SAEMMUL PERFECT PORE CUSHION 02 NATURAL BEIGE- titanium dioxide, octinoxate, 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 8.89%, Ethylhexyl Methoxycinnamate 6.70%, Ethylhexyl Salicylate 4.00%

INACTIVE INGREDIENT

Inactive ingredients:

Nelumbo Nucifera Flower Water, Cyclopentasiloxane, Glycerin, Diphenylsiloxy Phenyl Trimethicone, PEG-8 Dimethicone, Trimethylsiloxysilicate, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Niacinamide, Pentylene Glycol, Methyl Methacrylate Crosspolymer, PEG-10 Dimethicone, Iron Oxides (CI 77492), Mica (CI 77019), Diphenyl Dimethicone, Acrylates/Stearyl Acrylate/Dimethicone Methacrylate Copolymer, Phenoxyethanol, Dimethicone/Vinyl Dimethicone Crosspolymer, Magnesium Sulfate, Stearic Acid, Alumina, Disteardimonium Hectorite, Iron Oxides (CI 77491), Fragrance(Parfum), Triethoxycaprylylsilane, Aluminum Hydroxide, Iron Oxides (CI 77499), Ethylhexylglycerin, Adenosine, Disodium EDTA, Dimethicone, Water, Dimethicone Crosspolymer, Hydrogenated Castor Oil Isostearate, Polyglutamic Acid

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 PERFECT PORE CUSHION 02 NATURAL BEIGE 
titanium dioxide, octinoxate, octisalate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70341-625
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.06 g  in 12 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate0.80 g  in 12 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate0.48   in 12 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70341-625-0112 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(70341-625)

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