KOCOSTAR SUN BLOCK CAPSULE MASK- octinoxate, octisalate, titanium dioxide liquid

Kocostar Sun Block Capsule Mask by

Drug Labeling and Warnings

Kocostar Sun Block Capsule Mask by is a Otc medication manufactured, distributed, or labeled by Natuzen Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: ETHYLHEXYL METHOXYCINNAMATE 7.5%, ETHYLHEXYL SALICYLATE 5.0%, TITANIUM DIOXIDE 3.5%

INACTIVE INGREDIENT

Inactive ingredients:
Dimethicone, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Polymethylsilsesquioxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Isoamyl p-Methoxycinnamate, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone Crosspolymer, Aluminum Stearate, Alumina, Polyhydroxystearic Acid, Phenoxyethanol, Fragrance, Tocopheryl Acetate, Limonene, Linalool, Hexyl Cinnamal, Salicornia Herbacea Extract, Phragmites Communis Extract, Benzyl Benzoate, Butylphenyl Methylpropional, Citronellol, Butylene Glycol, Glycerin, Benzyl Alcohol, Citral, Benzyl Salicylate, 1,2-Hexanediol

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:
● For external use only.
● Use as directed.
● Stop using the product and consult a dermatologist or physician if the following occurs: -swelling, red (strawberry) marks, or other abnormalities -itchiness due to indirect or direct exposure to light
● Do not apply to open wounds, eczema, or dermatitis.
● Avoid contact with eyes. if contact occurs, flush eyes thoroughly with clean and warm water.

DESCRIPTION

Uses:
Protect your skin from the Sun

Directions:
1. Twist off the tip of a heart-shaped sunscreen capsule.
2. Squeeze some amount of serum onto a fingertip.
3. Apply the serum to the skin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KOCOSTAR SUN BLOCK CAPSULE MASK 
octinoxate, octisalate, titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70930-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.13 g  in 1.75 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.08 g  in 1.75 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.06 g  in 1.75 g

Inactive Ingredients
Ingredient Name	Strength
Dimethicone (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70930-105-02	7 in 1 PACKAGE	02/01/2020
1	NDC: 70930-105-01	1.75 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2020

Labeler - Natuzen Co.,Ltd. (688201272)

Registrant - Natuzen Co.,Ltd. (688201272)

Establishment
Name	Address	ID/FEI	Business Operations
Natuzen Co.,Ltd.		688201272	manufacture(70930-105)