ACCOJE SUNSCREEN (SPF50 BROAD SPECTRUM)- zinc oxide cream

United States - English - NLM (National Library of Medicine)

Buy It Now

Active ingredient:
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
Available from:
Ucl Co., Ltd.
INN (International Name):
ZINC OXIDE
Composition:
ZINC OXIDE 4.97 g in 100 mL
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
for skin protectant apply proper amount to the skin
Authorization status:
OTC monograph final
Authorization number:
70574-0001-1

ACCOJE SUNSCREEN (SPF50 BROAD SPECTRUM)- zinc oxide cream

Ucl 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.

----------

Drug Facts

zinc oxide 4.97%

water, titanium dioxide, dimethicone, glycerin, etc.

for skin protectant

keep out of reach of the children

apply proper amount to the skin

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

for external use only

ACCOJE SUNSCREEN (SPF50 BROAD SPECTRUM)

zinc oxide cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 574-0 0 0 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

ZINC OXIDE

4.9 7 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Ucl Co., Ltd.

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

WATER (UNII: 0 59 QF0 KO0 R)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

GLYCERIN (UNII: PDC6 A3C0 OX)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:70 574-0 0 0 1-1

6 0 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 3/0 1/20 16

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt347

0 2/0 4/20 16

Labeler -

Ucl Co., Ltd. (689847442)

Registrant -

Ucl Co., Ltd. (689847442)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ucl Co ., Ltd.

6 8 9 8 47442

ma nufa c ture (70 574-0 0 0 1)

Revised: 4/2016

Similar products

Search alerts related to this product

Share this information