FDA.reportPublic FDA data

Dr.Jart Premium Beauty Balm Fair-Light

Manufacturer
Have & Be Co., Ltd. | Estee Lauder Companies Inc. | Kolmar Korea Co., Ltd | Kolmar Korea Co., Ltd.
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
monthly-update
Hydrated at
2026-06-03 17:51:42

Label at a glance#

ProductDr.Jart Premium Beauty Balm Fair-Light
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTISALATE
Label structure8 sections

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OCTINOXATE 6.8%
OCTISALATE 4.5%
TITANIUM DIOXIDE 4.8%
ZINC OXIDE 5.0%


OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

Helps prevent sunburn

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:
■ apply liberally 15 minutes before sun exposure
■ reapply at least every two hours
■ use a water resistant sunscreen if swimming or sweating
■ 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 a.m. – 2 p.m.
– wear long-sleeved shirts, pants, hats and sunglasses
■ children under 6 months of age: ask a doctor

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

When using this product, keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

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, GLYCERIN, TITANIUM DIOXIDE(CI 77891), PEG-10 DIMETHICONE, TALC, C12-15 ALKYL BENZOATE, HEXYL LAURATE, DIPHENYLSILOXY PHENYL TRIMETHICONE, NIACINAMIDE, DIPROPYLENE GLYCOL, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, DIMETHICONE, IRON OXIDES(CI 77492), TRIETHOXYCAPRYLYLSILANE, PHENOXYETHANOL, IRON OXIDES(CI 77491), METHICONE, IRON OXIDES(CI 77499), POLYGLYCERYL-6 POLYRICINOLEATE, TRIHYDROXYSTEARIN, ETHYLHEXYLGLYCERIN, ADENOSINE, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, CITRUS AURANTIFOLIA (LIME) OIL, PINUS SYLVESTRIS LEAF OIL, BHT, EUCALYPTUS GLOBULUS LEAF OIL, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL, CITRUS LIMON (LEMON) PEEL OIL, TOCOPHEROL, ALLANTOIN, 1,2-HEXANEDIOL, PALMITOYL TRIPEPTIDE-5, POLYSORBATE 80, PLATINUM POWDER, PALMITOYL HEXAPEPTIDE-12

STORAGE AND HANDLING SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr. Jart+

BB Premium Beauty Balm

Broad Spectrum SPF40

40ml / 1.35 fl.oz

PDPPDP

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
49404-148-022024-01-30C16284748780-11030e364-fa9f-111a-e063-dadaa90a10e249404-148 Dr.Jart+ Premium Beauty Balm Fair-Light
49404-148-022024-01-30C16284748780-11030e364-fa9f-111a-e063-dadaa90a10e249404-148 Dr.Jart+ Premium Beauty Balm Fair-Light

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49404-148-02Dr.Jart Premium Beauty Balm Fair-Light40 mL in 1 BOTTLE, PUMPCREAM405
49404-148-02Dr.Jart Premium Beauty Balm Fair-Light1 in 1 CARTONCREAM15

Products#

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

DailyMed product names page 1 of 2 · 45 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49404-14849404-148-02

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
LIME OIL, COLD PRESSEDUZH29XGA8GIACT
PINE NEEDLE OIL (PINUS SYLVESTRIS)5EXL5H740YIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
EUCALYPTUS OIL2R04ONI662IACT
BERGAMOT OIL39W1PKE3JIIACT
LEMON OIL, COLD PRESSEDI9GRO824LLIACT
TOCOPHEROLR0ZB2556P8IACT
ALLANTOIN344S277G0ZIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
PALMITOYL TRIPEPTIDE-52A3916MQHOIACT
POLYSORBATE 806OZP39ZG8HIACT
PLATINUM49DFR088MYIACT
PALMITOYL HEXAPEPTIDE-12HO4ZT5S86CIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
CYCLOMETHICONE 50THT5PCI0RIACT
CYCLOMETHICONE 6XHK3U310BAIACT
GLYCERINPDC6A3C0OXIACT
TALC7SEV7J4R1UIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
DIPHENYLSILOXY PHENYL TRIMETHICONEI445L28B12IACT
NIACINAMIDE25X51I8RD4IACT
DIPROPYLENE GLYCOLE107L85C40IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
WATER059QF0KO0RIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)H895X08VNQIACT
DIMETHICONE92RU3N3Y1OIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
PHENOXYETHANOLHIE492ZZ3TIACT
FERRIC OXIDE RED1K09F3G675IACT
METHICONE (20 CST)6777U11MKTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
POLYGLYCERYL-6 POLYRICINOLEATEYPM0ZOC2HRIACT
TRIHYDROXYSTEARIN06YD7896S3IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42024-12-25full-release2026-06-01 00:48:47

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
Dr.Jart Premium Beauty Balm Fair-LightZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.b38b1b64-b433-4e11-9cf6-2108a552d1392025-12-31WarningsExact identifier
ndc (package): 49404-148-02
ndc (product): 49404-148
ndc11 (package): 49404014802
spl id: 47ed1661-a7fb-116b-e063-6394a90aaea4
spl set id: b38b1b64-b433-4e11-9cf6-2108a552d139

Reported adverse events (FAERS/openFDA)#

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