Eco Soul Tone Up CC 02 Natural Tone by The Saem International Co., Ltd. / Cosmax, Inc.

Eco Soul Tone Up CC 02 Natural Tone by

Drug Labeling and Warnings

Eco Soul Tone Up CC 02 Natural Tone by is a Otc medication manufactured, distributed, or labeled by The Saem International Co., Ltd., Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ECO SOUL TONE UP CC 02 NATURAL TONE- octinoxate, titanium dioxide, octisalate 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 6.70%, Titanium Dioxide 4.26%, Ethylhexyl Salicylate 2.50%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Butylene Glycol, Glycerin, Cyclopentasiloxane, Cyclohexasiloxane, Niacinamide, Dicaprylyl Carbonate, Cetyl Ethylhexanoate, Octyldodecanol, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Diphenylsiloxy Phenyl Trimethicone, Triceteareth-4 Phosphate, Glycol Stearate, Phenoxyethanol, Glyceryl Stearate, Potassium Cetyl Phosphate, PEG-2 Stearate, PEG-100 Stearate, Mica (CI 77019), PEG-10 Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Iron Oxides (CI 77492), Silica, Aluminum Hydroxide, Stearic Acid, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Fragrance(Parfum), Iron Oxides (CI 77491), Isohexadecane, Ethylhexylglycerin, Xanthan Gum, Triethoxycaprylylsilane, Polysorbate 80, Iron Oxides (CI 77499), Disodium EDTA, Sorbitan Oleate, Methyl Methacrylate Crosspolymer, Panthenol, Polymethylsilsesquioxane, Xylitylglucoside, Anhydroxylitol, Alcohol, Xylitol, Gentiana Lutea Root Extract, Achillea Millefolium Extract, Artemisia Absinthium Extract, Arnica Montana Flower Extract, Plankton Extract, Spirulina Platensis Extract, Potassium Sorbate

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 02 NATURAL TONE 
octinoxate, titanium dioxide, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70341-669
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate2.34 g  in 35 g
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.49 g  in 35 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate0.87 g  in 35 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70341-669-021 in 1 CARTON05/01/201811/01/2019
1NDC: 70341-669-0135 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(70341-669)

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