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 139 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sheer Facial Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	BB MEDICAL & DERMATOLOGY INC	342b2403-4f4a-3e77-e063-6294a90a4f0a	2025-12-10		Exact identifier application number: M020
Sheer Mineral Sunscreen Bar	TITANIUM DIOXIDE, ZINC OXIDE	BB MEDICAL & DERMATOLOGY INC	342b69d5-f0e1-99cd-e063-6294a90abb6e	2025-12-10		Exact identifier application number: M020
Sheer Facial Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	BB MEDICAL & DERMATOLOGY INC	342c3f42-c17f-f777-e063-6394a90a8058	2025-12-10		Exact identifier application number: M020
Lip SPF	TITANIUM DIOXIDE, ZINC OXIDE	FRANCISCO FLORES, M.D., P.A.	396d3fdd-99d8-77e8-e063-6294a90aec2f	2025-12-10		Exact identifier application number: M020
Non-Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	FRANCISCO FLORES, M.D., P.A.	396cae82-7641-e1b2-e063-6394a90a7c07	2025-12-10		Exact identifier application number: M020
Solar Knight SPF 40 Broad Spectrum	TITANIUM DIOXIDE, ZINC OXIDE	MASCARENAS ENTERPRISES, INC.	36c27c91-22ac-205c-e063-6294a90ab379	2025-12-10		Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	FRANCISCO FLORES, M.D., P.A.	396ce15a-06ad-4055-e063-6294a90a27fb	2025-12-10		Exact identifier application number: M020
Dermablue Daily Replenishing	ZINC OXIDE	Dermablue, P.C.	308da9c9-544e-d5d1-e063-6294a90aa49b	2025-12-10	Warnings	Exact identifier application number: M020
Recoverie Mineral Matte	ZINC OXIDE	Clear Day Acne Clinic	308f41de-fb14-40f9-e063-6394a90a008f	2025-12-10	Warnings	Exact identifier application number: M020
AL0043600 Alba Botanica VE Herbal Healing Body	COLLOIDAL OATMEAL	The Hain Celestial Group, Inc.	60672feb-141f-651e-e053-2a91aa0af41d	2025-12-10	Warnings	Exact identifier application number: M020
UV Defense me. Matte Airy-Fit Sunscreen	ZINC OXIDE	MAGNIF CO., LTD	459f2b8d-453c-4dee-e063-6394a90a4509	2025-12-10	Warnings	Exact identifier application number: M020
RoC Hydration Plus SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Roc Skincare	45a3e250-8195-344d-e063-6294a90ae681	2025-12-10	Warnings	Exact identifier application number: M020
ROC MULTI CORREXION HYDRATE AND PLUMP DAILY MOISTURISER SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Roc Skincare	bf3c1474-e353-63a5-e053-2a95a90a9b26	2025-12-10	Warnings	Exact identifier application number: M020
ROC MULTI CORREXION EVEN TONE LIFT DAILY MOISTURIZER SPF30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Roc Skincare	f161d754-0c32-2fbe-e053-2a95a90a6b47	2025-12-10	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 35N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	242ff053-b8c0-4f90-e063-6294a90a7bb3	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 13 IVORY	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	247ef1f8-ad12-4f80-e063-6394a90a3e3c	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 13C	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	e810d366-0c32-5b1c-e053-2a95a90a622e	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	242b7d0e-82d8-793c-e063-6294a90a4aa3	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23W	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	eb744367-f318-e1e2-e053-2a95a90a2cc4	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	242faaed-e85a-a1d7-e063-6294a90aea92	2025-12-09	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