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	2026-10-21
excluded package	package	46783-002	46783-002-03	D	Discontinued by firm	2026-10-21
excluded package	package	46783-002	46783-002-05	D	Discontinued by firm	2026-10-21
excluded package	package	46783-002	46783-002-50	D	Discontinued by firm	2026-10-21

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 158 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetaphil Sun Tinted Face SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	Galderma Laboratories, L.P.	22413f93-7219-4726-b741-2392e576b34a	2025-11-24	Warnings	Exact identifier application number: M020
VEIL MINERAL PRIMER SUNSCREEN BROAD SPECTRUM SPF 15	ZINC OXIDE AND TITANIUM DIOXIDE	Kingdom Animalia, LLC DBA Hourglass Cosmetics	28e23498-953f-47c0-838c-bbf0e858d903	2025-11-24	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	203c9d86-45d7-efcc-e063-6394a90acefb	2025-11-23	Warnings	Exact identifier application number: M020
Aveeno Protect Plus Hydrate Sunscreen Broad Spectrum Body SPF 60	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	615c5349-7fff-4145-9d65-1687247163be	2025-11-21	Warnings	Exact identifier application number: M020
Aveeno Protect Plus Hydrate Sunscreen Broad Spectrum Face SPF 60	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	3cee59ad-f5e1-487d-b9cc-597664c62dac	2025-11-21	Warnings	Exact identifier application number: M020
Aveeno Protect Plus Hydrate Sunscreen Broad Spectrum Body SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	0e905f47-a1d8-4c5a-8247-d7328d2cb4af	2025-11-21	Warnings	Exact identifier application number: M020
SPF 50 Sport Sunscreen GoodSense	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Geiss, Destin, & Dunn, Inc	a22baebd-1f4d-6eae-e053-2a95a90afe51	2025-11-21	Warnings	Exact identifier application number: M020
Everyday Sun Defense	ZINC OXIDE	Hommerejuvenate, Inc.	05aa1a1a-9e4f-2781-e063-6394a90aef6b	2025-11-21	Warnings	Exact identifier application number: M020
innisfree Daily UV Defense Sunscreen	AVOBENZONE, HOMOSALATE, AND OCTISALATE LOTION	Innisfree Corporation	0e9b6697-28a3-f69f-e063-6394a90a9d11	2025-11-20	Warnings	Exact identifier application number: M020
SULWHASOO PERFECTING CUSHION NO. 25	OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE	Amorepacific Corporation	8d420e4b-c778-3ed4-e053-2995a90a59a9	2025-11-20	Warnings	Exact identifier application number: M020
Protect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30	TITANIUM DIOXIDE, ZINC OXIDE	Norwex Usa, Inc.	f527a8c5-b05e-5f3c-e053-2995a90aa1a3	2025-11-20	Warnings	Exact identifier application number: M020
Norwex Lip Glaze Broad Spectrum SPF 30 Hazelnut	ZINC OXIDE	Norwex Usa, Inc.	440bd831-ee0b-b527-e063-6294a90a9333	2025-11-20	Warnings	Exact identifier application number: M020
PRO-COLLAGEN SKIN PROTECTION FLUID SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	Elemis Ltd.	23f9222f-60ba-72fb-e063-6394a90a9965	2025-11-20	Warnings	Exact identifier application number: M020
AussieZinc Mineral Sunscreen Vegan and Organic Mozzie Repellant	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	36ca866e-adc3-5a4f-e063-6394a90a1d1d	2025-11-20	Warnings	Exact identifier application number: M020
Sandra Plasencia Green Tea Daily SPF 50 Moisturizer	TITANIUM DIOXIDE	Sandra Plasencia Skincare	43ef1f93-0e89-0a35-e063-6394a90afb51	2025-11-19	Warnings	Exact identifier application number: M020
Sunkissed by Heaven Unscented Sunscreen SPF 50	ZINC OXIDE	Sunkissed By Heaven, LLC	09dbd05a-dd07-43c3-b3d0-68f8f4b3e86d	2025-11-19	Warnings	Exact identifier application number: M020
KOVR Military grade sunscreen for women	ZINC OXIDE	ACTIVE LIFE INC	4d0691ad-ca1b-4ca7-b94a-7bbaaf6f6dae	2025-11-19	Warnings	Exact identifier application number: M020
Dynamic Resurfacing SPF 30	AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE	ELEMIS Limited	fc64720c-060c-4f33-8c76-96456fac270d	2025-11-19	Warnings	Exact identifier application number: M020
Daily Defence Shield SPF 30	AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE	ELEMIS Limited	b2b6de93-47c8-4b6e-9fb9-8bdc8909271a	2025-11-19	Warnings	Exact identifier application number: M020
Duke Cannon Supply Co. Daily Defense Face Mineral Sunscreen Broad Spectrum SPF 32	ZINC OXIDE	DUKE CANNON SUPPLY CO.	0c47278b-2ec2-81ab-e063-6294a90ac937	2025-11-19	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