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 84 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
(Re) Setting 100% mineral Powder Light Broad Spectrum SPF 35	ZINC OXIDE	Supergoop, LLC	aed5a7ef-5cf2-6738-e053-2a95a90aa7f7	2026-01-09	Warnings	Exact identifier application number: M020
Play Mineral Broad Spectrum SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Supergoop, LLC	89088ac5-f1ee-1996-e053-2a95a90a8fdc	2026-01-09	Warnings	Exact identifier application number: M020
(RE) Setting 100% Mineral Powder Medium Broad Spectrum Sunscreen SPF 35	ZINC OXIDE	Supergoop, LLC	af4b0f17-43ec-a176-e053-2a95a90a7ac6	2026-01-09	Warnings	Exact identifier application number: M020
(Re) Setting 100% mineral Powder Deep Broad Spectrum SPF 35	ZINC OXIDE	Supergoop, LLC	af4cb85b-1275-2105-e053-2995a90a7e74	2026-01-09	Warnings	Exact identifier application number: M020
Play Lip Balm with Acai Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	9f5b54c7-a424-6917-e053-2a95a90ac627	2026-01-09	Warnings	Exact identifier application number: M020
Everyday Sunscreen with Sunflower Extract Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	Supergoop, LLC	81b9fda2-bd55-1b90-e053-2991aa0a765a	2026-01-09	Warnings	Exact identifier application number: M020
Play Lip Balm Broad Spectrum SPF 30 with Mint	AVOBENZONE, HOMOSALATE, OCTISALATE,	Supergoop, LLC	9f6cd243-ef5c-df8a-e053-2a95a90a4e36	2026-01-09	Warnings	Exact identifier application number: M020
Poolside Sun Silk Body Sunglow 05 Fragrance SPF 30 Sunscreen Body	HOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONE	I World LLC	4416ad39-a4b5-4238-9792-c7f475d1e561	2026-01-09	Warnings	Exact identifier application number: M020
Lip Screen Broad Spectrum SPF 40	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	a3e5819a-5132-9760-e053-2a95a90a058b	2026-01-09	Warnings	Exact identifier application number: M020
Poolside Orange Creme SPF 30 Scented Sunscreen	HOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONE	I World LLC	d96a1390-27be-452a-818b-0ba6127e9f96	2026-01-09	Warnings	Exact identifier application number: M020
Sugargirl Glowy SPF 30 Face Screen Daybreak Shimmer Sunscreen For the Face	HOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONE	I World LLC	4554d9a8-33a1-4299-8a57-dab72980b2eb	2026-01-09	Warnings	Exact identifier application number: M020
Sugargirl Glowy SPF 30 Face Screen Solar Shimmer Sunscreen For the Face	HOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONE	I World LLC	b5be8ea7-3408-4495-9a50-3328f7698738	2026-01-09	Warnings	Exact identifier application number: M020
Sugargirl Glowy SPF 30 Face Screen Sunlight Shimmer Sunscreen For the Face	HOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONE	I World LLC	c99464d1-a5bb-4140-a95e-25d6b383616c	2026-01-09	Warnings	Exact identifier application number: M020
Sugargirl Set Screen SPF 30 Setting Powder Sunscreen Light	ZINC OXIDE, TITANIUM DIOXIDE	I World LLC	1fabd546-55e5-4ab2-8a1b-7b161bfbb866	2026-01-09	Warnings	Exact identifier application number: M020
Sugargirl Set Screen SPF 30 Setting Sunscreen Medium	ZINC OXIDE, TITANIUM DIOXIDE	I World LLC	876a6f88-8dac-4303-8acb-525999c93528	2026-01-09	Warnings	Exact identifier application number: M020
Sugargirl Glowy Face Screen Sunbeam Shimmer Sunscreen For the Face SPF 30	HOMOSALATE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, AVOBENZONE	I World LLC	f6316c4f-076a-4ba5-a526-0e20e5156ced	2026-01-09	Warnings	Exact identifier application number: M020
Sugargirl Set Screen SPF 30 Setting Sunscreen Translucent	ZINC OXIDE, TITANIUM DIOXIDE	I World LLC	0a3bae73-141b-4a47-be35-c5708dfb1180	2026-01-09	Warnings	Exact identifier application number: M020
Artistry Exact Fit Longwearing Foundation Shade Sand L2W1	TITANIUM DIOXIDE	Amway Corp	4345cdf6-e220-4e7c-8abd-da59d2b7db84	2026-01-09	Warnings	Exact identifier application number: M020
Mineral Sheer Screen Broad Spectrum Sunscreen SPF 30	ZINC OXIDE	Supergoop LLC	b47ed3bf-92a8-9bc9-e053-2a95a90a8eee	2026-01-09	Warnings	Exact identifier application number: M020
Daily Dose Hydra-Ceramide Boost Broad Spectrum Sunscreen SPF 40	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	ca5520a1-4c43-cb32-e053-2a95a90a97f5	2026-01-09	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.	2026-05-20	HUMAN OTC DRUG LABEL	8