FDA.reportPublic FDA data

Dr.Jart Premuim Beauty Balm 03 Deep

Manufacturer
Have & Be Co., Ltd. | Kolmar Korea Co., Ltd.
Effective date
2020-03-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:38:27

Label at a glance#

ProductDr.Jart Premuim Beauty Balm 03 Deep
Active ingredientOCTINOXATE, OCTISALATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 6.79%

Octisalate 4.50%

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INACTIVE INGREDIENT SECTION

WATER
CYCLOPENTASILOXANE
CYCLOHEXASILOXANE
TITANIUM DIOXIDE
ZINC OXIDE
GLYCERIN
TALC
PEG-10 DIMETHICONE
IRON OXIDES
C12-15 ALKYL BENZOATE
NIACINAMIDE
DIPHENYLSILOXY PHENYL TRIMETHICONE
DIPROPYLENE GLYCOL
HEXYL LAURATE
DISTEARDIMONIUM HECTORITE
MAGNESIUM SULFATE
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER
DIMETHICONE
TRIETHOXYCAPRYLYLSILANE
PHENOXYETHANOL
METHICONE
POLYGLYCERYL-6 POLYRICINOLEATE
ETHYLHEXYLGLYCERIN
TRIHYDROXYSTEARIN
CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL
ADENOSINE
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
GLYCERYL POLYMETHACRYLATE
PROPYLENE GLYCOL
1,2-HEXANEDIOL
PLATINUM POWDER
PALMITOYL TRIPEPTIDE-1
POLYSORBATE 80

OTHER SAFETY INFORMATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49404-13649404-136-01, 49404-136-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
CYCLOMETHICONE 6XHK3U310BAIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ZINC OXIDESOI2LOH54ZIACT
GLYCERINPDC6A3C0OXIACT
TALC7SEV7J4R1UIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
FERRIC OXIDE RED1K09F3G675IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
NIACINAMIDE25X51I8RD4IACT
DIPHENYLSILOXY PHENYL TRIMETHICONEI445L28B12IACT
DIPROPYLENE GLYCOLE107L85C40IACT
HEXYL LAURATE4CG9F9W01QIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)H895X08VNQIACT
DIMETHICONE92RU3N3Y1OIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
PHENOXYETHANOLHIE492ZZ3TIACT
METHICONE (20 CST)6777U11MKTIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
TRIHYDROXYSTEARIN06YD7896S3IACT
ORANGE OILAKN3KSD11BIACT
ADENOSINEK72T3FS567IACT
PINE NEEDLE OIL (PINUS SYLVESTRIS)5EXL5H740YIACT
LIME OILUZH29XGA8GIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
EUCALYPTUS OIL2R04ONI662IACT
LEMON OILI9GRO824LLIACT
BERGAMOT OIL39W1PKE3JIIACT
ALLANTOIN344S277G0ZIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
PLATINUM49DFR088MYIACT
PALMITOYL TRIPEPTIDE-1RV743D216MIACT
POLYSORBATE 806OZP39ZG8HIACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a1daa13c-8a88-efb0-e053-2995a90a9fb382f8def2-679b-4b5f-8a24-b610dbbec4a62020-03-27WarningsExact identifier
spl id: a1daa13c-8a88-efb0-e053-2995a90a9fb3
spl set id: 82f8def2-679b-4b5f-8a24-b610dbbec4a6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.