Saemmul O il Control Cushion 02 Natural Beige by The Saem International Co., Ltd. / Cosmax, Inc.

Drug Details [pdf]

SAEMMUL O IL CONTROL CUSHION 02 NATURAL BEIGE- titanium dioxide, octinoxate, zinc oxide, 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 8.63%, Ethylhexyl Methoxycinnamate 7.00%, Zinc Oxide 4.90%, Ethylhexyl Salicylate 4.50%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Cyclopentasiloxane, Methyl Methacrylate Crosspolymer, Butylene Glycol, Methyl Trimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Silica, Glycerin, Niacinamide, Pentylene Glycol, Caprylyl Methicone, Dimethicone, Butylene Glycol Dicaprylate/Dicaprate, Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl Dimethicone, Iron Oxides (CI 77492), Magnesium Sulfate, Phenoxyethanol, Sorbitan Isostearate, Aluminum Hydroxide, Dimethicone/Vinyl Dimethicone Crosspolymer, Stearic Acid, Iron Oxides (CI 77491), Fragrance(Parfum), Triethoxycaprylylsilane, Disteardimonium Hectorite, Iron Oxides (CI 77499), Ethylhexylglycerin, Adenosine, Disodium EDTA, Calcium Carbonate, Trimethylsiloxysilicate, Betula Platyphylla Japonica Juice, Gossypium Herbaceum (Cotton) Powder, Silica Dimethyl Silylate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, HDI/Trimethylol Hexyllactone Crosspolymer, Dimethicone Crosspolymer, Lecithin, Hydrogenated Castor Oil Isostearate, Glyceryl Caprylate

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 container

SAEMMUL O IL CONTROL CUSHION 02 NATURAL BEIGE
titanium dioxide, octinoxate, zinc oxide, octisalate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70341-613
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.03 g in 12 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.84 g in 12 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.58 g in 12 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	0.54 g in 12 g

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 70341-613-01	12 g in 1 CONTAINER; Type 0: Not a Combination Product	05/01/2018	11/01/2019

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(70341-613)

Revised: 12/2019

Document Id: 7f675277-ba1d-4d1c-8ce0-b0a3008aebcd

Set id: 23677fe8-599f-432e-ab8a-f52c4f599437

Version: 2

Effective Time: 20191230

The Saem International Co., Ltd.