SAEMMUL AQUA GLOW CUSHION 02 NATURAL BEIGE (TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE) POWDER [THE SAEM INTERNATIONAL CO., LTD.]

SAEMMUL AQUA GLOW CUSHION 02 NATURAL BEIGE (TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE) POWDER [THE SAEM INTERNATIONAL CO., LTD.]
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NDC 70341-618-01, 70341-618-02
Set ID 18462a1f-a8de-4df5-8832-799cfe463a8c
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 8.89%, Ethylhexyl Methoxycinnamate 6.70%, Ethylhexyl Salicylate 4.00%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Nelumbo Nucifera Flower Water, Cyclopentasiloxane, Glycerin, Diphenylsiloxy Phenyl Trimethicone, Trimethylsiloxysilicate, PEG-8 Dimethicone, Butylene Glycol, Niacinamide, Butylene Glycol Dicaprylate/Dicaprate, 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 carton

  • INGREDIENTS AND APPEARANCE
    SAEMMUL AQUA GLOW CUSHION 02 NATURAL BEIGE 
    titanium dioxide, octinoxate, octisalate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70341-618
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.33 g  in 15 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.00 g  in 15 g
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate0.60 g  in 15 g
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70341-618-021 in 1 CARTON05/01/2018
    1NDC:70341-618-0115 g in 1 CONTAINER; Type 0: Not a Combination Product
    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(70341-618)

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