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_7af0f836-c146-4bbf-b8e6-40e25f9a9723
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 46783-002 | 46783-002-50 | D | Discontinued by firm | 2026-10-15 |
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.
| 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 |
|---|---|
| OCTINOXATE | 75 mg/mL |
| ZINC OXIDE | 73 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4Y5P7MUD51 | Internal UNII lookup |
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e120a659-0dfc-42ca-8158-58e8a0b457e5 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | 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 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Sunscreen SPF 50 | SUNSCREEN SPF 50 | Guangzhou Ariel Biotech Co., Ltd. | 14b9ec0e-6fff-44b1-e063-6394a90aab97 | 2026-03-05 | Warnings | M020 |
| belif Aqua bomb - glow sunstick SPF50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | LG H&H CO., LTD. | 4c35fbbc-a79d-318f-e063-6394a90a30a7 | 2026-03-04 | Warnings | M020 |
| Kids Mineral Sunscreen Stick SPF 50 | ZINC OXIDE | Smalls Brand LLC DBA Roe Wellness | 4c37855b-08c0-0aa7-e063-6394a90a8842 | 2026-03-04 | Warnings | M020 |
| La Roche Posay Laboratoire Dermatologique Toleriane Double Repair Moisturizer UV Broad Spectrum SPF 30 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE | LOreal USA Products Inc | be03b588-afbd-41d1-be96-444d735c9768 | 2026-03-03 | Warnings | M020 |
| UNME SOULMA CENTELLA and BEEF TALLOW SUNSCREEN | ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE, ZINC OXIDE, PHENYLBENZIMIDAZOLE SULFONIC ACID | Shenzhen Jufeng Qiyuan Trading Co., Ltd. | 4c1a3345-58c1-93c8-e063-6394a90a865e | 2026-03-03 | Warnings | M020 |
| Botnia Gentle Sun SPF 30 | ZINC OXIDE | Botnia, Inc | 005d0245-fe53-47e5-888b-683f58cd6d26 | 2026-03-03 | Warnings | M020 |
| Broad Spectrum Sunscreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | 64534ec3-396c-4c11-9ec1-e2615f7e24b1 | 2026-03-03 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | 9b7249e4-4c1f-40e7-a657-d40c53d9317f | 2026-03-03 | Warnings, Adverse reactions | M020 |
| Sunscreen | SUNSCREEN | Old East Main Co. | 1673b8b1-08ad-40a5-8180-93333a8edb67 | 2026-03-03 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | 32036e41-2414-4498-8e1c-61511abf7a32 | 2026-03-03 | Warnings, Adverse reactions | M020 |
| Sport Sunscreen SPF 100 | AVOBENZONE HOMOSALATE OCTISALATE | Old East Main Co. | 42266fa5-5f30-2a9f-e063-6394a90a1dfe | 2026-03-03 | Warnings, Adverse reactions | M020 |
| Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Amazon.com Services LLC | d4b4ebac-c6c2-474b-afc6-b80b8431e90f | 2026-03-03 | Warnings, Adverse reactions | M020 |
| Fruit Snack SPF 15 Broad Spectrum Lip Balm | FRUIT SNACK SPF 15 BROAD SPECTRUM LIP BALM | Raining Rose, Inc | 24c2a9fc-892b-c74d-e063-6394a90af62c | 2026-03-03 | Warnings | M020 |
| Olay Complete plus Principle Invisible Facial Primer plus Sunscreen Broad Spectrum SPF 35 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | The Procter & Gamble Manufacturing Company | 4c231aa1-75eb-c171-e063-6294a90a8b8b | 2026-03-03 | Warnings | M020 |
| SPF 30 Mineral Sunscreen | ZINC OXIDE | Smalls Brand LLC DBA Roe Wellness | 4c25b4ec-b045-7066-e063-6294a90ab801 | 2026-03-03 | Warnings | M020 |
| Good Weather Skin Daily Lip Sun Gloss SPF 30 Iced Coffee | ZINC OXIDE | Good Weather Inc. | 4c261e88-7f37-2361-e063-6294a90aa602 | 2026-03-03 | Warnings | M020 |
| Good Weather Skin All Over Sun Milk Face and Body SPF 50 | ZINC OXIDE | Good Weather Inc. | 4c278acc-7cd5-0d85-e063-6394a90a3a72 | 2026-03-03 | Warnings | M020 |
| Lekura - ZincDaily Natural Face Sunscreen SPF50 | ZINC OXIDE SUNSCREEN | VEGANIC SKN LIMITED | 4c2bed23-f77b-2c97-e063-6394a90a4ca5 | 2026-03-03 | Warnings | M020 |
| NEOGEN DERMALOGY DAY-LIGHT PROTECTION AIRY SUNSCREEN BROAD SPECTRUM SPF 50 | AVOBENZONE, HOMOSALATE, OCTOCRYLENE | OUTIN FUTURES CO.,LTD. | 4ddce1f0-44a3-7e0c-e063-6294a90a3f7d | 2026-03-03 | Warnings | M020 |
| Bephor Reviving Suncream SPF50 | ETHYLHEXYL METHOXYCINNAMATE, HOMOSALATE, ZINC OXIDE | Gyeongbuk Institute of IT Convergence Industry Technology | 4c055b22-94e9-ff0d-e063-6394a90ab2ec | 2026-03-02 | Warnings | M020 |
Packages#
| 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 |