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 185 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ELROEL Pang Pang Sun Cushion PlusZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEMONOGLOT HOLDINGS Inc.5ffaad65-f0b2-416a-b0a3-b92e880641e42025-09-18WarningsExact identifier
application number: M020
e.l.f. Camo CC Cream SPF 30 Fair 125 CHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEe.l.f. Cosmetics, Inc.407f9c0d-31c6-f5bb-e063-6394a90a4db42025-09-18WarningsExact identifier
application number: M020
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC1630feee-7e0d-c6f4-e063-6294a90a7b1c2025-09-17WarningsExact identifier
application number: M020
Guise Tinted DropsZINC OXIDEDonis Men LLC3f039049-5004-2888-e063-6294a90a51502025-09-17WarningsExact identifier
application number: M020
ONE SIZE ON TIL DAWNONE SIZE ON TIL DAWNPogi Beauty LLC3f05d90b-9274-4d21-e063-6294a90a84852025-09-17WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint DP3ZINC OXIDEPUR Minerals3f073413-b314-e5da-e063-6394a90a9ab42025-09-17WarningsExact identifier
application number: M020
e.l.f. Hydrating Camo CC Cream SPF30 Fair 100 WHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEe.l.f. Cosmetics, Inc.3fa7ef54-2c4d-9883-e063-6294a90a8d882025-09-17WarningsExact identifier
application number: M020
CVS SPF 50 Face SunscreenTITANIUM DIOXIDE, ZINC OXIDECVS26a69a47-947a-a478-e063-6394a90aa4682025-09-16WarningsExact identifier
application number: M020
SkinSuit TM 3 in 1 Moisturizer SPF 50ZINC OXIDESkin Authority LLC5eb27be9-9e80-4f4a-b193-b918d831555d2025-09-15WarningsExact identifier
application number: M020
Sun and Honey Tallow Sunscreen SPF 30ZINC OXIDEAmara Ventures3eda8a70-7c9e-e920-e063-6394a90a85a22025-09-15WarningsExact identifier
application number: M020
Klein Tools Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKLEIN TOOLS, INC.3edcc26a-d960-3fa8-e063-6394a90ab7032025-09-15WarningsExact identifier
application number: M020
Klein Tools Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENEKLEIN TOOLS, INC.3ede5e54-4c9f-02f7-e063-6294a90a9df62025-09-15WarningsExact identifier
application number: M020
I.C. Industrial SunscreenZINC OXIDE, OCTINOXATE, OXYBENZONE, AND OCTISALATER & R Lotion, Incb89d687a-7b36-4643-9817-765d4710ca602025-09-15WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC97795f0e-d867-4e17-b7c9-ede08e7df70c2025-09-12WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 36N DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.2d05659c-57d2-4faf-ab67-1b8d68945aed2025-09-12WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 37W DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.5ff2b9e4-a778-4667-8c3c-3561317b374a2025-09-12WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 39N DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.bc4f909f-3e2c-4fd7-a129-3c2fac8259f02025-09-12WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 40C DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.2dd9a30a-2cde-44c0-9350-3aeab9f7091b2025-09-12WarningsExact identifier
application number: M020
Dolce and Gabbana Get Your Healthy Glowy Skin Bergamot Glow Primer Blueberry Nutri TintZINC OXIDEDolce & Gabbana Beauty S.R.Le375412e-8685-49a2-b1b0-00ab114e14b72025-09-12WarningsExact identifier
application number: M020
Beach Club Mineral SunscreenZINC OXIDE, OCTINOXATE, OXYBENZONE, AND OCTISALATER & R Lotion, Incd9aae241-229e-4123-abe9-99f74f5ab0b32025-09-12WarningsExact 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