FDA.reportPublic FDA data

Dr.Jart Premium Beauty Balm Light Medium-Medium

Product NDC
49404-149
11-digit product format
494040149
Labeler code
49404
Product ID
49404-149_47ed1b50-7ba6-110e-e063-6394a90a0559
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
2022-04-25
Substance
TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE; OCTISALATE
Active strength
4.8; 5; 6.8; 4.5 g/100mL; g/100mL; g/100mL; g/100mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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 Light Medium-Medium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE4.8 g/100mL
ZINC OXIDE5 g/100mL
OCTINOXATE6.8 g/100mL
OCTISALATE4.5 g/100mL

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
45b1c2c6-a45b-4a45-bec9-e5341079c0a1Available on FDA.report

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
49404-149-022024-01-30C16284748780-11030e365-6e64-111a-e063-dadaa90a10e249404-149 Dr.Jart+ Premium Beauty Balm Light Medium-Medium
49404-149-022024-01-30C16284748780-11030e365-6e64-111a-e063-dadaa90a10e249404-149 Dr.Jart+ Premium Beauty Balm Light Medium-Medium

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49404-149-02Dr.Jart Premium Beauty Balm Light Medium-Medium1 in 1 CARTONCREAM15
49404-149-02Dr.Jart Premium Beauty Balm Light Medium-Medium40 mL in 1 BOTTLE, PUMPCREAM405

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49404-149DR.JART PREMIUM BEAUTY BALM LIGHT MEDIUM-MEDIUM (ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE) CREAM [HAVE & BE CO., LTD.]4Current NDC, Legacy NDC, 2 package rows20241227_45b1c2c6-a45b-4a45-bec9-e5341079c0a1.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 225 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vertra Ehukai Beige Sunscreen Face Stick Broad Spectrum SPF 38TITANIUM DIOXIDEEai-jr 286, Inc303d5d5a-4c7a-1e23-e063-6294a90a0e582025-03-13WarningsExact identifier
application number: M020
belif Dew guard - daily mineral sunscreen Broad Spectrum SPF 50ZINC OXIDELG H&H CO., LTD.2b4c363b-f767-7901-e063-6394a90adba52025-03-13WarningsExact identifier
application number: M020
Zinc OxideMINERAL SUNSHIELD UNIVERSAL TINT BROAD SPECTRUM SPF 30 SUNSCREENVege Labs LLC303e84e1-3bea-ea6f-e063-6294a90aeaa72025-03-13WarningsExact identifier
application number: M020
MURASAKI BEAUTY Silicence Scar Gel SPF 30ZINC OXIDE, ETHYLHEXYL METHOXYCINNAMATEHaikou Pucao Trading Co.,Ltd303f7dd6-aef2-30ce-e063-6394a90ac00f2025-03-13WarningsExact identifier
application number: M020
SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 110OCTINOXATESHISEIDO AMERICAS CORPORATION393ce1fa-f188-45d0-a23e-2818de9749952025-03-13WarningsExact identifier
application number: M020
SHISEIDO FUTURE solution LX TOTAL PROTECTIVE SAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION1a304bf0-dcda-4887-9738-54ce35ca503b2025-03-13WarningsExact identifier
application number: M020
SHISEIDO REVITALESSENCE SKIN GLOW PRIMERAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION805fd75e-3c53-4ddd-afdc-a65f921822d42025-03-13WarningsExact identifier
application number: M020
Visor Clear Body Oil-Free Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVISOR SKINCARE LLC10abc330-7d45-4049-b80a-dbf58374187e2025-03-12WarningsExact identifier
application number: M020
Visor Clear Face Oil-Free Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVISOR SKINCARE LLC462acd16-b9c0-4f02-b297-d9b54036b5312025-03-12WarningsExact identifier
application number: M020
HAWAIIAN TROPICHOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONEEdgewell Personal Care Brands LLC302982a3-e3f9-ef46-e063-6394a90abaf82025-03-12WarningsExact identifier
application number: M020
Neutrogena Pure And Free Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC41ff1a98-69ff-4d7a-bc89-d986a803cee32025-03-10WarningsExact identifier
application number: M020
Sheer Mineral Antioxidant Sunscreen SPF50ZINC OXIDETopiderm, Inc.1af53e89-debe-4f4c-b0ef-eec2073228df2025-03-07WarningsExact identifier
application number: M020
COOLA Firming Face Serum Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SUNSCREEN SERUMCOOLA LLC85fd7ef4-ed08-4a69-8293-5f3f3d264c042025-03-06WarningsExact identifier
application number: M020
GOLDEN HOUR HYDRATING SPF 30OCTOCRYLENE, OCTISALATE, AND AVOBENZONEDermalogica, LLC.090b5861-20f5-43c6-aff6-d17d61e8568e2025-03-04WarningsExact identifier
application number: M020
Aveeno Baby continuous protection sensitive skin Sunscreen Broad Spectrum SPF50ZINC OXIDEKenvue Brands LLCbbd6710f-a665-437e-b86b-437f732984d12025-03-04WarningsExact identifier
application number: M020
LBEL DIVINE DOUBLE USE LONGWEAR 36H SPF 15 CREME 110OCTINOXATE, ZINC OXIDEBELSTAR S.A.2f8607c5-b5ab-ed81-e063-6394a90a34532025-03-04WarningsExact identifier
application number: M020
ADVANCED PROTECTION SUNSCREEN SPF-30OCTINOXATE, OCTISALATE, ZINC OXIDEBOTANICAL SCIENCE, INC.2f8bbd08-d199-03bd-e063-6294a90adfac2025-03-04WarningsExact identifier
application number: M020
MINERAL TINTED SPF 30TITANIUM DIOXIDE, ZINC OXIDEBOTANICAL SCIENCE, INC.2f9e2252-fb54-363f-e063-6294a90aa7c92025-03-04WarningsExact identifier
application number: M020
LBEL LUMI-AGE ANTI-AGING HYDRATING DAY FACIAL SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBEL STAR S.A.2f717492-347d-5bf8-e063-6294a90a4b5f2025-03-03WarningsExact identifier
application number: M020
CoTZ Kids Mineral Sun StickTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD2f7225d0-ddfa-e19a-e063-6294a90a52a82025-03-03WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49404-149-02494040149021 BOTTLE, PUMP in 1 CARTON (49404-149-02) / 40 mL in 1 BOTTLE, PUMP2022-04-250000-00-00NoNoCurrent