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 217 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
No7 Lift and Luminate Triple Action Fragrance Free Day Cream SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	BCM Cosmetique SAS	32b5a19e-86d4-5ee1-e063-6394a90a12e2	2025-04-11	Warnings	Exact identifier application number: M020
LERINN ZINCPURE SUNMILK SPF 50	ZINC OXIDE	Serrina Lin Skincare Inc	32717b49-729c-a229-e063-6394a90a18fb	2025-04-10	Warnings	Exact identifier application number: M020
Smoothing Mineral Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	DANIEL BEHROOZAN MD A MEDICAL CORPORATION	327246c2-9d7a-2d34-e063-6294a90a5fb7	2025-04-10		Exact identifier application number: M020
Clarity Rx Physical Skin Defense SPF 50	ZINC OXIDE AND TITANIUM DIOXIDE	Topiderm, Inc.	b5111012-97b9-4908-95a0-d09595f9c4d9	2025-04-10	Warnings	Exact identifier application number: M020
Tinted Mineral Sunscreen SPF 50	ZINC OXIDE AND TITANIUM DIOXIDE	Topiderm, Inc.	13e5085f-df2b-46b2-b063-e58ce4379905	2025-04-09	Warnings	Exact identifier application number: M020
Sunstation Sport Sunscreen SPF 30	OCTOCRYLENE, ZINC OXIDE, OCTISALATE	Sunstation USA LLC	6007c125-f28a-45e5-b8f1-490ee04b7811	2025-04-09	Warnings	Exact identifier application number: M020
Pacifica Sun Dreams Illuminating SPF Foam	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Pacifica Beauty, LLC	2e0cb105-75c3-8032-e063-6394a90ab502	2025-04-09	Warnings	Exact identifier application number: M020
belif Aqua bomb - glow sunstick SPF50	HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE	LG H&H CO., LTD.	284cadf1-deb9-4f3d-e063-6394a90ab122	2025-04-09	Warnings	Exact identifier application number: M020
ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (ROSA ROMANTICA FEMME) - PINK	OCTINOXATE AND OXYBENZONE	Ventura Corporation LTD	aa79b1a4-6b33-47c9-b55e-b813d9b22265	2025-04-09	Warnings	Exact identifier application number: M020
Brush On Block SPF 30 Mineral Powder Touch of Tan Zinc Only	ZINC OXIDE	SPF Ventures, LLC	3240cbe5-bfc8-17f7-e063-6394a90a1b98	2025-04-08	Warnings	Exact identifier application number: M020
ISA KNOX UV SUN PRO 365 Sheer Mineral Face	ZINC OXIDE	LG HOUSEHOLD & HEALTH CARE LTD.	2eeac795-b74e-b3a3-e063-6294a90abf52	2025-04-08	Warnings	Exact identifier application number: M020
The Face Shop Hydro Sun Barrier 2-in-1 SPF and Moisturizer	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG HOUSEHOLD & HEALTH CARE LTD.	2ee9f271-b508-2304-e063-6294a90a3752	2025-04-08	Warnings	Exact identifier application number: M020
CLARINS Multi-Active Jour Niacinamide and Sea Holly Extract Sunscreen SPF 15	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Laboratoires Clarins	a43d0d4f-94de-4c4b-a17a-63a819d5d293	2025-04-07	Warnings	Exact identifier application number: M020
Gangnam Glow Sunscreen 50	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	LG HOUSEHOLD & HEALTH CARE LTD.	30cc2e35-f752-8285-e063-6294a90afbf5	2025-04-07	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	26f8dc88-2096-4fa1-81ae-ea92fe1f353d	2025-04-07	Warnings	Exact identifier application number: M020
Vacation Instant Browning	AVOBENZONE OCTISALATE OCTOCRYLENE	Vacation Inc.	13028f61-3f62-22cc-e063-6394a90a6bf1	2025-04-04	Warnings	Exact identifier application number: M020
LBri Pure n Natural SPF 30	ZINC OXIDE	L'BRI HEALTH & BEAUTY	8350791d-5cf2-4358-9f85-9384d35be9f4	2025-04-03	Warnings	Exact identifier application number: M020
SHEER MINERAL SUNSCREEN	ZINC OXIDE	Plant Devas Inc. dba evanhealy	f620ef44-f30c-4cc9-bc82-28dc4a47a8da	2025-04-02	Warnings	Exact identifier application number: M020
CLEAR GLOW BROAD SPECTRUM SUNCREEN SPF 50	AVOBENZONE, HOMOSALATE OCTISALATE, OCTOCRYLENE	NAKED SUNDAYS PTY LTD	0116cffa-3415-746b-e063-6394a90ab3b3	2025-04-01	Warnings	Exact identifier application number: M020
HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50 SPF 50	AVOBENZONE, HOMOSALATE OCTISALATE,	NAKED SUNDAYS PTY LTD	04293280-e74a-f293-e063-6394a90a06f6	2025-04-01	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