DR FROG INTENSIVE CALMING SUN BLOCK- titanium dioxide, zinc oxide cream 
Charmzone Co Ltd

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.

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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

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)

Revised: 4/2018
Document Id: 720a3a65-d009-49d8-a809-dcd17000ff38
Set id: 50b1e9e6-8089-4bb8-afd6-038f54ee54d7
Version: 1
Effective Time: 20180413
 
Charmzone Co Ltd