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	2026-10-20
excluded package	package	46783-002	46783-002-03	D	Discontinued by firm	2026-10-20
excluded package	package	46783-002	46783-002-05	D	Discontinued by firm	2026-10-20
excluded package	package	46783-002	46783-002-50	D	Discontinued by firm	2026-10-20

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 119 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Join
Complexion Correction Primer Sunscreen clear	TITANIUM DIOXIDE, ZINC OXIDE	MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY	357eee3c-1c21-5efb-e063-6294a90a4bb7	2025-12-15	Exact identifier application number: M020
Complexion Correction Tinted Primer Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY	357e75ec-473e-df76-e063-6294a90a70c7	2025-12-15	Exact identifier application number: M020
Complexion Correction Tinted Primer Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY	357f2f62-904a-2234-e063-6394a90aee72	2025-12-15	Exact identifier application number: M020
Superscreen Daytime Mineral Sunscreen	ZINC OXIDE	MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY	357f915a-bd77-350b-e063-6294a90ad27f	2025-12-15	Exact identifier application number: M020
Complexion Correction Primer Sunscreen clear	TITANIUM DIOXIDE, ZINC OXIDE	MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY	357ff025-84ad-6d77-e063-6394a90aad95	2025-12-15	Exact identifier application number: M020
Complexion Correction Tinted Primer Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY	358021a2-235b-825b-e063-6394a90a76f5	2025-12-15	Exact identifier application number: M020
Superscreen Daytime Mineral Sunscreen	ZINC OXIDE	MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY	35805e66-18e6-0e45-e063-6294a90afe58	2025-12-15	Exact identifier application number: M020
Ultra Zinc Physical Defense	ZINC OXIDE	ATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER	35474ac4-8a9d-6a84-e063-6394a90a9bad	2025-12-15	Exact identifier application number: M020
Ultra Zinc Physical Defense	ZINC OXIDE	ATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER	357e315e-8802-ad73-e063-6394a90a2495	2025-12-15	Exact identifier application number: M020
Tinted Physical Defense	TITANIUM DIOXIDE, ZINC OXIDE	ATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER	35477ed2-0875-58d5-e063-6294a90a3d5d	2025-12-15	Exact identifier application number: M020
Anti Aging Daily Protection	ZINC OXIDE	LEVERRIER, KAMILA	35465f21-8bcd-6e44-e063-6294a90a8e5f	2025-12-15	Exact identifier application number: M020
Anti Aging Daily Protection	ZINC OXIDE	LEVERRIER, KAMILA	3546d369-3435-b56a-e063-6294a90a0843	2025-12-15	Exact identifier application number: M020
Tinted Facial Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	HELTON SKIN & LASER INSTITUTE	35a97770-2db9-99aa-e063-6294a90a459a	2025-12-15	Exact identifier application number: M020
Tinted Replenishing Daily Protection	ZINC OXIDE	HELTON SKIN & LASER INSTITUTE	35a9d07d-70e5-5eed-e063-6394a90aebaf	2025-12-15	Exact identifier application number: M020
Non-Tinted Sports Stick	TITANIUM DIOXIDE, ZINC OXIDE	HELTON SKIN & LASER INSTITUTE	35aa833a-19a1-99e9-e063-6394a90a840f	2025-12-15	Exact identifier application number: M020
Tinted Facial Primer	TITANIUM DIOXIDE, ZINC OXIDE	BEE NATURALS	36c3352e-fa51-19ad-e063-6394a90a591b	2025-12-15	Exact identifier application number: M020
Luminous Tinted Moisturizing	ZINC OXIDE	SKIN BOSS L.L.C.	35a8ae26-82eb-e4ca-e063-6394a90a0022	2025-12-15	Exact identifier application number: M020
Restore Tinted Moisturizing	ZINC OXIDE	SKIN BOSS L.L.C.	35a8e92e-ced2-fdcd-e063-6294a90acedc	2025-12-15	Exact identifier application number: M020
Velvet Tinted Moisturizing Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	SKIN BOSS L.L.C.	35a871dc-a707-9963-e063-6294a90a4396	2025-12-15	Exact identifier application number: M020
Velvet NT Moisturizing Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	SKIN BOSS L.L.C.	35a8508d-7069-c2d6-e063-6394a90a6219	2025-12-15	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