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 317 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Slip Tint Broad Spectrum SPF 35 Tinted Moisturizer	ZINC OXIDE	Clean Beauty For All, Inc	ccf9daf4-0bf0-2610-e053-2a95a90a3f07	2023-12-12	Warnings	Exact identifier application number: M020
MINERAL BODY SUNSCREEN UNSCENTED	ZINC OXIDE	Synchronicity Spa, Inc. DBA Suntegrity	17cb6a73-5bfe-4227-ab9f-f6dd90bac266	2023-12-12	Warnings	Exact identifier application number: M020
Vichy Laboratoires Capital Soleil 60 Mineral Sunscreen Broad Spectrum SPF 60 Water Resistant 80 Minutes Sheer Tint Ultra Lightweight	TITANIUM DIOXIDE	LOreal USA Products Inc	4692b146-1abe-48e8-b097-ea9c556962b6	2023-12-11	Warnings	Exact identifier application number: M020
Vichy Laboratories LiftActiv Peptide-C SPF 30 Phyto Peptides Vitamin C	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	40fd5146-f4f0-4c2d-a786-d18f8ade1bef	2023-12-11	Warnings	Exact identifier application number: M020
Vichy Laboratories LiftActiv Peptide-C SPF 30 Sunscreen Phyto Peptides Vitamin C	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	Cosmetique Active Products	f5b3e52e-64f7-4e97-ba74-60de904b8771	2023-12-11	Warnings	Exact identifier application number: M020
Vichy Laboratoires Capital Soleil 60 Mineral Broad Spectrum SPF 60 Water Resistant 80 Minutes Sheer Tint Ultra Lightweight Sunscreen	TITANIUM DIOXIDE	Cosmetique Active Production	acb887bc-7e46-4257-9fe3-a2cade6c4f38	2023-12-11	Warnings	Exact identifier application number: M020
Solar Defense Body	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	HydroPeptide LLC	45ec77c5-5eb3-0e51-e054-00144ff8d46c	2023-12-09	Warnings	Exact identifier application number: M020
Erborian BB creme au Ginseng chocolate SPF 20	OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	ddcd6ea4-e7b1-88df-e053-2a95a90a9923	2023-12-09	Warnings	Exact identifier application number: M020
ERBORIAN - BB CREME AU GINSENG CARAMEL SPF20	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	43c81760-6bb6-25fe-e054-00144ff8d46c	2023-12-09	Warnings	Exact identifier application number: M020
Erborian CC Dull Correct SPF25	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	cb23ba95-1e83-4523-a35c-3b70c0605dd1	2023-12-09	Warnings	Exact identifier application number: M020
Carmex Classic Lip Balm Medicated Free Wintergreen Stick	OCTINOXATE, OXYBENZONE, CAMPHOR (SYNTHETIC), WHITE PETROLATUM	Carma Laboratories, Inc.	bc0162bc-92ca-ee78-e053-2a95a90a7c9d	2023-12-08	Warnings	Exact identifier application number: M020
Raw Elements Eco Formula SPF30 Sample Packs	ZINC OXIDE	Raw Elements LLC	9e91e228-0b5e-4577-9d57-cdb9e9a705e8	2023-12-08	Warnings	Exact identifier application number: M020
Multi-Active Jour SPF 20 Broad Spectrum Sunscreen	AVOBENZONE,HOMOSALATE,OCTOCRYLENE	Laboratoires Clarins	432f07e8-6f0f-4946-b1b6-4559ef1af561	2023-12-08	Warnings	Exact identifier application number: M020
CLARINS - EXTRA-FIRMING JOUR SPF 15 - Wrinkle, Firming Day all skin types - Broad Spectrum SPF 15 Sunscreen	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Laboratoires Clarins	ae34fdcb-d372-435f-bf7c-075ea554b2fe	2023-12-08	Warnings	Exact identifier application number: M020
UV ESSENTIEL COMPLETE UV PROTECTION SUNSCREEN ANTIOXIDANT ANTI-POLLUTION BROAD SPECTRUM SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	CHANEL PARFUMS BEAUTE	df2a43b4-eab9-48cd-a4b6-d00cfc925477	2023-12-08	Warnings	Exact identifier application number: M020
SERIOUS SKINCARE SERIOUS-C3 PLASMA TM BIO TECHNOLOGY C VITAMIN C ESTER PROTECTIVE DAYTIME BROAD SPECTRUM MOISTURIZER SPF 30	AVOBENZONE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE	Flageoli Limited	4833b0b1-33b7-59d4-e054-00144ff8d46c	2023-12-07	Warnings	Exact identifier application number: M020
Cetaphil Sheer Mineral Sunscreen SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Galderma Laboratories, L.P.	ac2d5713-9955-477e-a10f-e8a1191b5fdd	2023-12-07	Warnings	Exact identifier application number: M020
CLARINS BROAD SPECTRUM SPF 50 Sunscreen Body	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE,	Laboratoires Clarins	7feb0679-6557-4917-a386-7ce2c14a94e2	2023-12-06	Warnings	Exact identifier application number: M020
CLARINS BROAD SPECTRUM SPF 50 Dry Touch Facial Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Laboratoires Clarins	5bddb1d6-2493-41bf-8c14-73f103c55aa7	2023-12-05	Warnings	Exact identifier application number: M020
Sea Clearly Hydrating Facial SPF 35 Kinetin	OCTOCRYLENE, OCTISALATE,HOMOSALAT, AVOBENZONE	Allure Labs	0bc829ff-34a0-03e9-e063-6294a90a10ae	2023-12-05	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