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	2026-10-16
excluded package	package	46783-002	46783-002-03	D	Discontinued by firm	2026-10-16
excluded package	package	46783-002	46783-002-05	D	Discontinued by firm	2026-10-16
excluded package	package	46783-002	46783-002-50	D	Discontinued by firm	2026-10-16

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 70 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RODAN AND FIELDS REVERSE 4 BROAD SPECTRUM SPF 50 PLUS SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Rodan & Fields	7fe05ef6-dd5f-4f25-bbf7-24f939642707	2026-01-23	Warnings	Exact identifier application number: M020
Ceile SPF 30 prime PROTECT RADIATE Broad Spectrum SPF 30 Sunscreen Nacre	CEILE SPF 30 PRIME PROTECT RADIATE NACRE	LE COSMETICS INC	4915de09-3a2c-cb75-e063-6394a90a6a57	2026-01-23	Warnings	Exact identifier application number: M020
SPF 50 Sunscreen Stick	ZINC OXIDE	Australian Gold	248d761c-2120-4019-9463-9952bc367e73	2026-01-23	Warnings	Exact identifier application number: M020
SOLBAR THIRTY	SUNSCREEN	Person and Covey	48ed3be8-d146-ec2c-e063-6394a90a6c4d	2026-01-22	Warnings	Exact identifier application number: M020
MISSHA ALL AROUND ESSENCE SUNSCREEN	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Able C&C Co., Ltd.	48f557b5-a844-8c94-e063-6394a90af220	2026-01-22	Warnings	Exact identifier application number: M020
MISSHA GLOW DEWY HDRATING SUNSCREEN	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Able C&C Co., Ltd.	48f5e9ab-38e0-f12c-e063-6294a90aab8b	2026-01-22	Warnings	Exact identifier application number: M020
MISSHA GLOW WEIGHTLESS PRIMING SUNSCREEN	ZINC OXIDE, HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE	Able C&C Co., Ltd.	48f6361d-d738-62df-e063-6294a90aaac5	2026-01-22	Warnings	Exact identifier application number: M020
SOLBAR SUNSCREEN 35 AVO	SUNSCREEN	Person and Covey	4a5692d5-0835-d18f-e063-6394a90a2929	2026-01-22	Warnings	Exact identifier application number: M020
Sunscreen Lip Balm SPF15	OCTINOXATE, AVOBENZONE, OCTISALATE	Dongguan Taimeng Accessories Co., Ltd.	48f70710-7960-5fa5-e063-6394a90a4ce6	2026-01-22	Warnings	Exact identifier application number: M020
SOLBAR SUNSCREEN 40 ZINC	SUNSCREEN	Person and Covey	48fc01dd-0be4-5c63-e063-6294a90a2362	2026-01-22	Warnings	Exact identifier application number: M020
SOLBAR SUNSCREEN 40 SHIELD	SUNSCREEN	Person and Covey	48fcd463-8ce4-1e78-e063-6394a90a98e7	2026-01-22	Warnings	Exact identifier application number: M020
SOLBAR SUNSCREEN 50 FIFTY	SUNSCREEN	Person and Covey	48fef521-1b24-d0d5-e063-6394a90ac7b1	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 110	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	7456f4bb-d0ec-439d-b807-d00b4c01c111	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 121	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	2dd51960-515f-4502-b261-5e5d5f57e091	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 140	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	5b835716-af13-4e23-bdae-d391864acb6f	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 132	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	fa258570-ee21-423d-bad6-010d14792a86	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 212	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	fa84c1b5-a9b6-408e-b9fd-0dadebaf374e	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 221	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	6b7a016c-c3b1-4f90-80c9-fe47c5291649	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 151	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	5d029d93-7f3d-4624-bcd7-40df9230414e	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 232	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	8f724d68-3c6e-4b95-894e-78b2da220a30	2026-01-22	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.	2026-05-20	HUMAN OTC DRUG LABEL	8