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

Saemmul O il Control Cushion 02 Natural Beige by

Drug Labeling and Warnings

Saemmul O il Control Cushion 02 Natural Beige 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]

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 containerImage of container

SAEMMUL O IL CONTROL CUSHION 02 NATURAL BEIGE 
titanium dioxide, octinoxate, zinc oxide, octisalate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70341-613
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.03 g  in 12 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.84 g  in 12 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.58 g  in 12 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate0.54 g  in 12 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70341-613-0112 g in 1 CONTAINER; Type 0: Not a Combination Product05/01/201811/01/2019
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(70341-613)

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