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ACCOJE SUNSCREEN (SPF50 Broad Spectrum)

Dosage form: cream
Ingredients: ZINC OXIDE 4.97g in 100mL
Labeler: Ucl Co., Ltd.
NDC Code: 70574-0001

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:70574-0001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE4.97 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TITANIUM DIOXIDE 
WATER 
DIMETHICONE 
GLYCERIN 
Packaging
#Item CodePackage Description
1NDC:70574-0001-160 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/04/2016
Labeler - Ucl Co., Ltd. (689847442)
Registrant - Ucl Co., Ltd. (689847442)
Establishment
NameAddressID/FEIOperations
Ucl Co., Ltd.689847442manufacture(70574-0001)

Revised: 04/2016
 
Ucl Co., Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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