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	2026-10-23
excluded package	package	46783-002	46783-002-03	D	Discontinued by firm	2026-10-23
excluded package	package	46783-002	46783-002-05	D	Discontinued by firm	2026-10-23
excluded package	package	46783-002	46783-002-50	D	Discontinued by firm	2026-10-23

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 205 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
KLARINA Sheer Mineral Sunscreen Blender SPF 50	ZINC OXIDE	KLARINA INC	081941e3-02da-43a2-bf6f-a6d0f053272f	2025-07-10	Warnings	Exact identifier application number: M020
ATHLETIC COSMETIC COMPANY Clear Power Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	ATHLETIC COSMETIC COMPANY LLC	f143a8e0-b32b-4b14-a6ae-f013627b484c	2025-07-10	Warnings	Exact identifier application number: M020
Venofye Orchard Bee Brilliance SPF 30	OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE	Innovation Brands Inc.	7c36c7e5-bc0b-40e6-bdbc-fd34f0b0eafe	2025-07-10	Warnings	Exact identifier application number: M020
Touch Anti-Aging SPF 30 Moisturizer	ZINC OXIDE, OCTINOXATE, AND OCTISALATE	Diractions Capital LLC	47ce948e-5848-43a1-880e-aeb78e9ad1b3	2025-07-10	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 60 Breakout Free Oil Free Face Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	06f2ced8-273e-454f-92b4-2846f6674b37	2025-07-10	Warnings	Exact identifier application number: M020
SPF30 unseen sunscreen 01	BUTYL METHOXYDIBENZOYLMETH, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	398bb1f5-80ea-c589-e063-6294a90abefd	2025-07-09	Warnings	Exact identifier application number: M020
Prada Reveal Skin Optimizing Foundation Broad Spectrum SPF 17 Sunscreen	ENSULIZOLE	SICOS ET CIE	1ac50772-0bea-4a41-8300-03f65f0bed52	2025-07-09	Warnings	Exact identifier application number: M020
Prada Reveal Skin Optimizing Foundation Broad Spectrum SPF 17 Sunscreen	ENSULIZOLE	L'Oreal USA Products Inc	e74a8c43-ec70-4de1-b2b5-0e89e40bfb40	2025-07-08	Warnings	Exact identifier application number: M020
IT COSMETICS HELLO SUNSHINE INVISIBLE HYDRATING SERUM BROAD SPECTRUM SPF 50 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	L'Oreal USA Products Inc.	84fbbb01-bb16-41a6-a53a-6e85d515ca2c	2025-07-08	Warnings	Exact identifier application number: M020
CeraVe Developed with Dermatologists Hydrating Sheer Sunscreen Broad Spectrum SPF 30 Face and Body Water Resistant 80 Minutes Hybrid Formula	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE	L'Oreal USA Products, Inc.	cd69df67-5231-4a75-a9fb-a8669806a892	2025-07-08	Warnings	Exact identifier application number: M020
Neutrogena Beach Defense Kids Sunscreen SPF 60 Plus	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kenvue Brands LLC	fea50c84-0567-8547-e053-6394a90aafb7	2025-07-07	Warnings	Exact identifier application number: M020
24K Skin Tone Moisturizer SPF 30	OCTINOXATE, HOMOSALATE, OCTISILATE, OXYBENZONE AND AVOBENZONE	Innovation Brands Inc.	b4f37f69-c61d-40c6-86cc-95d041b4d1b5	2025-07-07	Warnings	Exact identifier application number: M020
Vine Vera Resveratrol Cabernet Replenishing Moisture	OCTINOXATE, HOMOSALATE, OCTISILATE, OXYBENZONE AND AVOBENZONE	Innovation Brands Inc.	c48a7346-3971-4946-b527-a5549a98e246	2025-07-07	Warnings	Exact identifier application number: M020
Lavelier Divine Day Defense Broad Spectrum SPF 30	OCTINOXATE, HOMOSALATE, OCTISILATE, OXYBENZONE AND AVOBENZONE	Innovation Brands Inc.	1f33a93f-ae3f-4024-9d23-26b01eed1764	2025-07-03	Warnings	Exact identifier application number: M020
HIGHHEAT Sunscreen SPF 50 Performance For Athletes	AVOBENZONE, OCTISALATE, OCTOCRYLENE	DUGOUT ESSENTIALS LLC	3b7cddb5-00d2-4998-8eec-5e5a7c5a6097	2025-07-03	Warnings	Exact identifier application number: M020
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	CAPE COD SKIN CARE CO. INC.	39093b2d-3fbb-8378-e063-6294a90ac6d8	2025-07-03		Exact identifier application number: M020
Neutrogena Clear Face Serum Sunscreen Broad Spectrum SPF 60	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kenvue Brands LLC	09ccb37b-78ee-b510-e063-6294a90a48d5	2025-07-01	Warnings	Exact identifier application number: M020
First Aid Beauty FAB Ultra Light Mineral Sunscreen Broad Spectrum SPF 30	ZINC OXIDE	Port Jervis Laboratories, Inc.	4b442fdf-a9cf-7e5a-e063-6394a90a9e1e	2025-07-01	Warnings	Exact identifier application number: M020
Sincerely Yours Sunny Side Up Mineral Sunscreen Broad Spectrum SPF 30	ZINC OXIDE	Sincerely Yours Inc.	4c9dfa22-70f7-83f6-e063-6394a90aa8c5	2025-07-01	Warnings	Exact identifier application number: M020
Nova Bright Skin SPF 30	OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE	Innovation Brands Inc.	1c201147-7a54-41b5-bdf0-394e3d7efc0c	2025-07-01	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