Dr. Jart Water Fuse Beauty Balm

Dosage form: cream
Ingredients: titanium dioxide 3.611mL in 50mL, octinoxate 3mL in 50mL, OCTISALATE 2.250mL 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

Active Ingredient

Titanium Dioxide 7.222%

Octinoxate 6%

Octisalate 4.5%

Warnings
for external use only

Stop use and ask a doctor if

  •     rash or irritation develops and lasts

When using this product

  •     keep out of eyes. Rinse with water to remove

Keep out of reach of children

  •     If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Sunscreen

Enter section text here

Inactive ingredient
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

DR. JART WATER FUSE BEAUTY BALM 
titanium dioxide, octinoxate, octisalate cream
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 mL  in 50 mL
octinoxate (octinoxate) octinoxate3 mL  in 50 mL
OCTISALATE (OCTISALATE) OCTISALATE2.250 mL  in 50 mL
Inactive Ingredients
Ingredient NameStrength
water 
CYCLOMETHICONE 5 
PHENYL TRIMETHICONE 
alcohol 
dimethicone 
talc 
Sodium Chloride 
HYALURONATE SODIUM 
CYCLOMETHICONE 6 
Dimethicone 
Sodium Citrate 
OCTYLTRIETHOXYSILANE 
Citric Acid monohydrate 
Purslane 
ALOE VERA LEAF 
SILICON DIOXIDE 
Hexyl Laurate 
Butylene Glycol 
Glycerin 
BUTYLENE GLYCOL 
Polyglyceryl-4 Isostearate 
EDETATE DISODIUM 
Methylparaben 
Chlorphenesin 
Butylparaben 
Iron 
Packaging
#Item CodePackage Description
1NDC:49404-100-021 TUBE (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 - Kodent Inc. (172903218)
Establishment
NameAddressID/FEIOperations
Have and Be Co.,Ltd.690400408manufacture

Revised: 10/2010
 
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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