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	2026-10-30
excluded package	package	46783-002	46783-002-03	D	Discontinued by firm	2026-10-30
excluded package	package	46783-002	46783-002-05	D	Discontinued by firm	2026-10-30
excluded package	package	46783-002	46783-002-50	D	Discontinued by firm	2026-10-30

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 252 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06c61c42-edc9-1ebd-e063-6294a90aee13	2024-12-25	Warnings	Exact identifier application number: M020
Invisible Sunscreen SPF 40	HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE	COSMAX USA, CORPORATION	29fe531e-2ade-170f-e063-6394a90a1396	2024-12-24	Warnings	Exact identifier application number: M020
SOLAR MILK SPF50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	29fe4dad-d1fb-e750-e063-6294a90ab307	2024-12-24	Warnings	Exact identifier application number: M020
CHANTECAILLE Ultra Sun Protection Sunscreen Broad Spectrum SPF 45	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Chantecaille Beaute Inc	d30cc344-846d-416e-ac57-4a29d4ed8263	2024-12-24	Warnings	Exact identifier application number: M020
Almay Age Smart Shade CC Luminous Primer SPF 15	ZINC OXIDE, TITANIUM DIOXIDE MAKE-UP	Almay, Inc.	281557c0-e668-4436-86a7-3f583091e4e4	2024-12-24	Warnings	Exact identifier application number: M020
EIGHT HOUR LIP PROTECTANT SPF 15	PETROLATUM, OXYBENZONE, OCTINOXATE, AVOBENZONE	REVLON	2a0ac6aa-0315-d79e-e063-6294a90a9c53	2024-12-24	Warnings	Exact identifier application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Amber	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b311f-9dcc-9b26-e063-6394a90a29a8	2024-12-24	Warnings	Exact identifier application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Buff Beige	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b3b8b-d38b-cd4d-e063-6294a90a919a	2024-12-24	Warnings	Exact identifier application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Hazel	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b3b8b-d38c-cd4d-e063-6294a90a919a	2024-12-24	Warnings	Exact identifier application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Cool Beige	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b48b8-5953-9ab7-e063-6394a90a6b24	2024-12-24	Warnings	Exact identifier application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Creamy Natural	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b311f-9dcd-9b26-e063-6394a90a29a8	2024-12-24	Warnings	Exact identifier application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Rich Mahogany	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b6b99-883b-ffd4-e063-6294a90a7f4b	2024-12-24	Warnings	Exact identifier application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Light Tan	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b557a-ff60-f33f-e063-6394a90ac66f	2024-12-24	Warnings	Exact identifier application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Light Beige	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b6b99-8839-ffd4-e063-6294a90a7f4b	2024-12-24	Warnings	Exact identifier application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Light Natural	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b668d-036e-893e-e063-6294a90a82af	2024-12-24	Warnings	Exact identifier application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Rich Sand	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b6ba3-b5da-f2f7-e063-6394a90a86ae	2024-12-24	Warnings	Exact identifier application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Soft Nutmeg	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b856a-d714-892c-e063-6294a90a4ae9	2024-12-24	Warnings	Exact identifier application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Sandalwood	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b856a-d712-892c-e063-6294a90a4ae9	2024-12-24	Warnings	Exact identifier application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Tan Sand	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b5cca-4e4f-efb6-e063-6294a90a6206	2024-12-24	Warnings	Exact identifier application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Warm Caramel	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b9147-3c7a-d549-e063-6394a90a6869	2024-12-24	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