ECO BARRIER NON CHEMICAL SUN- zinc oxide, titanium dioxide cream 
JEIL H&B INC.

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 ingredients: Zinc Oxide 10%, Titanium Dioxide 8%

INACTIVE INGREDIENT

Inactive ingredients: Water, Cyclomethicone, Propanediol, Dicaprylyl Carbonate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Cetyl Ethylhexanoate, Aluminum Hydroxide, 1,2-Hexanediol, Disteardimonium Hectorite, Hydrogen Dimethicone, Magnesium Sulfate, Salvia Hispanica Seed Extract, Stearic Acid, Centella Asiatica Extract, Houttuynia Cordata Extract, Polyglyceryl-2 Dipolyhydroxystearate, Dimethicone Crosspolymer, Phenyl Trimethicone, Lavandula Angustifolia (Lavender) Oil, Fructooligosaccharides, Saccharide Hydrolysate, Pullulan, Water, Ethylhexylglycerin, Octyldodecanol, Hydrogenated Lecithin, Echium Plantagineum Seed Oil, Cetearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Butylene Glycol, Caprylyl Glycol, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Sorbitan Sesquioleate, Cholesterol, Phytosphingosine, Ceramide EOP, Ceramide NS, Ceramide NP, Ceramide AP, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Chamomilla Recutita (Matricaria) Flower Oil, Tocopherol, Hyaluronic Acid, Hydrolyzed Hyaluronic Acid, Sodium Hyaluronate

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Keep out of reach of children.

DESCRIPTION

Uses: Hypoallergenic sun cream for children and easily irritated sensitive skin. The natural 100% mineral filter forms a physical barrier to reflect UV light from the surface of the skin. With a skin-friendly moisturizing formula, this sun cream smoothes into the skin easily and protects the skin from external stimuli like fine dust. This mild sun cream is suitable for all skin types, decreases the risk of skin cancer and early skin aging caused by the sun.

Directions:

Apply liberally 15 minutes before sun exposure

Reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeve shirts, pants, hats and sunglasses

Children under 6 months: Ask a doctor

Questions: www.nislcos.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

ECO BARRIER NON CHEMICAL SUN 
zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71982-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION5.0 g  in 50 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide4.0 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Propanediol (UNII: 5965N8W85T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71982-010-021 in 1 CARTON12/01/2017
1NDC:71982-010-0150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/01/2017
Labeler - JEIL H&B INC. (694788123)
Registrant - JEIL H&B INC. (694788123)
Establishment
NameAddressID/FEIBusiness Operations
COSON Co., Ltd._Osan Plant689847210manufacture(71982-010)

Revised: 1/2018
Document Id: 9f56cf81-d319-4c6e-81a1-7e1207ea4269
Set id: 8bb05876-d3c4-4fcd-9c56-573471d9c9b0
Version: 1
Effective Time: 20180110
 
JEIL H&B INC.