ACCOJE SUNSCREEN (SPF50 BROAD SPECTRUM)- zinc oxide cream

ACCOJE SUNSCREEN (SPF50 Broad Spectrum) by

Drug Labeling and Warnings

ACCOJE SUNSCREEN (SPF50 Broad Spectrum) by is a Otc medication manufactured, distributed, or labeled by Ucl Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

zinc oxide 4.97%

INACTIVE INGREDIENT

water, titanium dioxide, dimethicone, glycerin, etc.

PURPOSE

for skin protectant

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

apply proper amount to the skin

WARNINGS

1. Do not use in the following cases(Eczema and scalp wounds)
2.Side Effects
1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor
3.General Precautions
1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately
2)This product is for exeternal use only. Do not use for internal use
4.Storage and handling precautions
1)If possible, avoid direct sunlight and store in cool and area of low humidity
2)In order to maintain the quality of the product and avoid misuse
3)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

ACCOJE SUNSCREEN (SPF50 BROAD SPECTRUM) 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70574-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.97 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70574-0001-1	60 mL in 1 TUBE; Type 0: Not a Combination Product	03/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/04/2016

Labeler - Ucl Co., Ltd. (689847442)

Registrant - Ucl Co., Ltd. (689847442)

Establishment
Name	Address	ID/FEI	Business Operations
Ucl Co., Ltd.		689847442	manufacture(70574-0001)