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

DR FROG INTENSIVE CALMING SUN BLOCK by

Drug Labeling and Warnings

DR FROG INTENSIVE CALMING SUN BLOCK by is a Otc medication manufactured, distributed, or labeled by Charmzone Co Ltd, Charmzone Co., Ltd._Wonju Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

DR FROG INTENSIVE CALMING SUN BLOCK 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 22201-1030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.65 g  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	3.49 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 22201-1030-2	1 in 1 CARTON	03/01/2018
1	NDC: 22201-1030-1	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/01/2018

Labeler - Charmzone Co Ltd (689049765)

Registrant - Charmzone Co Ltd (689049765)

Establishment
Name	Address	ID/FEI	Business Operations
Charmzone Co., Ltd._Wonju Factory		688238394	manufacture(22201-1030)