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
Ingredient	Strength
TITANIUM DIOXIDE	48 mg/mL
ZINC OXIDE	50 mg/mL
OCTINOXATE	68 mg/mL
OCTISALATE	45 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
15FIX9V2JP	Internal UNII lookup
SOI2LOH54Z	Internal UNII lookup
4Y5P7MUD51	Internal UNII lookup
4X49Y0596W	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
02a82029-bdb1-cbe0-e063-6294a90a08f3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
d676a241-be05-4740-b3ee-1a5f2ed422d2	Product name	4	20180615
dd8bd48f-20d6-43c7-b471-3ae872868afa	Product name	3	20180125
d41954ff-bc63-4b2c-aba0-9146707659d7	Product name	2	20151117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49404-301-01	Dr.Jart Premium Beauty Balm Fair-Light	1 in 1 CARTON	CREAM	1		3
49404-301-01	Dr.Jart Premium Beauty Balm Fair-Light	40 mL in 1 BOTTLE, PUMP	CREAM	40		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49404-301	DR.JART PREMIUM BEAUTY BALM FAIR-LIGHT (ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE) CREAM [HAVE & BE CO., LTD.]	3	Current NDC, 2 package rows	20250209_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 260 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BIO SPECTRA ATTITUDE	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	06245c8c-93e8-4ebb-bab0-3db64dc178b9	2024-12-09	Warnings	Exact identifier application number: M020
BANANA BOAT KIDS SPF 65 CLEAR SUNSCREEN	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	dc7b0d17-d7c8-433f-e053-2995a90a477d	2024-12-09	Warnings	Exact identifier application number: M020
Sheer Zinc SPF 30	ZINC OXIDE	Allure Labs	b6b45dac-41d0-1b55-e053-2a95a90acf61	2024-12-09	Warnings	Exact identifier application number: M020
Broad Spectrum SPF30 Mineral Sunscreen	ZINC OXIDE	Allure Labs	dafc8e62-7c99-1f6d-e053-2995a90a7791	2024-12-09	Warnings	Exact identifier application number: M020
Prevention Daily Tinted Moisturizer SPF 30	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs	ed883d63-777c-e924-e053-2995a90a162a	2024-12-09	Warnings	Exact identifier application number: M020
I Conceal Flawless Foundation Broad Spectrum SPF 30 Sunscreen Mahogany	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs	dcba05ff-7a68-c5c0-e053-2a95a90a6129	2024-12-09	Warnings	Exact identifier application number: M020
Prevention Daily Matte Moisturizer SPF 30	ZINC OXIDE AND HOMOSALATE	Allure Labs	f0fb1b69-53f2-efff-e053-2995a90af9d4	2024-12-09	Warnings	Exact identifier application number: M020
MD Restoring daily Defense Moisturizer SPF 50	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs Inc	eb8e7109-b5eb-5cc1-e053-2995a90a486f	2024-12-09	Warnings	Exact identifier application number: M020
Prevention Sun Serum SPF 30 Tinted	ZINC OXIDE	Allure Labs	f1761b09-9061-a052-e053-2a95a90a39c8	2024-12-09	Warnings	Exact identifier application number: M020
Prevention Sun Serum SPF30	ZINC OXIDE	Allure Labs	f188669f-7b9f-6e01-e053-2995a90afa3c	2024-12-09	Warnings	Exact identifier application number: M020
Prevention Clear Solar Gel SPF30	AVOBENZON, OCTISALATE AND OCTOCRYLENE	Allure LAbs	f19f6d9b-5249-27a6-e053-2a95a90a8a39	2024-12-09	Warnings	Exact identifier application number: M020
OneSkin OS-01 SHIELD Broad Spectrum SPF 30 Mineral Sunscreen Tinted	ZINC OXIDE	Allure Labs	02e7fb00-2039-c4f8-e063-6294a90a418f	2024-12-09	Warnings	Exact identifier application number: M020
OneSkin OS-01 SHIELD Broad Spectrum SPF 30 Mineral Sunscreen Untinted	ZINC OXIDE	Allure Labs	02f9c859-8d7d-5146-e063-6394a90a57b5	2024-12-09	Warnings	Exact identifier application number: M020
Quench and Protect Hydrating SPF30	ZINC DIOXIDE AND TITANIUM DIOXIDE	Allure Labs.	039e50c1-7b3d-d392-e063-6394a90a4b3c	2024-12-09	Warnings	Exact identifier application number: M020
Tinted Face Cream SPF 15	OCTOCRYLENE, OCTISALATE	Bentley Laboratories, LLC	0d7300ee-adf4-41be-bb9f-257cd2986c0f	2024-12-06	Warnings	Exact identifier application number: M020
Derm Institute Daily Defense Protection Sunscreen Broad Spectrum SPF50	TITANIUM DIOXIDE, ZINC OXIDE	Beautcella Inc.	bad942d8-04da-31d2-e053-2a95a90a9275	2024-12-06	Warnings	Exact identifier application number: M020
TOM FORD ARCHITECTURE RADIANCE HYDRATING FOUNDATION BROAD SPECTRUM SPF 50	ENSULIZOLE, OCTINOXATE, OCTISALATE, AND ZINC OXIDE	TOM FORD BEAUTY DIST	289b824f-bb0b-313e-e063-6394a90ab783	2024-12-06	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Mineral Sunscreen Stick Orange Blossom SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0d840001-a648-df1b-e063-6294a90ab299	2024-12-06	Warnings	Exact identifier application number: M020
Performance Face Sunscreen Broad Spectrum SPF 30	ZINC OXIDE, OCTOCRYLENE, OCTISALATE	Bentley Laboratories, LLC	1629f061-b8fc-4fda-8378-c64e164d41bd	2024-12-06	Warnings	Exact identifier application number: M020
Clear System Brightening Day Cream SPF 15	OCTOCRYLENE, OCTISALATE	Bentley Laboratories, LLC	8cbc8fa4-469f-4fa3-bd8e-27e815989c3f	2024-12-06	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
49404-301-01	49404030101	1 BOTTLE, PUMP in 1 CARTON (49404-301-01) / 40 mL in 1 BOTTLE, PUMP	2023-08-11	2027-11-30	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DR.JART PREMIUM BEAUTY BALM FAIR-LIGHT	Have & Be Co., Ltd. \| Estee Lauder Companies Inc. \| HK Kolmar Canada, Inc	2025-02-06	HUMAN OTC DRUG LABEL	3