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

Image of carton

CLAPIEL DEFENSE SUNBLOCK 
octinoxate, zinc oxide, octisalate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69977-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.4 mg  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2.5 mg  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.25 mg  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.0 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Dipropylene Glycol (UNII: E107L85C40)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69977-050-0150 mL in 1 CARTON; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/01/2015
Labeler - AUS KOREA CO., LTD. (689515251)
Registrant - AUS KOREA CO., LTD. (689515251)
Establishment
NameAddressID/FEIBusiness Operations
AUS KOREA CO., LTD.689515251manufacture(69977-050)

Revised: 7/2015
Document Id: 3173e183-37cc-49ae-a61b-09165c24d6b0
Set id: 6c2e804c-ea39-4771-8ff6-c6ff93234794
Version: 1
Effective Time: 20150724
 
AUS KOREA CO., LTD.