Label: DR FROG INTENSIVE CALMING SUN BLOCK- titanium dioxide, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 22201-1030-1, 22201-1030-2 - Packager: Charmzone Co Ltd
- 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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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
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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
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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
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INGREDIENTS AND APPEARANCE
DR FROG INTENSIVE CALMING SUN BLOCK
titanium dioxide, zinc oxide creamProduct 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)