FDA.reportPublic FDA data

Dr.Jart Premium Beauty Balm Fair-Light

Product NDC
49404-301
11-digit product format
494040301
Labeler code
49404
Product ID
49404-301_2d828587-ba06-d5d4-e063-6394a90ab7f5
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide, Titanium Dioxide, Octinoxate, Octisalate
Dosage form
CREAM
Route
TOPICAL
Labeler
Have & Be Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-11
Marketing end
2027-11-30
Substance
TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE; OCTISALATE
Active strength
48; 50; 68; 45 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Dr.Jart Premium Beauty Balm Fair-Light

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE48 mg/mL
ZINC OXIDE50 mg/mL
OCTINOXATE68 mg/mL
OCTISALATE45 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
02a82029-bdb1-cbe0-e063-6294a90a08f3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49404-301-01Dr.Jart Premium Beauty Balm Fair-Light1 in 1 CARTONCREAM13
49404-301-01Dr.Jart Premium Beauty Balm Fair-Light40 mL in 1 BOTTLE, PUMPCREAM403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49404-301DR.JART PREMIUM BEAUTY BALM FAIR-LIGHT (ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE) CREAM [HAVE & BE CO., LTD.]3Current NDC, 2 package rows20250209_02a82029-bdb1-cbe0-e063-6294a90a08f3.zip

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 199 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lipid Shield SPF 30ZINC OXIDEAllure Labs3bce820a-147b-5d8b-e063-6294a90a570d2025-08-07WarningsExact identifier
application number: M020
GR LONGSTAY Matte Face Powder SPF 15OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI62759398-4935-4732-b950-cfbeab82bc5a2025-08-07WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Dry-Touch Sunscreen MAX Broad Spectrum SPF 100 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC3bac8d0a-8726-46c3-e063-6294a90a10752025-08-06WarningsExact identifier
application number: M020
Tanning Club Golden Glow Tanning Oil SPF 15AVOBENZONE, OCTISALATE, OCTOCRYLENETANNING CLUB, LLC33478e28-b079-4e52-9924-845d127be2862025-08-06WarningsExact identifier
application number: M020
Tanning Club Everyday Sunscreen SPF 30HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONETANNING CLUB, LLC805048c4-f2b3-4d35-8674-f44cf3d1a4b52025-08-06WarningsExact identifier
application number: M020
PoolBar I Scream For Sunscreen SPF 50 Coconut and VanillaAVOBENZONE, OCTISALATE, OCTOCRYLENEPOOLBARdeddb91d-b2d5-4d97-bc38-5c11abde9d432025-08-06WarningsExact identifier
application number: M020
PoolBar I Scream For Sunscreen SPF 30 Coconut and VanillaAVOBENZONE, OCTISALATE, OCTOCRYLENEPOOLBAR7f16b91d-29e4-4c21-a008-5dcc858c83d82025-08-06WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 17W MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L053cb3cd-dd16-4d08-b347-a4349fa37c072025-08-06WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 14W Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L7bf90657-b636-41d6-b96c-88d174989f5b2025-08-06WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 15N Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lda7e19cd-6a8b-47df-bfc9-2f0f11b7955c2025-08-06WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 16N Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lf7a1d379-6de0-4be4-84a9-e0ebef332bef2025-08-06WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 18N MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L671be8a6-51b7-45d2-9fff-c7736d2eea3e2025-08-06WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 19W MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L9efa5db5-d774-4089-895c-9667eda0f11b2025-08-06WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 20C MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L76232666-e23f-4842-bd0d-37819739ec3a2025-08-06WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 21W MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L876b9a5d-dae3-47f1-9da6-b5e179fd28cd2025-08-06WarningsExact identifier
application number: M020
Ocean Potion Suncare Mineral 50 Zinc Oxide Continuous SunscreenZINC OXIDEGNL BRANDS INTERNATIONAL, LLC3bba29ab-0e08-b751-e063-6294a90adb7b2025-08-06WarningsExact identifier
application number: M020
UV SOLUTIONS BRIGHTENING TINTED BROAD SPECTRUM SPF 50 SUNSCREEN NIACINAMIDE ANTIOXIDANTSTITANIUM DIOXIDE AND ZINC OXIDECLINIQUE LABORATORIES LLC3bba70e9-da29-f43b-e063-6294a90a08ef2025-08-06WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS PEARL 40mL with Pink Algae SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD0127f290-8c5e-4285-e063-6294a90ae1282025-08-06WarningsExact identifier
application number: M020
GR HD FOUNDATION HIGH DEFINITION SPF 15AVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETIe36550a6-a231-41a8-abda-afdbb2449eaa2025-08-06WarningsExact identifier
application number: M020
GOLDEN ROSE CORRECT AND CONCEAL Concealer Cream PaletteOCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETIcca417c8-b882-48a7-8bd8-ccc6f961a3d22025-08-06WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49404-301-01494040301011 BOTTLE, PUMP in 1 CARTON (49404-301-01) / 40 mL in 1 BOTTLE, PUMP2023-08-112027-11-30NoNoHistorical