CAMELLIA MULTIACTION UV SUN SERUM (TITANIUM DIOXIDE, OCTINOXATE) CREAM [AMAROS CO., LTD.]

CAMELLIA MULTIACTION UV SUN SERUM (TITANIUM DIOXIDE, OCTINOXATE) CREAM [AMAROS CO., LTD.]
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NDC 60899-030-01
Set ID a32e1c01-907d-4336-9a98-ec20bfd1334c
Category HUMAN OTC DRUG LABEL
Packager AMAROS CO., LTD.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredients: Titanium Dioxide 4.7%, Ethylhexyl Methoxycinnamate 3.5%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Cyclopentasiloxane/ Cyclohexasiloxane, Butylene Glycol, Isododecane/Disteardimonium Hectorite/ Propylene Carbonate, Caprylic /Capric Triglyceride, Cetyl PEG/PPG-10/ Dimethicone, Isonol Isononanoate, Sorbitol, Dimethicone, Arbutin, Polyglyceryl-4 Isostearate, Sorbitan Sesquioleate, Sodium Chloride, Sodium PCA, Zinc Stearate, Morus Alba Bark Extract, Silica Dimethyl Silytate, Ozokerite, Centella Asiatica Extract, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Juice, Caprylyl Glycol, Caprylhydroxamic Acid, Allantoin, Tocopheryl Acetate, Adenosine, Disodium EDTA, CI 77492, Fragrance.

  • PURPOSE

    Purpose: Sun Screen (UV SPF45/PA++)

  • WARNINGS

    Warnings: 1. In case of having following symptoms after using this product, 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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children: Keep out of reach of babies and children.

  • INDICATIONS AND USAGE

    Indication and Usage: 1. Tighten the lid after using it. 2. Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight. 3. Use it in the morning or evening.

  • DOSAGE AND ADMINISTRATION

    Dosage and Administration: Apply this product on washed face at least 1-3 minutes before going outside. Evenly apply an appropriate amount on face or body, allowing to serum to be absorbed into skin.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    CAMELLIA MULTIACTION UV SUN SERUM 
    titanium dioxide, octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60899-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.88 mg  in 40 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.4 mg  in 40 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60899-030-0140 mL in 1 CARTON; Type 0: Not a Combination Product09/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/01/2013
    Labeler - AMAROS CO., LTD. (690338801)
    Registrant - AMAROS CO., LTD. (690338801)
    Establishment
    NameAddressID/FEIBusiness Operations
    AMAROS CO., LTD.690338801manufacture(60899-030)

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