ECO SOUL TONE UP CC 03 CLEAR BRIGHT- octinoxate, titanium dioxide, octisalate, 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: Ethylhexyl Methoxycinnamate 6.00%, Titanium Dioxide 4.02%, Ethylhexyl Salicylate 2.00%, Zinc Oxide 1.91%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Cyclopentasiloxane, Dipropylene Glycol, Glycerin, Isopropyl Isostearate, PEG-10 Dimethicone, Niacinamide, Caprylyl Methicone, Talc, Disteardimonium Hectorite, Magnesium Sulfate, Dimethicone/Vinyl Dimethicone Crosspolymer, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, C12-14 Pareth-3, Dimethicone, Phenoxyethanol, Aluminum Hydroxide, Aluminum Stearate, Fragrance, Methicone, Iron Oxides(CI 77492), Ethylhexylglycerin, Portulaca Oleracea Extract, Tocopheryl Acetate, Trihydroxystearin, Iron Oxides(CI 77491), Adenosine, Butylene Glycol, Aminopropyl Dimethicone, Polymethylsilsesquioxane, Biosaccharide Gum-1, Triethoxycaprylylsilane, Sodium Hyaluronate, Aloe Barbadensis Leaf Extract, Xylitylglucoside, Anhydroxylitol, Xylitol

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

ECO SOUL TONE UP CC 03 CLEAR BRIGHT 
octinoxate, titanium dioxide, octisalate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70341-670
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate2.10 g  in 35 g
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.40 g  in 35 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate0.70 g  in 35 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.66 g  in 35 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Dipropylene Glycol (UNII: E107L85C40)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70341-670-021 in 1 CARTON05/01/201811/01/2019
1NDC:70341-670-0135 g 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
Cosmax, Inc.689049693manufacture(70341-670)

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