Eco Soul Tone Up CC 01 Vital Tone by The Saem International Co., Ltd. / Cosmax, Inc.

Drug Details [pdf]

ECO SOUL TONE UP CC 01 VITAL 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, Mica (CI 77019), Triceteareth-4 Phosphate, Glycol Stearate, Phenoxyethanol, Glyceryl Stearate, Potassium Cetyl Phosphate, PEG-2 Stearate, PEG-100 Stearate, PEG-10 Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Silica, Aluminum Hydroxide, Stearic Acid, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Fragrance(Parfum), Isohexadecane, Ethylhexylglycerin, Triethoxycaprylylsilane, Xanthan Gum, Iron Oxides (CI 77492), Polysorbate 80, Iron Oxides (CI 77491), Disodium EDTA, Sorbitan Oleate, Ultramarines (CI 77007), Methyl Methacrylate Crosspolymer, Panthenol, Water, 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 carton

ECO SOUL TONE UP CC 01 VITAL TONE
octinoxate, titanium dioxide, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70341-668
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	2.34 g in 35 g
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.49 g in 35 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	0.87 g in 35 g

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 70341-668-02	1 in 1 CARTON	05/01/2018	11/01/2019
1	NDC: 70341-668-01	35 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	05/01/2018	11/01/2019

Labeler - The Saem International Co., Ltd. (689402402)

Registrant - The Saem International Co., Ltd. (689402402)

Name	Address	ID/FEI	Business Operations
Establishment
Cosmax, Inc.		689049693	manufacture(70341-668)

Revised: 12/2019

Document Id: 21f200a3-60cb-4a8a-a7f1-9f15d1bc6814

Set id: a689bea5-f594-4397-b4b1-591b1a31b9c5

Version: 2

Effective Time: 20191228

The Saem International Co., Ltd.