FIKIA MARINE ECLIPSE SUN BLOCK SPF 50 PA- titanium dioxide cream

Fikia Marine Eclipse Sun Block SPF 50 PA by

Drug Labeling and Warnings

Fikia Marine Eclipse Sun Block SPF 50 PA by is a Otc medication manufactured, distributed, or labeled by Beauty Line Co., Ltd., Biocostech Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

titanium dioxide

INACTIVE INGREDIENT

water, glycerin, zinc oxide, bentonite, sodium chloride, butylene glycol, disodium edta, fragrance, etc

PURPOSE

protect the skin againse the harmful UV rays

KEEP OUT OF REACH OF CHILDREN

keep out or reach of the children

INDICATIONS & USAGE

apply evenly on exposed areas after daily skin-care routine

WARNINGS

-If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately
-This product is for exeternal use only. Do not use for internal use
-If possible, avoid direct sunlight and store in cool and area of low humidity
-In order to maintain the quality of the product and avoid misuse
-Avoid placing the product near fire and store out in reach of children

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FIKIA MARINE ECLIPSE SUN BLOCK SPF 50 PA 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69327-3001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69327-3001-1	40 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	10/25/2014

Labeler - Beauty Line Co., Ltd. (688528938)

Registrant - Beauty Line Co., Ltd. (688528938)

Establishment
Name	Address	ID/FEI	Business Operations
Biocostech Co., Ltd.		690407325	manufacture(69327-3001)