DR.JART PREMIUM BEAUTY BALM 02 MEDIUM DEEP- octinoxate, octisalate cream 
Have & Be 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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Dr.Jart Premium Beauty Balm 02 Medium deep

Titanium Dioxide 7.96%

Octinoxate 6.79%

Zinc Oxide 5.00%

Octisalate 4.50%

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

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

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

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
CYCLOHEXASILOXANE
GLYCERIN
PEG-10 DIMETHICONE
NIACINAMIDE
C12-15 ALKYL BENZOATE
DIPHENYLSILOXY PHENYL TRIMETHICONE
DIPROPYLENE GLYCOL
HEXYL LAURATE
IRON OXIDES(CI 77492)
TALC
DISTEARDIMONIUM HECTORITE
MAGNESIUM SULFATE
DIMETHICONE/VINYL DIMETHICONECROSSPOLYMER
DIMETHICONE
TRIETHOXYCAPRYLYLSILANE
IRON OXIDES(CI 77491)
PHENOXYETHANOL
IRON OXIDES(CI 77499)
METHICONE
POLYGLYCERYL-6 POLYRICINOLEATE
ETHYLHEXYLGLYCERIN
TRIHYDROXYSTEARIN
ADENOSINE
CITRUS AURANTIUM DULCIS (ORANGE) PEELOIL
PINUS SYLVESTRIS LEAF OIL
CITRUS AURANTIFOLIA (LIME) OIL
BHT
EUCALYPTUS GLOBULUS LEAF OIL
CITRUS LIMON (LEMON) PEEL OIL
CITRUS AURANTIUM BERGAMIA (BERGAMOT)FRUIT OIL
ALLANTOIN
1,2-HEXANEDIOL
PALMITOYL TRIPEPTIDE-5
PLATINUM POWDER
PALMITOYL HEXAPEPTIDE-12
POLYSORBATE 80

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

image description

DR.JART PREMIUM BEAUTY BALM 02 MEDIUM DEEP 
octinoxate, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49404-138
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.716 mg  in 40 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2 mg  in 40 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.8 mg  in 40 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.18 mg  in 40 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
GLYCERIN (UNII: PDC6A3C0OX)  
TALC (UNII: 7SEV7J4R1U)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
NIACINAMIDE (UNII: 25X51I8RD4)  
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
ORANGE OIL (UNII: AKN3KSD11B)  
ADENOSINE (UNII: K72T3FS567)  
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)  
LIME OIL (UNII: UZH29XGA8G)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
LEMON OIL (UNII: I9GRO824LL)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ALLANTOIN (UNII: 344S277G0Z)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
PLATINUM (UNII: 49DFR088MY)  
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49404-138-021 in 1 CARTON07/20/2020
1NDC:49404-138-0140 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/08/2018
Labeler - Have & Be Co., Ltd. (690400408)
Registrant - Have & Be Co., Ltd. (690400408)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co., Ltd.689512611manufacture(49404-138)

Revised: 12/2022
Document Id: f05d3d17-6ee9-464b-e053-2995a90aaa76
Set id: 7afc2570-030e-4749-9297-9501d9a1c707
Version: 4
Effective Time: 20221221
 
Have & Be Co., Ltd.