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Dr.Jart V7 Beauty Balm

Dosage form: cream
Ingredients: TITANIUM DIOXIDE 4.176mL in 40mL, ZINC OXIDE 0.576mL in 40mL
Labeler: Have and Be Co., Ltd.
NDC Code: 49404-105

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.

Human OTC Drug Label

Active Ingredients

Titanium Dioxide 10.44% Zinc Oxide 1.44%

Warnings Section

For External Use Only

Ask Doctor Section

Stop use and ask a doctor if rash or irritation develops and lasts.

Keep out of Reach of Children

if swallowed get medical help or contact a poison control center right away.

Purpose

Sunscreen

Instructions for Use

-Apply Generously and as needed.

- Children under 6 months of age: Ask a doctor

- Reapply as needed or after towel drying, swimming, and sweating.

Inactive Ingredients

Water
CYCLOMETHICONE 5
BUTYLENE GLYCOL
DICAPRYLATE/DICAPRATE
Dimethicone
Cyclohexasiloxane
POLYMETHYLSILSESQUIOXANE
(11 MICRONS)
Glycerin
Phenyl
Trimethicone
PEG-10 DIMETHICONE (600 CST)
Magnesium Sulfate
DISTEARYLDIMONIUM
FERRIC OXIDE YELLOW
Talc
Calcium
Stearate
CAPRYLYL GLYCOL
Propylene Carbonate
Ethylhexylglycerin
CETYL PEG/PPG-10/1
DIMETHICONE (HLB 5)
Polyglyceryl-4 Isostearate
Phenoxyethanol
Hexyl Laurate
Triethoxycaprylylsilane
Sodium
Ascorbyl Phosphate
Niacinamide
Butylene
Glycol
Panthenol
Hydrogen
Dimethicone
.ALPHA.-TOCOPHEROL ACETATE
1,2-Hexanediol
EDETATE DISODIUM
Alcohol
RUMEX CRISPUS ROOT
MYRCIARIA DUBIA FRUIT
HIPPOPHAE RHAMNOIDES FRUIT
PANTOLACTONE, (R)-
HYALURONATE SODIUM

Package Label

DR.JART V7 BEAUTY BALM 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49404-105
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE4.176 mL  in 40 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE0.576 mL  in 40 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 56.996 mL  in 40 mL
DIMETHICONE2.86 mL  in 40 mL
CYCLOMETHICONE 62.8 mL  in 40 mL
POLYMETHYLSILSESQUIOXANE (11 MICRONS)2 mL  in 40 mL
GLYCERIN0.804 mL  in 40 mL
PHENYL TRIMETHICONE0.8 mL  in 40 mL
PEG-10 DIMETHICONE (600 CST)0.8 mL  in 40 mL
MAGNESIUM SULFATE0.6 mL  in 40 mL
DISTEARYLDIMONIUM0.488 mL  in 40 mL
FERRIC OXIDE YELLOW0.411 mL  in 40 mL
TALC0.394 mL  in 40 mL
CALCIUM STEARATE0.36 mL  in 40 mL
CAPRYLYL GLYCOL0.14 mL  in 40 mL
PROPYLENE CARBONATE0.08 mL  in 40 mL
Ethylhexylglycerin0.08 mL  in 40 mL
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)0.076 mL  in 40 mL
POLYGLYCERYL-4 ISOSTEARATE0.068 mL  in 40 mL
PHENOXYETHANOL0.0603 mL  in 40 mL
HEXYL LAURATE0.056 mL  in 40 mL
TRIETHOXYCAPRYLYLSILANE0.0427 mL  in 40 mL
SODIUM ASCORBYL PHOSPHATE0.04 mL  in 40 mL
NIACINAMIDE0.04 mL  in 40 mL
BUTYLENE GLYCOL0.0382 mL  in 40 mL
PANTHENOL0.024 mL  in 40 mL
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE0.02 mL  in 40 mL
.ALPHA.-TOCOPHEROL ACETATE0.02 mL  in 40 mL
1,2-HEXANEDIOL0.02 mL  in 40 mL
EDETATE DISODIUM0.012 mL  in 40 mL
ALCOHOL0.0012 mL  in 40 mL
RUMEX CRISPUS ROOT0.0006 mL  in 40 mL
MYRCIARIA DUBIA FRUIT0.0006 mL  in 40 mL
HIPPOPHAE RHAMNOIDES FRUIT0.0006 mL  in 40 mL
PANTOLACTONE, (R)-0.0004 mL  in 40 mL
HYALURONATE SODIUM0.0002 mL  in 40 mL
WATER15.1142 mL  in 40 mL
Packaging
#Item CodePackage Description
1NDC:49404-105-021 TUBE in 1 CARTON
1NDC:49404-105-0140 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/30/2012
Labeler - Have and Be Co., Ltd. (690400408)
Registrant - Have and Be Co., Ltd. (690400408)
Establishment
NameAddressID/FEIOperations
Have and Be Co., Ltd.690400408manufacture(49404-105)

Revised: 07/2012
Document Id: fb5a1a53-0c1d-428f-93e7-4eea5aa531a3
Set id: 29147b25-61a0-4e2c-8a32-8138fa4146e7
Version: 5
Effective Time: 20120730
 
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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