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 64 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLC232ab407-1903-45d8-a2b2-6992ffd30d002026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLC0ccef180-0eb1-cf2b-e063-6394a90adf0c2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen for Kids SPF 50AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLC6a455f1a-4285-44c3-820a-85a50d1bbc5b2026-02-06WarningsExact identifier
application number: M020
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLC15bf22f5-a8f5-44bb-b787-2b762b330d612026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLC6d1ad14e-afc6-4676-87d7-3e50e3a02fe92026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen for Babies SPF 50AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLC64766ed9-bd47-498d-bf59-fb30a7bf7e892026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Broad Spectrum Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLCccb651f6-e567-4c5f-9109-8767270cc4be2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
SunscreenAVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLC80dcd255-3a6c-4b79-b081-519c9dac990a2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Moisturizing Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Service, LLC9de8b6b1-024b-4b71-96e6-fea68088d3ab2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
SunscreenSUNSCREENRetail Business Services, LLC96221c10-ebfe-4385-b6b5-d504258df36c2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Moisturizing Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLCe2adbde9-3c8b-45f3-b4ef-4936b88d812d2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
NUDESCREEN DEWY ILLUMINATING GLOW SPF 30 - Sunkissed GlowZINC OXIDE SUNSCREENBentley Laboratories, LLCbf1a237b-b27e-4c55-8ded-e348240a5b9a2026-02-06WarningsExact identifier
application number: M020
SEYTU Body SunscreenTITANIUM DIOXIDE AND ZINC OXIDEOmnilife USA, Inc.c411e9a6-b2ea-446b-a886-b92c61736e6c2026-02-05WarningsExact identifier
application number: M020
SEYTU Facial SunscreenTITANIUM DIOXIDE AND ZINC OXIDEOmnilife USA, Inc.96fd37fb-c3ff-413f-b2c8-50754f320ecc2026-02-05WarningsExact identifier
application number: M020
Sun Veil IlluminatingElixir Face Sunscreen SPF 38OCTISALATE, OCTOCRYLENE, ZINC OXIDEKoco Life LLC4a15c479-d676-9e52-e063-6394a90a4eb42026-02-05WarningsExact identifier
application number: M020
Golden Sunglaze Sheer Body Mist Sunscreen SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKoco Life LLC22d0a5db-6af1-a3ca-e063-6394a90a68ef2026-02-05WarningsExact identifier
application number: M020
Sunglaze Sheer Setting Mist Sunscreen SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTYOCRYLENEKoco Life LLC22ce9b26-2bf8-c1ea-e063-6394a90a8ec22026-02-05WarningsExact identifier
application number: M020
Peppermint SPF 15 Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENENaples Soap Company, Inc.24adffd4-5177-f5d5-e063-6294a90a78502026-02-05WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 BambooOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASebfe03e7-614f-44b1-b1f1-78edc7e274cc2026-02-05WarningsExact identifier
application number: M020
Serious Skincare Serious-C3 Plasma Bio Technology C Cream SPF 30AVOBENZONE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONEFlageoli Limited66f29201-6cbe-46d0-b54c-005a1ecefac42026-02-04WarningsExact 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