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	2026-10-23
excluded package	package	46783-002	46783-002-03	D	Discontinued by firm	2026-10-23
excluded package	package	46783-002	46783-002-05	D	Discontinued by firm	2026-10-23
excluded package	package	46783-002	46783-002-50	D	Discontinued by firm	2026-10-23

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 202 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Face Reality Power Mineral Sunscreen SPF 50	ZINC OXIDE	Face Reality,LLC	8c502e11-6e97-46d6-8775-1bbafaeb18f8	2025-07-29	Warnings	Exact identifier application number: M020
SPF30 unseen sunscreen stick 01	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	3afa3bdb-e924-55c1-e063-6394a90af352	2025-07-28	Warnings	Exact identifier application number: M020
Neutrogena Mineral Invisible Daily Defense Face Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Kenvue Brands LLC	003123d2-9675-fdd2-e063-6294a90a0130	2025-07-28	Warnings	Exact identifier application number: M020
Neutrogena Mineral Ultra Sheer Face SPF 70	TITANIUM DIOXIDE, ZINC OXIDE	Kenvue Brands LLC	20e0badf-fe25-1d27-e063-6294a90a7cfe	2025-07-28	Warnings	Exact identifier application number: M020
Basin Santas Cookies SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3b016dcf-fb74-916f-e063-6294a90a683d	2025-07-28	Warnings	Exact identifier application number: M020
Basin Vanilla SPF 30 Broad Spectrum Sunscreen Lip Balm SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Retail Concepts of Minnesota, Inc.	3b01c6a4-2230-c83e-e063-6294a90aa66d	2025-07-28	Warnings	Exact identifier application number: M020
Basin Peppermint Swirl SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3b022c84-00a5-ece9-e063-6294a90a09bd	2025-07-28	Warnings	Exact identifier application number: M020
Basin Winter Berry Blast SPF15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3b02c3f2-a43a-0d29-e063-6394a90a76b5	2025-07-28	Warnings	Exact identifier application number: M020
KARA VITA Moisturizing Sunscreen with DNArescue	OXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE	Kara Vita, Inc.	2130e9ac-5946-4b00-94d0-a78fd1ccfd13	2025-07-25	Warnings	Exact identifier application number: M020
78 x 36 SPF 30 Active	ZINC OXIDE	Dermazone LLC	96a8aacc-5c2f-410a-8fb4-8b3bc0f81e55	2025-07-25	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 01N Light	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	2ccf4e45-4cec-417d-9f4c-28f376025f1d	2025-07-25	Warnings	Exact identifier application number: M020
celazome Moisturizing SPF 30 Active	OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE	Dermazone LLC	5ec1510d-1465-4849-9e23-f16e11ff0e65	2025-07-25	Warnings	Exact identifier application number: M020
Skinuva Scar plus	ZINC OXIDE	MD Medical Designs, Inc.	5fcad8c3-a268-4966-b0a9-6cd2c7afd3b7	2025-07-25	Warnings	Exact identifier application number: M020
celazome Moisturizing SPF 29 Active with DNArescue	OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE	Dermazone LLC	99fb90ca-6527-459b-8af2-627ea9abe11b	2025-07-25	Warnings	Exact identifier application number: M020
The Men Pen TALLOW GUARD SPF 30 PREMIUM ZINC SUNSCREEN	ZINC OXIDE	Guangzhou Haishi Biological Technology Co., Ltd.	3aa93f52-ec01-01c2-e063-6294a90a9347	2025-07-24	Warnings	Exact identifier application number: M020
Mineral Suscreen SPF 30	ZINC OXIDE 19.0%	Vivant Pharmaceuticals, LLC	3aadb658-d12d-ae8d-e063-6394a90a6496	2025-07-24	Warnings	Exact identifier application number: M020
Sunscreen	TITANIUM DIOXIDE 6.8%	Baxter of California, LLC	146030bc-2bf4-25ea-e063-6294a90a4613	2025-07-24	Warnings	Exact identifier application number: M020
Leg and Body Makeup Broad Spectrum SPF 25	OCTISALATE 3.2% OCTOCRYLENE 6%	Baxter of California, LLC	14adc826-6e9d-382a-e063-6294a90a5d79	2025-07-24	Warnings	Exact identifier application number: M020
Tiege Hanley AM Morning Facial Moisturizer with SPF 20	AVOBENZENE, OCTINOXATE, OCTOCRYLENE	TIEGE HANLEY, Inc	22086cd8-2126-120e-e063-6394a90a561e	2025-07-24	Warnings	Exact identifier application number: M020
Tulip Dew SHIELD GLOW	ZINC OXIDE	Bloomeffects, Inc.	150f9660-48ec-a189-e063-6294a90a6d49	2025-07-23	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