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 216 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Algenist	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Solazyme, Inc.	4ece1847-1c94-4bf7-b936-109556a460a7	2025-04-22	Warnings	Exact identifier application number: M020
Sulwhasoo Perfecting Cushion NO.17N1 Vanilla	OCTINOXATE, TITANIUM DIOXIDE, AND HOMOSALATE	Amorepacific Corporation	3350f28e-22b4-904c-e063-6394a90a1c81	2025-04-21	Warnings	Exact identifier application number: M020
Neutrogena Sheer Zinc Kids Mineral Sunscreen Broad Spectrum SPF 50 Plus	ZINC OXIDE	Kenvue Brands LLC	c914c4cd-99a2-4d9f-8f04-8af2ace3c345	2025-04-18	Warnings	Exact identifier application number: M020
Charlis Neutral Tinted Face Moisturizer Mineral Sunscreen SPF 25	ZINC OXIDE	CHARLIS LLC	330f7470-0d53-7361-e063-6394a90a5d59	2025-04-18	Warnings	Exact identifier application number: M020
Chardonnay Lip Oil	AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE	Vacation Inc	1318a429-d382-f5b8-e063-6394a90a3bd4	2025-04-18	Warnings	Exact identifier application number: M020
Shimmer Oil	AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE	Vacation Inc.	131c63ba-57fc-9ce8-e063-6294a90acd92	2025-04-18	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	055431a6-e9e0-99b4-e063-6394a90acb11	2025-04-17	Warnings	Exact identifier application number: M020
SILKEN pore perfecting sunscreen broad spectrum SPF 35	OCTISALATE, ZINC OXIDE	TATCHA INC.	251566a1-0e21-4030-9d4e-52c4a8bd3330	2025-04-16	Warnings	Exact identifier application number: M020
Dermatone SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Dermatone Labs LLC	32e5bddf-a0b5-c511-e063-6294a90aaf66	2025-04-16	Warnings	Exact identifier application number: M020
Sunscreen Lip Balm SPF 30 Cool Mint	AVOBENZONE 3%, HOMOSALATE 7%, OCTISALATE 4.5%, OCTOCRYLENE 9%	USRX	3271ab14-3bf5-a24f-e063-6294a90a59bc	2025-04-16	Warnings	Exact identifier application number: M020
goodal GREEN TANGERINE VITA C DARK SPOT UV DEFENSE SUNSCREEN SPF50	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	CLIO COSMETICS Co., Ltd.	77a0d190-f558-474b-89d2-c79b37c50c0d	2025-04-16	Warnings	Exact identifier application number: M020
Brush On Block SPF 30 Mineral Powder Touch of Tan Zinc Only - REFILL	ZINC OXIDE	SPF Ventures, LLC	32ccb93a-50cf-f436-e063-6294a90a2492	2025-04-15	Warnings	Exact identifier application number: M020
DECORTE SUN SHELTER MULTI PROTECTION Sunscreen SPF 50 Broad Spectrum	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE	KOS America, Inc.	2b41c17d-1394-0c2f-e063-6394a90a0c49	2025-04-15	Warnings	Exact identifier application number: M020
Urban Antioxidant Sunscreen SPF 40	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXYIDE CREAM	Dr. Loretta, LLC	930150a3-08bb-17fd-e053-2995a90a786b	2025-04-15	Warnings	Exact identifier application number: M020
Cicapair Soothing Color Correcting Treatment Cica Complex Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	Have & Be Co., Ltd.	32c1aba6-5e29-aba9-e063-6394a90a8e56	2025-04-14	Warnings	Exact identifier application number: M020
REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY	OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE	CLINIQUE LABORATORIES LLC	07701e11-8a7e-44c5-b46e-5b48264eacad	2025-04-14	Warnings	Exact identifier application number: M020
Dr.Ceuracle HYDRA BARRIER SUNSCREEN	ZINC OXIDE	Leegeehaam Cosmetics	22c05215-4983-b32e-e063-6394a90a9f67	2025-04-13	Warnings	Exact identifier application number: M020
No7 Protect and Perfect Intense Advanced Day Cream SPF 30	AVOBENZONE,OCTISALATE, OCTOCRYLENE	BCM Cosmetique SAS	3285e28d-5716-b576-e063-6294a90a8905	2025-04-11	Warnings	Exact identifier application number: M020
No7 Protect and Perfect Intense Advanced Fragrance Free Day Cream SPF 30	AVOBENZONE,OCTISALATE, OCTOCRYLENE	BCM Cosmetique SAS	32876315-f81f-fdd2-e063-6394a90ad5f7	2025-04-11	Warnings	Exact identifier application number: M020
No7 Future Renew Damage Reversal Day Cream Sunscreen Broad Spectrum SPF 25	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	BCM Cosmetique SAS	3287ae2e-759e-31c5-e063-6394a90a892f	2025-04-11	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