SAEMMUL O IL CONTROL CUSHION 01 LIGHT BEIGE (TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE, OCTISALATE) POWDER [THE SAEM INTERNATIONAL CO., LTD.]

SAEMMUL O IL CONTROL CUSHION 01 LIGHT BEIGE (TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE, OCTISALATE) POWDER [THE SAEM INTERNATIONAL CO., LTD.]
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NDC 70341-612-01
Set ID e295f0bd-8d28-48c6-b805-7f88844fb502
Category HUMAN OTC DRUG LABEL
Packager The Saem International Co., Ltd.
Generic Name
Product Class
Product Number
Application Number PART352
  • 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, Methyl Trimethicone, Butylene Glycol, 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, Magnesium Sulfate, Phenoxyethanol, Iron Oxides (CI 77492), Sorbitan Isostearate, Aluminum Hydroxide, Dimethicone/Vinyl Dimethicone Crosspolymer, Stearic Acid, Iron Oxides (CI 77491), Fragrance(Parfum), Triethoxycaprylylsilane, Disteardimonium Hectorite, Ethylhexylglycerin, Iron Oxides (CI 77499), Adenosine, Disodium EDTA, Calcium Carbonate, Trimethylsiloxysilicate, Betula Platyphylla Japonica Juice, Gossypium Herbaceum (Cotton) Powder, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Silica Dimethyl Silylate, 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

  • INGREDIENTS AND APPEARANCE
    SAEMMUL O IL CONTROL CUSHION 01 LIGHT BEIGE 
    titanium dioxide, octinoxate, zinc oxide, octisalate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70341-612
    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:70341-612-0112 g in 1 CONTAINER; Type 0: Not a Combination Product05/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/01/2018
    Labeler - The Saem International Co., Ltd. (689402402)
    Registrant - The Saem International Co., Ltd. (689402402)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc.689049693manufacture(70341-612)

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