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 225 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vertra Ehukai Beige Sunscreen Face Stick Broad Spectrum SPF 38	TITANIUM DIOXIDE	Eai-jr 286, Inc	303d5d5a-4c7a-1e23-e063-6294a90a0e58	2025-03-13	Warnings	Exact identifier application number: M020
belif Dew guard - daily mineral sunscreen Broad Spectrum SPF 50	ZINC OXIDE	LG H&H CO., LTD.	2b4c363b-f767-7901-e063-6394a90adba5	2025-03-13	Warnings	Exact identifier application number: M020
Zinc Oxide	MINERAL SUNSHIELD UNIVERSAL TINT BROAD SPECTRUM SPF 30 SUNSCREEN	Vege Labs LLC	303e84e1-3bea-ea6f-e063-6294a90aeaa7	2025-03-13	Warnings	Exact identifier application number: M020
MURASAKI BEAUTY Silicence Scar Gel SPF 30	ZINC OXIDE, ETHYLHEXYL METHOXYCINNAMATE	Haikou Pucao Trading Co.,Ltd	303f7dd6-aef2-30ce-e063-6394a90ac00f	2025-03-13	Warnings	Exact identifier application number: M020
SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 110	OCTINOXATE	SHISEIDO AMERICAS CORPORATION	393ce1fa-f188-45d0-a23e-2818de974995	2025-03-13	Warnings	Exact identifier application number: M020
SHISEIDO FUTURE solution LX TOTAL PROTECTIVE S	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	SHISEIDO AMERICAS CORPORATION	1a304bf0-dcda-4887-9738-54ce35ca503b	2025-03-13	Warnings	Exact identifier application number: M020
SHISEIDO REVITALESSENCE SKIN GLOW PRIMER	AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE	SHISEIDO AMERICAS CORPORATION	805fd75e-3c53-4ddd-afdc-a65f921822d4	2025-03-13	Warnings	Exact identifier application number: M020
Visor Clear Body Oil-Free Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	VISOR SKINCARE LLC	10abc330-7d45-4049-b80a-dbf58374187e	2025-03-12	Warnings	Exact identifier application number: M020
Visor Clear Face Oil-Free Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	VISOR SKINCARE LLC	462acd16-b9c0-4f02-b297-d9b54036b531	2025-03-12	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	HOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONE	Edgewell Personal Care Brands LLC	302982a3-e3f9-ef46-e063-6394a90abaf8	2025-03-12	Warnings	Exact identifier application number: M020
Neutrogena Pure And Free Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	Kenvue Brands LLC	41ff1a98-69ff-4d7a-bc89-d986a803cee3	2025-03-10	Warnings	Exact identifier application number: M020
Sheer Mineral Antioxidant Sunscreen SPF50	ZINC OXIDE	Topiderm, Inc.	1af53e89-debe-4f4c-b0ef-eec2073228df	2025-03-07	Warnings	Exact identifier application number: M020
COOLA Firming Face Serum Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SUNSCREEN SERUM	COOLA LLC	85fd7ef4-ed08-4a69-8293-5f3f3d264c04	2025-03-06	Warnings	Exact identifier application number: M020
GOLDEN HOUR HYDRATING SPF 30	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Dermalogica, LLC.	090b5861-20f5-43c6-aff6-d17d61e8568e	2025-03-04	Warnings	Exact identifier application number: M020
Aveeno Baby continuous protection sensitive skin Sunscreen Broad Spectrum SPF50	ZINC OXIDE	Kenvue Brands LLC	bbd6710f-a665-437e-b86b-437f732984d1	2025-03-04	Warnings	Exact identifier application number: M020
LBEL DIVINE DOUBLE USE LONGWEAR 36H SPF 15 CREME 110	OCTINOXATE, ZINC OXIDE	BELSTAR S.A.	2f8607c5-b5ab-ed81-e063-6394a90a3453	2025-03-04	Warnings	Exact identifier application number: M020
ADVANCED PROTECTION SUNSCREEN SPF-30	OCTINOXATE, OCTISALATE, ZINC OXIDE	BOTANICAL SCIENCE, INC.	2f8bbd08-d199-03bd-e063-6294a90adfac	2025-03-04	Warnings	Exact identifier application number: M020
MINERAL TINTED SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	BOTANICAL SCIENCE, INC.	2f9e2252-fb54-363f-e063-6294a90aa7c9	2025-03-04	Warnings	Exact identifier application number: M020
LBEL LUMI-AGE ANTI-AGING HYDRATING DAY FACIAL SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	BEL STAR S.A.	2f717492-347d-5bf8-e063-6294a90a4b5f	2025-03-03	Warnings	Exact identifier application number: M020
CoTZ Kids Mineral Sun Stick	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	2f7225d0-ddfa-e19a-e063-6294a90a52a8	2025-03-03	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