FLEXPOWER SUN BLOCK- dimethicone gel 
Powerful X

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.

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Drug Facts

dimethicone


water, butylene glycol, etc.


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


package label
FLEXPOWER SUN BLOCK 
dimethicone gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70042-2001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70042-2001-160 mL in 1 TUBE; Type 0: Not a Combination Product08/28/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/11/2015
Labeler - Powerful X (689515038)
Registrant - Powerful X (689515038)
Establishment
NameAddressID/FEIBusiness Operations
Powerful X689515038manufacture(70042-2001)

Revised: 8/2018
Document Id: 748da96a-4153-ecce-e053-2991aa0aba62
Set id: 140840db-6676-4488-9358-d25fd4d60e1f
Version: 2
Effective Time: 20180829
 
Powerful X