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	2026-10-27
excluded package	package	46783-002	46783-002-03	D	Discontinued by firm	2026-10-27
excluded package	package	46783-002	46783-002-05	D	Discontinued by firm	2026-10-27
excluded package	package	46783-002	46783-002-50	D	Discontinued by firm	2026-10-27

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 236 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Black Girl Sunscreen Sunscreen SPF 30 broad Spectrum	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Black Girl Sunscreen, LLC	2bc50182-30f5-b77e-e063-6394a90a6355	2025-01-15	Warnings	Exact identifier application number: M020
MEDIFORDEAR CICA CALMING SUNSCREEN	HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, AVOBENZONE	Youngwon Costech Co.,ltd.	2bc94923-b221-5159-e063-6394a90ab8ff	2025-01-15	Warnings	Exact identifier application number: M020
Meaningful Beauty Cindy Crawford Anti-Aging Day Creme with Environmental Protection Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OXYBENZONE	Meaningful Beauty, LLC	6423e1c7-85cd-46f8-8fc9-a7284e3577d1	2025-01-15	Warnings	Exact identifier application number: M020
Stay AgelessTinted Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	Spectrum Aesthetics Laser Training LLC	026b9b30-ef08-bf2e-e063-6394a90a54a6	2025-01-14	Warnings	Exact identifier application number: M020
Daily Sunscreen Broad Spectrum SPF 30 UVA UVB	MINERAL SUNSCREEN SPF 30	IHerb, LLC	2d8101ef-96a3-1463-e063-6294a90add4d	2025-01-14	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Tinted Mineral Sunscreen Face Stick Unscented SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0d85b0a1-3705-2829-e063-6394a90a0ed7	2025-01-13	Warnings	Exact identifier application number: M020
Attitude mineral sunscreen orange blossom SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0b85ea68-6113-4e92-a10a-39d13099d12d	2025-01-13	Warnings	Exact identifier application number: M020
Skinfuse Shield SPF 30	ZINC OXIDE	Owen Biosciences, Inc.	02d46d44-2476-4f96-9c72-783c392317de	2025-01-13		Exact identifier application number: M020
Chem Free SPF 30	ZINC OXIDE	Owen Biosciences, Inc.	7e5930fe-eb0f-4a21-8065-8831dd5b351c	2025-01-13	Warnings	Exact identifier application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 Shell	ZINC OXIDE	EVER FAME PTE. LTD.	2b9b5a73-858e-78dd-e063-6394a90ad082	2025-01-13	Warnings	Exact identifier application number: M020
Tula Skincare protect and go dewy glow sunscreen stick broad spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	2b9acb63-b32c-336c-e063-6394a90a4a9c	2025-01-13	Warnings	Exact identifier application number: M020
Brush and Go All Skin types	TITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONE	Noon Aesthetics M.R. Ltd	9ee5b3c2-4369-4c4b-ab55-b52661b82188	2025-01-13	Warnings	Exact identifier application number: M020
Priia Tinted Mineral Sunscreen and Primer	TITANIUM DIOXIDE, ZINC OXIDE	Priia Cosmetics Inc	5c4219ac-d65f-43a5-8ec4-8732b9b344cf	2025-01-13	Warnings	Exact identifier application number: M020
Brush and Go Oily Problematic Skin	TITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONE	Noon Aesthetics M.R. Ltd	b4295453-f193-4bed-be5b-efcd91772107	2025-01-13	Warnings	Exact identifier application number: M020
Zealios SPF LipGuard	OCTISALATE AND AVOBENZONE	Personal Best Products Inc. dba Zealios	3a07822b-a7c9-40af-a8f7-bea591c7a49b	2025-01-13	Warnings	Exact identifier application number: M020
SPF-30 BB	ZINC OXIDE	ZION HEALTH	66d33d8c-8900-4698-98fe-0dedafe674d8	2025-01-13	Warnings	Exact identifier application number: M020
Priia Tinted Mineral Sunscreen and Primer	TITANIUM DIOXIDE, ZINC OXIDE	Priia Cosmetics Inc	b2addf27-9139-48b4-85e6-618f4b5311cc	2025-01-13	Warnings	Exact identifier application number: M020
Skin Apeel Ageless Defense SPF 40 Broad Spectrum	ZINC OXIDE	Skin Apeel, Inc.	c3bbe779-b012-4f19-8b90-2c7a4dd88617	2025-01-13	Warnings	Exact identifier application number: M020
UNCOMPLIKATED MAKEUP SETTING SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	KATE SOMERVILLE SKINCARE LLC	1a33cb41-440a-41cb-9832-24255bfa2b7c	2025-01-12	Warnings	Exact identifier application number: M020
ALLSWELL MINERAL SUNSCREEN SPF 30	ZINC OXIDE	Stream2Sea, LLC	03bee988-d6e3-4290-a926-9c5366649cba	2025-01-12	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