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Dr. Jart Water Fuse Beauty Balm

Dosage form: emulsion
Ingredients: titanium dioxide 3.611mg in 50mL, octinoxate 3mg in 50mL, OCTISALATE 2.250mg in 50mL
Labeler: Have and Be Co.,Ltd.
NDC Code: 49404-100

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

Octinoxate 6%

Octisalate 4.5%

Titanium Dioxide 7.222%

Sunscreen

  • Helps prevent sunburn
  • If used as directed with other sun protection meausres (see Directions), decreases the risk of skin cancer and early skin aging casued by the sun

  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

– Limit time in the sun, especially from 10 am - 2 pm

– Wear long-sleeved shirts, pants, hats and sunglasses

  • Children under 6 months: Ask a doctor

For external use only.
Do not use on damaged or broken skin.
When using this product, keep out of eyes. Rinse with water to remove.
Stop using and ask a doctor if rash occurs.

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Water,Cyclopentasiloxane, Phenyl Trimethicone, Alcohol Denat., Dimethicone,
Talc, Dimethicone/Peg-10/15 Crosspolymer, Sodium Chloride, Sodium
Hyaluronate, Cyclohexasiloxane, Cetyl Peg/Ppg-10/1dimethicone, Sodium
Citrate, Triethoxycaprylysilane, Citric Acid, Portulaca Oleracea
Extract, Aloe Glycerin, Butylene Glycol Dicaprylate/Dicaprate,
Polyglyceryl-4 Isosterarate, Disodium Edta, Methylparaben,
Chlorphenesin, Butylparaben, Iron Oxides

Protect the product in this container from excessive heat and direct sunlight

You may report a serious adverse event from use of this product to: Report Reaction, LLC PO Box 22 Plainsboro, NJ 08536-0222

DR. JART WATER FUSE BEAUTY BALM 
titanium dioxide, octinoxate, octisalate emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49404-100
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
titanium dioxide (titanium dioxide) titanium dioxide3.611 mg  in 50 mL
octinoxate (octinoxate) octinoxate3 mg  in 50 mL
OCTISALATE (OCTISALATE) OCTISALATE2.250 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
water 
CYCLOMETHICONE 5 
PHENYL TRIMETHICONE 
alcohol 
talc 
Sodium Chloride 
HYALURONATE SODIUM 
CYCLOMETHICONE 6 
Dimethicone 
Sodium Citrate 
TRIETHOXYCAPRYLYLSILANE 
Citric Acid monohydrate 
Purslane 
ALOE VERA LEAF 
SILICON DIOXIDE 
Hexyl Laurate 
Glycerin 
BUTYLENE GLYCOL 
Polyglyceryl-4 Isostearate 
EDETATE DISODIUM 
Methylparaben 
Chlorphenesin 
Butylparaben 
Iron 
Packaging
#Item CodePackage Description
1NDC:49404-100-021 TUBE in 1 CARTON
1NDC:49404-100-0150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/01/2010
Labeler - Have and Be Co.,Ltd. (690400408)
Registrant - Have and Be Co.,Ltd. (690400408)
Establishment
NameAddressID/FEIOperations
Cosmecca Korea Co., Ltd.688830827manufacture(49404-100)

Revised: 01/2017
 
Have and Be 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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