ECO SOUL Essence Cushion Matt Longwear 23 by The Saem International Co., Ltd. / Cosmax, Inc.

Drug Details [pdf]

ECO SOUL ESSENCE CUSHION MATT LONGWEAR 23- titanium dioxide, zinc oxide, octinoxate 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 11.76%, Ethylhexyl Methoxycinnamate 6.70%, Ethylhexyl Salicylate 4.00%

INACTIVE INGREDIENT

Inactive ingredients:

Rosa Damascena Flower Water, Cyclopentasiloxane, Butylene Glycol, Glycerin, Methyl Methacrylate Crosspolymer, Methyl Trimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Niacinamide, Silica, Synthetic Fluorphlogopite, Dimethicone, 1,2-Hexanediol, Iron Oxides (CI 77492), C12-15 Alkyl Benzoate, Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl Dimethicone, Alcohol Denat., Acrylates/Stearyl Acrylate/Dimethicone Methacrylate Copolymer, Magnesium Sulfate, Disteardimonium Hectorite, Caprylyl Methicone, Sorbitan Isostearate, Dimethicone Crosspolymer, Stearic Acid, Iron Oxides (CI 77491), Alumina, Polyhydroxystearic Acid, Fragrance(Parfum), Triethoxycaprylylsilane, Water, Aluminum Hydroxide, Centella Asiatica Extract, Chamomilla Recutita (Matricaria) Flower Extract, Ethylhexylglycerin, Glyceryl Caprylate, Iron Oxides (CI 77499), Ethylhexyl Palmitate, Isopropyl Myristate, Isostearic Acid, Lecithin, Nelumbo Nucifera Flower Extract, Prunus Mume Fruit Extract, Hydrogenated Castor Oil Isostearate, Adenosine, Polyglyceryl-3 Polyricinoleate, Disodium EDTA, Aloe Ferox Leaf Extract

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:

Apply appropriate amount on a puff and gently apply on the entire face followed by skin texture, tap lightly to finish.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

ECO SOUL ESSENCE CUSHION MATT LONGWEAR 23
titanium dioxide, zinc oxide, octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70341-653
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.76 g in 15 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	1.00 g in 15 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	0.60 g in 15 g

Ingredient Name	Strength
Inactive Ingredients
Butylene Glycol (UNII: 3XUS85K0RA)
Glycerin (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 70341-653-02	1 in 1 CARTON	05/01/2018	11/01/2019
1	NDC: 70341-653-01	15 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(70341-653)

Revised: 12/2019

Document Id: a5f586d4-2eac-4879-8807-06ac5f7397e3

Set id: b08b1347-0eff-4c31-989b-90527ddd6a2f

Version: 2

Effective Time: 20191227