Label: DR FROG INTENSIVE CALMING SUN BLOCK- titanium dioxide, 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 April 13, 2018

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

  • ACTIVE INGREDIENT

    Active ingredients: TITANIUM DIOXIDE 7.30%, ZINC OXIDE 6.99%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    WATER,CYCLOPENTASILOXANE,BUTYLENE GLYCOL,LAMINARIA JAPONICA EXTRACT,CYCLOMETHICONE,ISODODECANE,HYDROGENATED POLY(C6-14 OLEFIN),PEG-10 DIMETHICONE,PHENYL TRIMETHICONE,DIMETHICONE,1,2-HEXANEDIOL,DISTEARDIMONIUM HECTORITE,PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE,ALUMINUM HYDROXIDE,SODIUM CHLORIDE,STEARIC ACID,CYCLOHEXASILOXANE,DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER,BEESWAX,GLYCERYL CAPRYLATE,FRAGRANCE,MYRISTIC ACID,TOCOPHERYL ACETATE,CETYL PEG/PPG-10/1 DIMETHICONE,ULMUS DAVIDIANA ROOT EXTRACT,BIFIDA FERMENT LYSATE,ALLIUM CEPA (ONION) BULB EXTRACT,CENTELLA ASIATICA EXTRACT,PANTHENOL,PROPYLENE GLYCOL,ETHYLHEXYLGLYCERIN,DISODIUM EDTA,GLYCERIN,ALPHA-GLUCAN OLIGOSACCHARIDE,CAPRYLIC/CAPRIC TRIGLYCERIDE,DIPROPYLENE GLYCOL,HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL,HYDROGENATED LECITHIN,ASCORBYL TOCOPHERYL ACETATE,SODIUM GUAIAZULENE SULFONATE,SUCROSE PALMITATE,ALCOHOL,SODIUM HYALURONATE,CRINUM ASIATICUM EXTRACT,POLYSORBATE 80,CERAMIDE NP,NELUMBO NUCIFERA LEAF EXTRACT,CHOLESTEROL,PHYTOSPHINGOSINE

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    Warnings:

    1) Please stop using the product if the following symptoms occur or appear when the skin is exposed to direct sunlight: red blotches, swelling, itchiness or other irritations while using product. Then, consult a dermatologist or a specialist.

    2) Please do not apply the product on wound or any of skin irritation, such as eczema or dermatitis.

    3) Precaution during storage/handling. a) Keep the product closed after using b) Keep out of reach of children c) Avoid storing in high and low temperature and areas exposed to direct sunlight

  • DESCRIPTION

    Uses:

    [UV PROTECTION]

    SPF50+/PA++++

    Sun block with intensified UV defense, calming damaged skin from UV rays and external irritation.

    1. Intensified UVA/UVB defense Intensified UV filter of SPF50+/PA++++ keeps skin healthy by further screening the UV rays.

    2. Cooling formula with less irritation Nature-derived cooling ingredients such as centella asiatica, onion and kelp, calm irritated skin from external stimulation.

    3.Soft clean skin barrier Forms soft and fresh skin barrier, without stickiness, keeping the skin moisty, even from long term outdoor activities of sun exposure.

    Directions:

    Take an appropriate amount and apply to the entire face along with your neck, especially to parts of which can be vulnerable to UV rays at the end of skin care routine or right before the point putting on the make-up.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    DR FROG INTENSIVE CALMING SUN BLOCK 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:22201-1030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.65 g  in 50 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION3.49 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22201-1030-21 in 1 CARTON03/01/2018
    1NDC:22201-1030-150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/01/2018
    Labeler - Charmzone Co Ltd (689049765)
    Registrant - Charmzone Co Ltd (689049765)
    Establishment
    NameAddressID/FEIBusiness Operations
    Charmzone Co., Ltd._Wonju Factory688238394manufacture(22201-1030)