Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30

Product NDC: 46783-002
11-digit product format: 467830002
Labeler code: 46783
Product ID: 46783-002_d1d2fc30-392b-481c-b1ad-b6fe86b3f8a4
Type: HUMAN OTC DRUG
Nonproprietary name: OCTINOXATE and ZINC OXIDE
Dosage form: LOTION
Route: TOPICAL
Labeler: Merz North America, Inc.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-04-01
Substance: OCTINOXATE; ZINC OXIDE
Active strength: 75; 73 mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	46783-002	46783-002-02	D	Discontinued by firm	2026-10-27
excluded package	package	46783-002	46783-002-03	D	Discontinued by firm	2026-10-27
excluded package	package	46783-002	46783-002-05	D	Discontinued by firm	2026-10-27
excluded package	package	46783-002	46783-002-50	D	Discontinued by firm	2026-10-27

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTINOXATE	75 mg/mL
ZINC OXIDE	73 mg/mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
46783-002-01	Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30	1 in 1 CARTON	LOTION	1	8
46783-002-01	Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30	15 mL in 1 BOTTLE	LOTION	15	8
46783-002-02	Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30	1 in 1 CARTON	LOTION	1	8
46783-002-02	Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30	30 mL in 1 BOTTLE	LOTION	30	8
46783-002-03	Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30	200 mL in 1 BOTTLE	LOTION	200	8
46783-002-05	Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30	4 mL in 1 TUBE	LOTION	4	8
46783-002-50	Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30	1 in 1 CARTON	LOTION	1	8
46783-002-50	Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30	50 mL in 1 BOTTLE	LOTION	50	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46783-002	JOURNEE BIO-RESTORATIVE DAY BALM BROAD-SPECTRUM SUNCREEN SPF 30 (OCTINOXATE AND ZINC OXIDE) LOTION [MERZ NORTH AMERICA, INC.]	6	Current NDC, Legacy NDC, 8 package rows	20241109_e120a659-0dfc-42ca-8158-58e8a0b457e5.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 230 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dr.Jart Premium Beauty Balm Light Medium-Medium	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Have & Be Co., Ltd.	02a87c6b-3c7d-5942-e063-6294a90aa452	2025-02-06	Warnings	Exact identifier application number: M020
DR.JART EVERY SUN DAY MINERAL SUN SCREEN	TITANIUM DIOXIDE, ZINC OXIDE	Have & Be Co., Ltd.	02a671ed-485d-d6b7-e063-6394a90ad4af	2025-02-06	Warnings	Exact identifier application number: M020
Dr.Jart Cicapair Tiger Grass Camo Drops	ZINC OXIDE, TITANIUM DIOXIDE	Have & Be Co., Ltd.	01cf0522-a3c1-aea8-e063-6294a90aabfe	2025-02-06	Warnings	Exact identifier application number: M020
DR.JART EVERY SUN DAY SUN FLUID	HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	Have & Be Co., Ltd.	02a72c6d-da42-14b2-e063-6394a90af5cb	2025-02-06	Warnings	Exact identifier application number: M020
EMMA LEWISHAM Sunceutical SPF 50 Mineral Glow Serum	ZINC OXIDE 20%	EMMA LEWISHAM US, INC.	2b097709-913f-d906-e063-6394a90a0446	2025-02-05	Warnings	Exact identifier application number: M020
EMMA LEWISHAM Sunceutical SPF 50 Mineral Face Cream	ZINC OXIDE 20%	EMMA LEWISHAM US, INC.	2c703df8-23af-d630-e063-6294a90a1a24	2025-02-05	Warnings	Exact identifier application number: M020
doTERRA Sun	ZINC OXIDE	doTERRA International, LLC	dd308fef-e312-4ced-e053-2995a90a76fd	2025-02-05	Warnings	Exact identifier application number: M020
