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 300 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SPF30 Sunscreen Cariposa	TITANIUM DIOXIDE, ZINC OXIDE	Talent Brands Company LLC	37d696d9-f89d-498e-8fe9-1f08d05d7b61	2024-04-18	Warnings	Exact identifier application number: M020
Cetaphil Daily Facial Moisturizer with suncreen SPF 50	OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE	Galderma Laboratories, L.P.	6650d137-e69e-4ec2-8311-3de74bf21315	2024-04-17	Warnings	Exact identifier application number: M020
Eco Lips PlantPod Sunscreen Lip Balm Berry SPF 15	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Eco Lips. Inc.	e5e84e60-4339-460d-e053-2a95a90ad152	2024-04-17	Warnings	Exact identifier application number: M020
Eco Lips PlantPod Sunscreen Lip Balm Mint SPF 15	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Eco Lips. Inc.	e64c4a2d-134e-999a-e053-2a95a90a64ee	2024-04-17	Warnings	Exact identifier application number: M020
SPF 30 Mineral Sunscreen Cariposa	TITANIUM DIOXIDE, ZINC OXIDE	Talent Brands Company LLC	0bc21573-d302-4d85-8d8f-dca9a48e1f35	2024-04-17	Warnings	Exact identifier application number: M020
Differin Oil Absorbing Moisturizer SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Galderma Laboratories, L.P.	4d5978c7-3575-4b5b-97bd-5f3c89412baf	2024-04-17	Warnings	Exact identifier application number: M020
Cancer Council Everyday Active SPF50 Plus	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Vitality US Co.	16381c8f-f954-f0be-e063-6394a90ae401	2024-04-16	Warnings	Exact identifier application number: M020
The Nethercutt Collection Sunscreen Stick SPF 30 Broad Spectrum Sunscreen SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Eco Lips. Inc.	163a2994-d95a-5752-e063-6394a90aec5d	2024-04-16	Warnings	Exact identifier application number: M020
The Nethercutt Collection Hemp Vanilla SPF 30 Broad Spectrum Sunscreen Lip Balm SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Eco Lips. Inc.	163ac1c1-7403-9d60-e063-6294a90a1cc0	2024-04-16	Warnings	Exact identifier application number: M020
Cetaphil	OCTOCRYLENE, AVOBENZONE	Galderma Laboratories, L.P.	2a6bc3f2-4e52-252b-d051-94be1ee0cc00	2024-04-16	Warnings	Exact identifier application number: M020
Cetaphil Oil Absorbing SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Galderma Laboratories, L.P.	73ed545b-460f-4287-8643-a02b0641fd45	2024-04-16	Warnings	Exact identifier application number: M020
SUN CONTROL BROAD SPECTRUM SPF 30	HOMOSALATE, OCTISALATE, ZINC OXIDE	SKINPLAN.US LLC	8e34a343-7253-469f-9973-076a7ae26cbc	2024-04-15	Warnings	Exact identifier application number: M020
Cancer Council Protect and Hydrate Radiance SPF50 Plus	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Vitality US Co.	1622c351-6e69-eeaf-e063-6294a90acd25	2024-04-15	Warnings	Exact identifier application number: M020
Hydrating Mineral Sunscreen BS SPF30	ZINC OXIDE	Allure Labs	16268c31-2151-20e0-e063-6294a90a7965	2024-04-15	Warnings	Exact identifier application number: M020
Cancer Council Daily Body Moisturizer SPF50 Plus	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Vitality US Co.	16296d3e-286a-e015-e063-6394a90a4189	2024-04-15	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	Cosmetique Active Production	f9645435-e138-45df-a5ec-6dc7b3ff792d	2024-04-08	Warnings	Exact identifier application number: M020
Degil Sun SPF 50 Sunscreen	HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE	Degil Safety Products (1989) Inc	155aa0c5-6403-ee86-e063-6294a90a1c4d	2024-04-05	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip SPF 15 Assorted	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Carma Laboratories, Inc.	ff9eae5b-4963-429d-bb73-8e3b5402f084	2024-04-05	Warnings	Exact identifier application number: M020
Lemongrass Spa Products SPF 45 Mineral Sunscreen	ZINC OXIDE	Lemongrass Spa Products	15469260-d4e5-8423-e063-6394a90aafae	2024-04-04	Warnings	Exact identifier application number: M020
Clearly Zinq Tinted Hydrating Facial SPF Growth Factor 35	ZINC OXIDE	Allure Labs	1548faf9-8623-f871-e063-6394a90a931f	2024-04-04	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