-HEXANEDIOL, CAPRYLYL METHICONE, ALUMINUM STEARATE,

POLYMETHYLSILSESQUIOXANE, POLYHYDROXYSTEARIC ACID, BUTYLOCTYL

SALICYLATE, SILICA, PENTYLENE GLYCOL, CAPRYLIC/CAPRIC TRIGLYCERIDE,

ALUMINA, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VPCOPOLYMER, SACCHARIDE

HYDROLYSATE, POLYACRYLATE CROSSPOLYMER-6, BENZOTRIAZOLYL DODECYL P-

CRESOL, SODIUM STEAROYL GLUTAMATE, HYDROXYPROPYL METHYLCELLULOSE

STEAROXYETHER, GLYCERYL CAPRYLATE, STEARIC ACID, ETHYLHEXYLGLYCERIN,

LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, CITRUS PARADISI (GRAPEFRUIT) PEEL

OIL, PORTULACA OLERACEA EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF

OIL, SALVIA HISPANICA SEED EXTRACT, CENTELLA ASIATICA EXTRACT, HOUTTUYNIA

CORDATA EXTRACT, CURCUMA LONGA (TURMERIC) ROOT EXTRACT, HELIANTHUS

ANNUUS (SUNFLOWER) SEED OIL, T-BUTYL ALCOHOL, PERSEA GRATISSIMA

(AVOCADO) OIL, ANTHEMIS NOBILIS FLOWER OIL, CENTAUREA CYANUS FLOWER

WATER, GLYCERYL GLUCOSIDE, MALTODEXTRIN, HYDROLYZED VEGETABLE PROTEIN,

XYLITYLGLUCOSIDE, ANHYDROXYLITOL, XYLITOL, ANIBA ROSODORA (ROSEWOOD)

WOOD OIL, GLYCERIN, GLUCOSE, ORIGANUM VULGARE LEAF EXTRACT,

CHAMAECYPARIS OBTUSA LEAF EXTRACT, SALIX ALBA (WILLOW) BARK EXTRACT,

LACTOBACILLUS/SOYBEAN FERMENT EXTRACT, CINNAMOMUM CASSIA BARK

EXTRACT, SCUTELLARIA BAICALENSIS ROOT EXTRACT

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:

A physical sunscreen contained active mineral ingredients which mainly works by sitting on top of the

skin to deflect and scatter damaging UVA rays away from the skin and helps prevent sunburn.

Directions:

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BNHCOSMETICS CO.,LTD.

ACWELL UV CUT MILD SUN FLUID

titanium dioxide liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7159 7-0 50

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

TITANIUM DIOXIDE

11.18 g in 140 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

PRO PANEDIO L (UNII: 59 6 5N8 W8 5T)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:7159 7-0 50 -

1 in 1 CARTON

0 8 /0 1/20 19

1

NDC:7159 7-0 50 -

140 mL in 1 CONTAINER; Type 0 : No t a Co mbinatio n

Pro duc t

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 50 )

Revised: 9/2019

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