FDA.reportPublic FDA data

Dr.Jart Black Label Detox Beauty Balm

Product NDC
49404-139
11-digit product format
494040139
Labeler code
49404
Product ID
49404-139_f05dd396-fb6f-593d-e053-2995a90a4894
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Octinoxate, Octisalate, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Have & Be Co., Ltd.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2018-05-02
Marketing end
0000-00-00
Substance
OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength
2 mg/40mL; mg/40mL; mg/40mL; mg/40mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49404-139DDiscontinued by firm2026-10-05
excluded packagepackage49404-13949404-139-02DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49404-139DR.JART BLACK LABEL DETOX BEAUTY BALM (TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [HAVE & BE CO., LTD.]4Legacy NDC20240621_4e2cb35e-e54a-402d-bb1b-4c3e7f684ddd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49404-139-02494040139021 CONTAINER in 1 CARTON (49404-139-02) > 40 mL in 1 CONTAINER (49404-139-01) 1 container2019-06-180000-00-00NoNoCurrent