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	2026-10-28
excluded package	package	46783-002	46783-002-03	D	Discontinued by firm	2026-10-28
excluded package	package	46783-002	46783-002-05	D	Discontinued by firm	2026-10-28
excluded package	package	46783-002	46783-002-50	D	Discontinued by firm	2026-10-28

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 246 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Badger SPF 30 Daily Sunscreen	ZINC OXIDE	W.S. Badger Company, Inc.	11e65bae-2361-5440-e063-6294a90a075e	2024-12-31	Warnings	Exact identifier application number: M020
Advanced Ceramide Lift and Firm Day Cream Broad Spectrum Sunscreen SPF 15	OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE	REVLON	d09ab4ca-6d5c-47bd-e053-2a95a90a409d	2024-12-31	Warnings	Exact identifier application number: M020
Almay Healthy Biome Makeup Fair	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Almay	2a947e1d-286f-a939-e063-6394a90a0719	2024-12-31	Warnings	Exact identifier application number: M020
Almay Healthy Biome Makeup Tan	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Almay	2a94a668-24cb-e0f2-e063-6294a90a79d3	2024-12-31	Warnings	Exact identifier application number: M020
Almay Healthy Biome Makeup Medium	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Almay	2a94c0a2-8a47-39b9-e063-6394a90acf8c	2024-12-31	Warnings	Exact identifier application number: M020
ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20	TITANIUM DIOXIDE, ZINC OXIDE	Almay, Inc.	2a962944-9155-9b70-e063-6294a90ac535	2024-12-31	Warnings	Exact identifier application number: M020
ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20 Medium	TITANIUM DIOXIDE, ZINC OXIDE	Almay, Inc.	2a96811c-3ea6-15bc-e063-6394a90ac3bd	2024-12-31	Warnings	Exact identifier application number: M020
Revlon Colorstay Liquid Makeup for Normal to Dry Skin	ZINC OXIDE, TITANIUM DIOXIDE MAKE-UP	Revlon Consumer Products Corp	414538d6-9108-54bf-e054-00144ff8d46c	2024-12-31	Warnings	Exact identifier application number: M020
Revlon Colorstay Preo and Protect Primer	TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE PRIMER	Revlon Consumer Products Corp	8eebf23e-7fce-dfc0-e053-2995a90ae322	2024-12-31	Warnings	Exact identifier application number: M020
Revlon Kiss Balm SPF 20	AVOBENZONE, BENZOPHENONE-3, OCTINOXATE	Revlon Consumer Products Corp	410d1cb2-6c90-1ca3-e054-00144ff8d46c	2024-12-31	Warnings	Exact identifier application number: M020
Revlon PhotoReady BB Cream Skin Perfector	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE MAKE-UP	Revlon Consumer Products Corp	410ca372-4698-029d-e054-00144ff8d46c	2024-12-31	Warnings	Exact identifier application number: M020
Revlon Colorstay Liquid Makeup for Oily to Combination Skin	ZINC OXIDE, TITANIUM DIOXIDE MAKE-UP	Revlon Consumer Products Corp	410d1cb2-6c92-1ca3-e054-00144ff8d46c	2024-12-31	Warnings	Exact identifier application number: M020
REVLON PHOTOREADY INSTA-FIX MAKEUP	TITANIUM DIOXIDE, ZINC OXIDE	Revlon Consumer Products Corp	442f2a06-47c0-2522-e054-00144ff88e88	2024-12-31	Warnings	Exact identifier application number: M020
Revlon Youth FX	ZINC OXIDE, TITANIUM DIOXIDE MAKE-UP	Revlon Consumer Products Corp	442dec1e-032c-28de-e054-00144ff8d46c	2024-12-31	Warnings	Exact identifier application number: M020
Almay Smart Shade Skintone Matching Makeup Medium	TITANIUM DIOXIDE ZINC OXIDE	Almay, Inc.	2a971e38-af63-e069-e063-6294a90a8f77	2024-12-31	Warnings	Exact identifier application number: M020
REVLON AGE DEFYING FIRMING LIFTING MAKEUP SPF 15	OCTINOXATE, TITANIUM DIOXIDE MAKE-UP	Revlon Consumer Products Corp	d9209277-469d-48f4-bf64-f39a70c19596	2024-12-31	Warnings	Exact identifier application number: M020
Almay Smart Shade Skintone Matching Makeup Light	TITANIUM DIOXIDE ZINC OXIDE	Almay, Inc.	2a987b85-efdb-eb95-e063-6394a90aef81	2024-12-31	Warnings	Exact identifier application number: M020
ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20 Light	TITANIUM DIOXIDE, ZINC OXIDE	Almay, Inc.	2a984dd9-7293-77f0-e063-6294a90a8f1e	2024-12-31	Warnings	Exact identifier application number: M020
Vichy Laboratoires Capital Soleil 50 Daily AntiAging Face Sunscreen Broad Spectrum SPF 50 Water Resistant 80 Minutes	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	LOreal USA Products Inc	097fc15e-ea17-47b2-9581-19c5e11592f6	2024-12-30	Warnings	Exact identifier application number: M020
HERBAL UV DEFENSE SPF40	HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE	COSMAX USA, CORPORATION	2a76fd94-2f1f-e6d8-e063-6294a90a287c	2024-12-30	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