RUBY-CELL 4U PLUS SUN- titanium dioxide cream 
Aphrozone Co., Ltd

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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titanium dioxide

water, glyceryl stearate, glycerin, etc

sun protect

1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).
1) Occurrence of red spots, swelling, itchiness, and other irritation
2) If the symptoms above occur after the application area is exposed to direct sunlight

2. Do not use on open wounds, eczema, and other irritations
3. Precaution for Storage and Handling
1) Close the lid after use
2) Keep out of reach of infants and children
3) Do not to store in a place with high/low temperature and exposed to direct sunlight

4. Use as avoiding eye areas.

Keep out of reach of children.

apply proper amount to the skin

external use only

label

RUBY-CELL 4U PLUS SUN 
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72321-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ADENOSINE (UNII: K72T3FS567)  
NIACINAMIDE (UNII: 25X51I8RD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72321-0001-160 g in 1 TUBE; Type 0: Not a Combination Product05/22/201806/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/22/201806/01/2018
Labeler - Aphrozone Co., Ltd (688897046)
Registrant - Aphrozone Co., Ltd (688897046)
Establishment
NameAddressID/FEIBusiness Operations
Aphrozone Co., Ltd.688897046label(72321-0001)
Establishment
NameAddressID/FEIBusiness Operations
COSON Co., Ltd._Osan Plant689847210manufacture(72321-0001)

Revised: 6/2018
 
Aphrozone Co., Ltd