ECO SOUL SKIN WEAR FOUNDATION N 02- titanium dioxide, octinoxate, zinc oxide cream 
The Saem International 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 ingredients: Titanium Dioxide 9.15%, Ethylhexyl Methoxycinnamate 4.00%, Zinc Oxide 3.84%

INACTIVE INGREDIENT

Inactive ingredients:

Eucalyptus Globulus Leaf Water, Cyclopentasiloxane, Cyclohexasiloxane, Glycerin, Butylene Glycol, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Polymethylsilsesquioxane, Niacinamide, Dimethicone, Sodium Chloride, Phenyl Trimethicone, Pentylene Glycol, CI 77492, Synthetic Fluorphlogopite, Water, Aluminum Hydroxide, Cetyl PEG/PPG-10/1 Dimethicone, Polyglyceryl-4 Isostearate, PEG-10 Dimethicone, Poly C10-30 Alkyl Acrylate, Butylene Glycol Dicaprylate/Dicaprate, Hexyl Laurate, Stearic Acid, Panthenol, Disteardimonium Hectorite, Dimethicone/Vinyl Dimethicone Crosspolymer, Sorbitan Sesquioleate, Alumina, Silica, Sodium Benzoate, CI 77491, Phenoxyethanol, Hydrogen Dimethicone, Dimethiconol, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Acrylates/Dimethicone Copolymer, Fragrance, Disodium stearoyl glutamate, Polyhydroxystearic Acid, Potassium Sorbate, Propylene Carbonate, Butyl Avocadate, CI 77499, Disodium EDTA, Adenosine, Lecithin, Ethylhexyl Palmitate, Isopropyl Palmitate, Isostearic Acid, Triethoxycaprylylsilane, Phyllostachis Bambusoides Juice, Betula Platyphylla Japonica Juice, Chamaecyparis Obtusa Water, Polyglyceryl-3 Polyricinoleate, Alcohol, Caprylic/Capric Triglyceride, Saccharide Isomerate, Polyglutamic Acid, Macadamia Ternifolia Seed Oil, TEA-cocoyl Glutamate, Ceramide NP, Creatine, PEG-5 Rapeseed Sterol, Beta-Sitosterol, Cholesterol, Brassica Campestris (Rapeseed) Sterols, Hydrogenated Lecithin, Choleth-24, Ceteth-24, Sodium Hyaluronate, BHT, Cetyl Phosphate, Sodium Ascorbyl Phosphate, Ethylhexylglycerin, Propyl Gallate

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:

For external use only

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.

4. Keep out of reach of babies and children.

DESCRIPTION

Uses:

Helps prevent sunburn.

Directions:

Use after skincare routine. Apply an appropriate amount evenly on the face along skin's texture and gently tap for better coverage.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

ECO SOUL SKIN WEAR FOUNDATION N 02 
titanium dioxide, octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70341-650
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide2.74 g  in 30 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate1.20 g  in 30 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.15 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70341-650-021 in 1 CARTON05/01/201811/01/2019
1NDC:70341-650-0130 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/01/201811/01/2019
Labeler - The Saem International Co., Ltd. (689402402)
Registrant - The Saem International Co., Ltd. (689402402)
Establishment
NameAddressID/FEIBusiness Operations
Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory688235645manufacture(70341-650)

Revised: 12/2019
 
The Saem International Co., Ltd.