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 302 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SOLVADERM Dermaxsol Dermal Defense Moisturizer SPF-30	OCTOCRYLENE, ZINC OXIDE	SOLVADERM LLC	0f9a507a-1b72-45f8-a8a8-b7a92a85607f	2024-03-21	Warnings	Exact identifier application number: M020
Daily Prevention Protect and Refresh Mist SPF 40	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	Allure Labs	142f99de-176e-ad11-e063-6394a90a935b	2024-03-21	Warnings	Exact identifier application number: M020
PHYSIOGEL Daily Moisture Therapy Barrier Mineral Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	fmg Co.Ltd	1410c6d9-eff0-f90b-e063-6394a90a9403	2024-03-20	Warnings	Exact identifier application number: M020
ETADERM Tattoo Sunscreen Broad Spectrum SPF-30	ZINC OXIDE	NUEPHASE LLC	cc1e3485-57e6-4ac9-96b3-2d683beb5b53	2024-03-20	Warnings	Exact identifier application number: M020
Daily Prevention Advanced Smartblend Mineral Moisturizer SPF 75	TITANIUM DIOXIDE AND ZINC OXIDE	Allure Labs	141bb721-cd1c-5bba-e063-6394a90ab8fa	2024-03-20	Warnings	Exact identifier application number: M020
Sunscreen-Lotion	ZINC OXIDE, TITANIUM DIOXIDE	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	0511ff57-b7bd-4708-e063-6294a90a58a8	2024-03-20	Warnings	Exact identifier application number: M020
Daily Prevention Ultra Defense Moisturizer SPF 50	HOMOSALATE, OCTISALATE,OCTOCRYLENE AND ZINC OXIDE	Allure Labs	14070076-8c57-e2f1-e063-6394a90a0dfc	2024-03-19	Warnings	Exact identifier application number: M020
PHYSIOGEL Daily Moisture Therapy Barrier Mineral Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	LG H&H Co., Ltd.	140feb1e-a72f-ade4-e063-6394a90a11fb	2024-03-19	Warnings	Exact identifier application number: M020
Daily Prevention Sheer Matte Moisturizer SPF30	HOMOSALATE AND OCTISALATE AND ZINC OXIDE	Allure Labs	13b5c78c-f950-699b-e063-6294a90a9898	2024-03-15	Warnings	Exact identifier application number: M020
Daily Prevention Pure Mineral Tinted Moisturizer SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	Allure Labs	13bc141b-a30f-2661-e063-6294a90aca2b	2024-03-15	Warnings	Exact identifier application number: M020
BB Ambre 30 BS SPF30	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs	13a3ec97-0d0a-d639-e063-6294a90a0bf8	2024-03-14	Warnings	Exact identifier application number: M020
Mineral Shake	ZINC OXIDE	Vacation Inc.	131b7e65-7155-f925-e063-6394a90a1d7a	2024-03-13	Warnings	Exact identifier application number: M020
BB Blanc 30 BS SPF30	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs	137a1528-c487-8bf3-e063-6294a90ade84	2024-03-12	Warnings	Exact identifier application number: M020
BB Sienna 30 BS SPF30	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs	137bff4a-5156-b12c-e063-6394a90abe63	2024-03-12	Warnings	Exact identifier application number: M020
Vacation Super	AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE	Vacation Inc.	137c350b-dca1-47f7-e063-6294a90a531e	2024-03-12	Warnings	Exact identifier application number: M020
Avene Hydrance Moisturizing SPF 30	ZINC OXIDE	Pierre Fabre USA Inc.	1361ebe5-2659-d88f-e063-6294a90a71bb	2024-03-11	Warnings	Exact identifier application number: M020
BB Brite 30 BS SPF30	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs	13660aee-3b28-7e3e-e063-6294a90a82cc	2024-03-11	Warnings	Exact identifier application number: M020
BB Bronze 30 BS SPF30	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs	13679e50-01ef-9a8f-e063-6294a90ac577	2024-03-11	Warnings	Exact identifier application number: M020
Advanced Firming And Anti-Wrinkle Day SPF 18 EQB	AVOBENZONE 2% OCTISALATE 5% OCTOCRYLENE 5%	Walmart	358dfed4-1c6d-400e-8e6f-331fbc76a834	2024-03-11	Warnings	Exact identifier application number: M020
Avene Mineral Sunscreen Stick SPF 50	ZINC OXIDE	Pierre Fabre USA Inc.	1368482f-3a72-ffa9-e063-6394a90a603e	2024-03-11	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