CLAPIEL DEFENSE SUNBLOCK- octinoxate, zinc oxide, octisalate, titanium dioxide cream

Clapiel Defense Sunblock by

Drug Labeling and Warnings

Clapiel Defense Sunblock by is a Otc medication manufactured, distributed, or labeled by AUS KOREA CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: ETHYLHEXYL METHOXYCINNAMATE 6.80%, ZINC OXIDE 5.00%, ETHYLHEXYL SALICYLATE 4.50%, TITANIUM DIOXIDE 4.00%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Cyclopentasiloxane, Dipropylene Glycol, Peg-10 Dimethicone, Dicaprylyl Carbonate, Niacinamide, Disteardimonium Hectorite, Dimethicone, Magnesium Sulfate, Aluminum Hydroxide, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Phenoxyethanol, Viscum Album (Mistletoe) Leaf Extract, Centella Asiatica Extract, Portulaca Oleracea Extract, Stearic Acid, Fragrance, Polymethylsilsesquioxane, Methicone, Caprylyl Glycol, Dimethicone/Vinyl Dimethicone Crosspolymer, PEG-9 Plydimethylsiloxyethyl Dimethicone, Actinidia Chinensis (Kiwi) Fruit Extract, Camellia Sinensis Callus Culture Extract, Cucurbita Pepo (Pumpkin) Fruit Extract, Daucus Carota Sativa (Carrot) Root Extract, Glyceryl Caprylate, Mangifera Indica (Mango) Fruit Extract, Polyglyceryl-6 Plyricinoleate, Tocopheryl Acetate, Sodium Hyaluronate

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: 1. In case of having following symptoms after using this, you’re advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.

Keep out of reach of children: Keep out of reach of babies and children

DESCRIPTION

Indications & Usage: Apply a desired amount evenly over entire face.

Dosage & Administration: Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLAPIEL DEFENSE SUNBLOCK 
octinoxate, zinc oxide, octisalate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69977-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.4 mg  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	2.5 mg  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.25 mg  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.0 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Dipropylene Glycol (UNII: E107L85C40)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69977-050-01	50 mL in 1 CARTON; 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	05/01/2015

Labeler - AUS KOREA CO., LTD. (689515251)

Registrant - AUS KOREA CO., LTD. (689515251)

Establishment
Name	Address	ID/FEI	Business Operations
AUS KOREA CO., LTD.		689515251	manufacture(69977-050)