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	2026-11-13
excluded package	package	46783-002	46783-002-03	D	Discontinued by firm	2026-11-13
excluded package	package	46783-002	46783-002-05	D	Discontinued by firm	2026-11-13
excluded package	package	46783-002	46783-002-50	D	Discontinued by firm	2026-11-13

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4Y5P7MUD51	Internal UNII lookup
SOI2LOH54Z	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
e120a659-0dfc-42ca-8158-58e8a0b457e5	Available on FDA.report

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 277 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Equaline Sport Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	United Natural Foods, Inc. dba UNFI	f0dda684-b0ed-629c-e053-2995a90a1287	2024-10-16	Warnings	Exact identifier application number: M020
EQUALINE SPORT SUNSCREEN CONTINUOUS SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	United Natural Foods, Inc. dba UNFI	e46d20b3-2897-1370-e053-2a95a90a619c	2024-10-16	Warnings	Exact identifier application number: M020
MEIJER BROAD SPECTRUM SPF 30 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISLATE, OCTOCRYLENE	MEIJER DISTRIBUTION. INC.	a71d34d4-a924-6421-e053-2995a90a647e	2024-10-16	Warnings	Exact identifier application number: M020
MEIJER BROAD SPECTRUM SPF 50 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	MEIJER DISTRIBUTION, INC.	a71bf24f-b923-b81f-e053-2995a90a0072	2024-10-16	Warnings	Exact identifier application number: M020
MEIJER KIDS BROAD SPECTRUM SPF 50 MINERAL BASED SUNSCREEN	OCTINOXATE, OCTISALATE, ZINC OXIDE	MEIJER DISTRIBUTION INC	a9f4fd45-3bbb-14a7-e053-2995a90ab28f	2024-10-16	Warnings	Exact identifier application number: M020
WEGMANS SPORT CLEAR CONTINUOUS SUNSCREEN SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WEGMANS FOOD MARKETS INC	e4b7df52-2bc9-1afc-e053-2a95a90a4f87	2024-10-16	Warnings	Exact identifier application number: M020
Wegmans SPORT BROAD SPECTRUM SPF 30 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WEGMANS FOOD MARKETS INC	f12bff9a-bd3c-e35d-e053-2995a90abf17	2024-10-16	Warnings	Exact identifier application number: M020
MINERAL SUNSCREEN SPF 50	ZINC OXIDE, TITANIUM DIOXIDE	WEGMANS FOOD MARKETS INC	bfe24f55-d0e5-254a-e053-2995a90a2fd3	2024-10-16	Warnings	Exact identifier application number: M020
Wegmans Sport Broad Spectrum SPF 70 Clear Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENE	WEGMANS FOOD MARKETS INC	e7175821-e514-1bea-e053-2995a90a0c0d	2024-10-16	Warnings	Exact identifier application number: M020
Wegmans Kids and Sport Broad Spectrum SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WEGMANS FOOD MARKETS INC	f3463f81-9a65-3796-e053-2995a90a4f80	2024-10-16	Warnings	Exact identifier application number: M020
Wegmans Sheer Broad Spectrum SPF 30 Dry Touch Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WEGMANS FOOD MARKETS INC	f33248fa-695a-fbef-e053-2a95a90abe35	2024-10-16	Warnings	Exact identifier application number: M020
Wegmans Sport Sunscreen Stick SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WEGMANS FOOD MARKETS INC	f5671251-e26b-045f-e053-2a95a90adc03	2024-10-16	Warnings	Exact identifier application number: M020
Wegmans Kids Sunscreen Stick SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WEGMANS FOOD MARKETS INC	f57775c3-5e6c-f47a-e053-2a95a90ab012	2024-10-16	Warnings	Exact identifier application number: M020
Sunscreen ULTRA Broad Spectrum Equate	AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE	WAL-MART STORES INC.	68524d2b-284c-4a69-9b0e-8d2ad80822e2	2024-10-16	Warnings	Exact identifier application number: M020
Equate SPF 50 Ultra Sunscreen Continuous	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Wal-Mart Stores Inc	8fda6c78-1b39-6aa6-e053-2995a90a16a2	2024-10-16	Warnings	Exact identifier application number: M020
Equate SPF 70 Ultra Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Wal-Mart Stores Inc	8f24e301-3fce-f9e3-e053-2a95a90affe4	2024-10-16	Warnings	Exact identifier application number: M020
Equate SPF 50 Ultra Zinc Sunscreen	OCTOCRYLENE, ZINC OXIDE	Wal-Mart Stores Inc	8fdc0bad-8834-5b4a-e053-2a95a90a9fde	2024-10-16	Warnings	Exact identifier application number: M020
Equate SPF 50 Ultra Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Wal-Mart Stores Inc	8f02f297-5315-ced4-e053-2a95a90a8c7b	2024-10-16	Warnings	Exact identifier application number: M020
Equate SPF 70 Ultra Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Wal-Mart Stores Inc	9b655e56-33e5-45a3-9174-356fc717e39d	2024-10-16	Warnings	Exact identifier application number: M020
Equate Sunscreen SPF 70 SPORT Broad spectrum	AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE	Wal-Mart Stores Inc	e3181725-d04e-4a73-8871-9a1a9a11229c	2024-10-16	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