Label: ARLLIN GOLDEN COMBINATION CHARISMA CC- titanium dioxide, octinoxate, zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated August 16, 2013

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients: Titanium Dioxide(CI 77891) 9.69%, Ethylhexyl Methoxycinnamate 5%, Zinc Oxide(CI 77947) 2.94%

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Water,Cyclopentasiloxane,Cyclohexasiloxane, Glycerin, Butylene Glycol Dicaprylate/Dicaprate,Phenyl Trimethicone, Niacinamide, Dicaprylyl Carbonate,Methylpropanediol, Cetyl PEG/PPG-10/1 Dimethicone,Pentylene Glyco,Silica, Dimethicone,Sodium Chloride,Sorbitan Isostearate,
    Hexyl Laurate,Disteardimonium Hectorite,Tribehenin, Beeswax,Phenoxyethanol,Iron Oxides (CI 77492), Dimethicone Crosspolymer,Aluminum Hydroxide,Stearic Acid, Triethoxycaprylylsilane,Iron Oxides (CI 77491), Iron Oxides (CI 77499),Fragrance(Parfum),
    Ethylhexylglycerin,Disodium EDTA, Adenosine, Butylene Glycol, Limnanthes Alba (Meadowfoam) Seed Oil,Ascorbyl Glucoside, Tocopheryl Acetate,Hydrolyzed Collagen,Ethylhexyl Palmitate, Glycine Soja (Soybean) Oil, Retinol,Linoleic Acid,Ceramide 3,
    Tocopherol,Portulaca Oleracea Extract,Silica Dimethyl Silylate, Caprylyl Glycol,Sodium Hyaluronate, Hexylene Glycol

  • PURPOSE

    Purpose: UV Protection, Skin Protectant

  • WARNINGS

    Warnings:
    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.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Indications and Usage

    Indications 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 after basic skin care.

  • Dosage and Administration

    Dosage and Administration:
    After basic skin care, gently apply an amount the size of a bean to the entire face using a finger.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    ARLLIN GOLDEN COMBINATION CHARISMA CC 
    titanium dioxide, octinoxate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61315-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide2.90 mg  in 30 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.50 mg  in 30 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.88 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61315-010-0130 mL in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/01/2013
    Labeler - Golden Bridge International (688757866)
    Registrant - Golden Bridge International (688757866)
    Establishment
    NameAddressID/FEIBusiness Operations
    Golden Bridge International688757866manufacture(61315-010)