FDA.reportPublic FDA data

Dr.Jart Dis-A-Pore Beauty Balm 01

Manufacturer
Have & Be Co., Ltd. | Estee Lauder Companies Inc. | Kolmar Korea Co., Ltd.
Effective date
2025-01-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:43:25

Label at a glance#

ProductDr.Jart Dis-A-Pore Beauty Balm 01
Active ingredientTITANIUM DIOXIDE, OCTINOXATE, OCTISALATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 15.97%

Octinoxate 4.99%

Octisalate 3.00%

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, DIMETHICONE/VINYL DIMETHICONECROSSPOLYMER, ISODODECANE, LAURYL PEG-10TRIS(TRIMETHYLSILOXY)SILYLETHYLDIMETHICONE, DIMETHICONE, NIACINAMIDE, METHYLPROPANEDIOL, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, IRON OXIDES(CI 77492), SYNTHETIC FLUORPHLOGOPITE, DISTEARDIMONIUM HECTORITE, GLYCERIN, MAGNESIUM SULFATE, ISOPROPYL PALMITATE, HDI/TRIMETHYLOL HEXYLLACTONECROSSPOLYMER, TRIETHOXYCAPRYLYLSILANE, DIPENTAERYTHRITYLHEXAHYDROXYSTEARATE/HEXASTEARATE/HEXAROSINATE, POLYGLYCERYL-4 ISOSTEARATE, ALUMINUM HYDROXIDE, IRON OXIDES(CI 77491), CAPRYLYL GLYCOL, IRON OXIDES(CI 77499), GLYCERYL CAPRYLATE, TRIHYDROXYSTEARIN, ETHYLHEXYLGLYCERIN, PINUS SYLVESTRIS LEAF OIL, CITRUS AURANTIUM BERGAMIA (BERGAMOT)FRUIT OIL, SILICA, ADENOSINE, BHT, TOCOPHEROL, BUTYLENE GLYCOL, ALCOHOL, 1,2-HEXANEDIOL, LECITHIN, PISTACIA LENTISCUS (MASTIC) GUM

OTHER SAFETY INFORMATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49404-145-022024-01-30C16284748780-11030e365-14f7-111a-e063-dadaa90a10e2Dr.Jart Dis-A-Pore Beauty Balm 01

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49404-14549404-145-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
CYCLOMETHICONE 50THT5PCI0RIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)H895X08VNQIACT
ISODODECANEA8289P68Y2IACT
DIMETHICONE92RU3N3Y1OIACT
NIACINAMIDE25X51I8RD4IACT
METHYLPROPANEDIOLN8F53B3R4RIACT
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE75D21FL1PIIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB

Source Document#

Source XML

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
2b235e4a-a9b5-3720-e063-6294a90a8e23affe2e72-e7f1-428d-9e07-d52ef1889fb02025-01-07WarningsExact identifier
spl id: 2b235e4a-a9b5-3720-e063-6294a90a8e23
spl set id: affe2e72-e7f1-428d-9e07-d52ef1889fb0

Reported adverse events (FAERS/openFDA)#

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