FDA.reportPublic FDA data

Dr.Jart Black Label Detox Beauty Balm

Manufacturer
Have & Be Co., Ltd. | Estee Lauder Companies Inc. | Kolmar Korea Co., Ltd.
Effective date
2025-12-29
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
monthly-update
Hydrated at
2026-06-03 17:46:59

Label at a glance#

ProductDr.Jart Black Label Detox Beauty Balm
Active ingredientTITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE, OCTISALATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 8.32%

Octinoxate 6.00%

Octisalate 2.00%

Zinc Oxide 1.96%

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
PHENYL TRIMETHICONE
METHYLPROPANEDIOL
CAPRYLIC/CAPRIC TRIGLYCERIDE
CYCLOMETHICONE
GLYCERIN
LAURYL PEG-10TRIS(TRIMETHYLSILOXY)SILYLETHYLDIMETHICONE
NIACINAMID

DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE/HEXASTEARATE/HEXAROSINATE
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE
DIMETHICONE/VINYL DIMETHICONECROSSPOLYMER
PENTYLENE GLYCOL
DISTEARDIMONIUM HECTORITE
DIISOSTEARYL MALATE
ISOEICOSANE
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYLDIMETHICONE
SYNTHETIC FLUORPHLOGOPITE
MAGNESIUM SULFATE
IRON OXIDES(CI 77492)
SILICA DIMETHYL SILYLATE
ACRYLATES/DIMETHICONE COPOLYMER
TRIETHOXYCAPRYLYLSILANE
ORYZA SATIVA (RICE) BRAN OIL
VEGETABLE OIL
IRON OXIDES(CI 77491)
IRON OXIDES(CI 77499)
CAPRYLYL GLYCOL
GLYCERYL CAPRYLATE
AMINOPROPYL DIMETHICONE
RHUS SUCCEDANEA FRUIT WAX
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX
ORYZA SATIVA (RICE) BRAN WAX
POLYMETHYLSILSESQUIOXANE
ETHYLHEXYLGLYCERIN
TOCOPHERYL ACETATE
ALUMINA
ALUMINUM HYDROXIDE
SILICA
ADENOSINE
CITRUS AURANTIUM DULCIS (ORANGE) PEELOIL
DIMETHICONE
SODIUM HYALURONATE
PINUS SYLVESTRIS LEAF OIL
CITRUS AURANTIFOLIA (LIME) OIL
EUCALYPTUS GLOBULUS LEAF OIL
TOCOPHEROL
CITRUS LIMON (LEMON) PEEL OIL
CITRUS AURANTIUM BERGAMIA (BERGAMOT)FRUIT OIL
ASCORBYL PALMITATE
BUTYLENE GLYCOL
CAMELLIA SINENSIS LEAF EXTRACT
PORTULACA OLERACEA EXTRACT
CYNARA SCOLYMUS (ARTICHOKE) LEAFEXTRACT
ALOE BARBADENSIS LEAF EXTRACT
1,2-HEXANEDIOL

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49404-139-022024-01-30C16284748780-11030e365-6a44-111a-e063-dadaa90a10e2Dr.Jart Black Label Detox Beauty Balm

Products#

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

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49404-13949404-139-02

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
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
METHYLPROPANEDIOLN8F53B3R4RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CYCLOMETHICONENMQ347994ZIACT
GLYCERINPDC6A3C0OXIACT
NIACINAMIDE25X51I8RD4IACT
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE75D21FL1PIIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)H895X08VNQIACT
PENTYLENE GLYCOL50C1307PZGIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
DIISOSTEARYL MALATEQBS8A3XZGQIACT
ISOEICOSANEAR294KAG3TIACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
RICE BRAN OILLZO6K1506AIACT
CORN OIL8470G57WFMIACT
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
CAPRYLYL GLYCOL00YIU5438UIACT
GLYCERYL MONOCAPRYLATETM2TZD4G4AIACT
SUNFLOWER SEEDR9N3379M4ZIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALUMINUM OXIDELMI26O6933IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ADENOSINEK72T3FS567IACT
ORANGE OILAKN3KSD11BIACT
DIMETHICONE92RU3N3Y1OIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
OCTINOXATE4Y5P7MUD51ACTIB
ZINC OXIDESOI2LOH54ZACTIM
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
471e4989-db5b-094f-e063-6294a90a42c84e2cb35e-e54a-402d-bb1b-4c3e7f684ddd2025-12-29WarningsExact identifier
spl id: 471e4989-db5b-094f-e063-6294a90a42c8
spl set id: 4e2cb35e-e54a-402d-bb1b-4c3e7f684ddd

Reported adverse events (FAERS/openFDA)#

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