QT SUN BLOCK - octinoxate, titanium dioxide, enzacamene cream 
Cleansia 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.

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Active Ingredients:
Ethylhexyl Methoxycinnamate, Titanium Dioxide, 4-Methylbenzylidene Camphor, Methylene Bis-Benzotriazolyl Tetramethylbutylphenol, Benzophenone-3

Inactive Ingredients:
Water, Cyclopentasiloxane, Disteardimonium Hectorite, Dimethiconol, Tocopheryl Acetate, PEG-10 Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Sorbitan Sesquioleate, Glyceryl Behenate/Eicosadioate, Cetyl Ethylhexanoate, Cyclohexasiloxane, Propylene Glycol, Dipropylene Glycol, Allantoin, Aluminum Hydroxide, Stearic Acid, Xanthan Gum, Methylparaben, Sodium Chloride, Butylparaben, Imidazolidinyl Urea, Fragrance, Ethylparaben, Oryza Sativa (Rice) bran Oil, Oryza Sativa (Rice) Bran Extract

Directions:
When you use or do leisure, apply reasonable amount on your body exposed to UV including face, neck, arms and legs at your finishing step of basic makeup.  Take more frequent reapplication for long time outdoor activities

Notice for Use:
1. Discontinue if the following symptom appears and consult with dermatologist for the continuous problem of use
a) Discontinue use if redness, rash, irritation or tingling appears
b) Discontinue if the above symptom appears by a direct sunlight on the applied part
2. Avoid the part for a cut, eczema or dermatitis

Keep this and all drugs out of reach of children

Caution:
- Be careful it may be slippery when contact with the product
- Be careful not to make contact with clothes
- Be careful not to give a shock since the container may be broken and get injured

Storage and Handling:
- To keep the freshness, please close the lid after the use
- Do not store this product in a place of high or low temperature
- Do not expose it to the direct sunlight

BOX LABEL
QT SUN BLOCK 
octinoxate, titanium dioxide, enzacamene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45167-516
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.2 g  in 100 g
ENZACAMENE (UNII: 8I3XWY40L9) (ENZACAMENE - UNII:8I3XWY40L9) ENZACAMENE2.0 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45167-516-16100 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/21/2010
Labeler - Cleansia Co Ltd (687655956)
Registrant - Cleansia Co Ltd (687655956)
Establishment
NameAddressID/FEIBusiness Operations
Cleansia Co Ltd687655956manufacture

Revised: 1/2010
Document Id: b5ab35c8-9590-4ff4-9c71-3d19867ec713
Set id: 80e07a95-6249-49b2-8610-c430b9fcd5b4
Version: 1
Effective Time: 20100121
 
Cleansia Co Ltd