THE SAEM FOUNDATION 02 MEDIUM- titanium dioxide, zinc oxide, octinoxate, octisalate powder 
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 12.82%, Zinc Oxide 5.76%, Ethylhexyl Methoxycinnamate 5.50%, Ethylhexyl Salicylate 4.00%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Phenyl Trimethicone, Butylene Glycol, Cyclopentasiloxane, Glycerin, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Butylene Glycol Dicaprylate/Dicaprate, Niacinamide, CI 77492, Dimethicone, Sodium Chloride, Cyclohexasiloxane, Hydrogenated Polydecene, Bis-Diglyceryl Polyacyladipate-2, Disteardimonium Hectorite, Cetyl PEG/PPG-10/1 Dimethicone, Polyglyceryl-4 Isostearate, Hexyl Laurate, Aluminum Hydroxide, Sorbitan Isostearate, CI 77491, Stearic Acid, Dimethicone/Vinyl Dimethicone Crosspolymer, Portulaca Oleracea Extract, Panthenol, Tocopheryl Acetate, Tribehenin, Beeswax, Acrylates/Dimethicone Copolymer, Hydrogen Dimethicone, Triethoxycaprylylsilane, Triethyl Citrate, Sodium Benzoate, Polymethylsilsesquioxane, Silica, CI 77499, Potassium Sorbate, Fragrance, Prunus Serrulata Flower Extract, Paeonia Officinalis Flower Extract, Polyhydroxystearic Acid, Disodium EDTA, Xylitylglucoside, Adenosine, Alcohol, Anhydroxylitol, Isostearic Acid, Isopropyl Palmitate, Lecithin, Ethylhexyl Palmitate, Polyglyceryl-3 Polyricinoleate, Phenoxyethanol, Zinc Gluconate, Xylitol, Sodium Hyaluronate, 1,2-Hexanediol, Saussurea Involucrata Extract, Narcissus Tazetta Bulb Extract, Ethylhexylglycerin, Glucose, Citrus Aurantifolia (Lime) Flower Extract, Hyaluronic Acid, Chlorphenesin, Milk Protein Extract, Hydrolyzed Hyaluronic Acid

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 your 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

THE SAEM FOUNDATION 02 MEDIUM 
titanium dioxide, zinc oxide, octinoxate, octisalate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70341-601
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide3.84 g  in 30 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.72 g  in 30 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate1.65 g  in 30 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate1.20 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70341-601-021 in 1 CARTON05/01/201811/01/2019
1NDC:70341-601-0130 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(70341-601)

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