OrgaPlus Ultra Pure Sun EX 15g	OCTINOXATE, OCTISALATE, OCTOCRYLENE	BLUEZONWIDE CO.,LTD	b686ef63-7eee-4a4d-a559-417d8b09cc4f	2025-02-05	Warnings	Exact identifier application number: M020
OrgaPlus Ultra Pure Sun EX 22g	OCTINOXATE, OCTISALATE, OCTOCRYLENE	BLUEZONWIDE CO.,LTD	d3c422f6-a83d-48fc-94fc-2749666426c8	2025-02-05	Warnings	Exact identifier application number: M020
EMMA LEWISHAM Sunceutical SPF 50 Mineral Body Cream	ZINC OXIDE 20%	EMMA LEWISHAM US, INC.	2d65b2d0-7013-d0ad-e063-6394a90ad4c2	2025-02-05	Warnings	Exact identifier application number: M020
Olay Sun Hydrating Facial Moisturizer with Sunscreen SPF 30 Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	2d6a6fed-a26e-e3a6-e063-6394a90ae2c7	2025-02-05	Warnings	Exact identifier application number: M020
Brush On Block Sheer Genius SPF 50 Mineral Moisture	ZINC OXIDE	SPF Ventures, LLC	2d4b8c92-b932-89a7-e063-6394a90a621d	2025-02-04	Warnings	Exact identifier application number: M020
Seven Thirty Daily Habit Broad Spectrum SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	SAN DIEGO NATURAL SOAP COMPANY	30ca8f9d-b6a5-4af0-9d7b-487212e40e63	2025-02-03	Warnings	Exact identifier application number: M020
Atlanta Acne Specialist Everyday Sunscreen SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	SAN DIEGO NATURAL SOAP COMPANY	3057f8ad-5850-49a0-b44d-3a1da84126e3	2025-02-03	Warnings	Exact identifier application number: M020
TiZO Ultra Zinc SPF 40 (Tinted)	ZINC OXIDE	Fallien Cosmeceuticals, LTD.	2d3faa43-0d78-58de-e063-6294a90a0b17	2025-02-03	Warnings	Exact identifier application number: M020
TiZO Eye Renewal SPF 20 (Non-Tinted)	ZINC OXIDE	Fallien Cosmeceuticals, LTD	2d40099a-2cfa-1d99-e063-6394a90a36a6	2025-02-03	Warnings	Exact identifier application number: M020
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 ALMOND WD1	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	4ebd7db8-7e6c-46ed-9d0c-6f9f81ea65fe	2025-02-03	Warnings	Exact identifier application number: M020
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 CARAMEL D16	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	e4466bcb-278a-44bb-a87b-479c14037e76	2025-02-03	Warnings	Exact identifier application number: M020
JJAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 BISQUE MDN4	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	282c72a8-bcfa-417f-a79d-9dcf68858833	2025-02-03	Warnings	Exact identifier application number: M020
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 EARTH ND18	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	15eae33b-e8f5-4334-8bf9-fa02ed6ff46d	2025-02-03	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
46783-002-01	46783000201	1 BOTTLE in 1 CARTON (46783-002-01) / 15 mL in 1 BOTTLE	1 bottle	2011-04-01	0000-00-00	No	No	Current
46783-002-02	46783000202	1 BOTTLE in 1 CARTON (46783-002-02) > 30 mL in 1 BOTTLE	1 bottle	2011-04-01	0000-00-00	No	No	Current
46783-002-03	46783000203	200 mL in 1 BOTTLE (46783-002-03)	200 ml	2011-04-01	0000-00-00	No	No	Current
46783-002-05	46783000205	4 mL in 1 TUBE (46783-002-05)	4 ml	2011-04-01	0000-00-00	No	No	Current
46783-002-50	46783000250	1 BOTTLE in 1 CARTON (46783-002-50) > 50 mL in 1 BOTTLE	1 bottle	2019-06-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Journée Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30	Merz North America, Inc.	2026-10-12	HUMAN OTC DRUG LABEL	9