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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | 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.
| 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 |
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 |
|---|---|---|---|---|---|---|
| e.l.f. Wake the E.L.F. Up Skincare Set | AVOBENZONE, OCTISALATE, OCTOCRYLENE, HOMOSALATE | e.l.f. Cosmetics, Inc | 4b20c56a-3e91-3419-e063-6294a90ad361 | 2026-02-18 | Warnings | M020 |
| Dermatone Mineral SPF 30 | ZINC OXIDE 20% | Dermatone Labs LLC | 26e3209f-cb5c-484e-9b2e-74dc397d4790 | 2026-02-18 | Warnings | M020 |
| SHISEIDO ESSENTIAL ENERGY HYDRATING DAY | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | SHISEIDO AMERICAS CORPORATION | 8b88039a-09fe-458b-b80f-49cde49b6595 | 2026-02-17 | Warnings | M020 |
| cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED n | AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | f3729d0b-e601-48bb-9907-1d6e3ab31996 | 2026-02-17 | Warnings | M020 |
| Luminesce Daily Moisturizing Complex | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Velovita Inc. | 4b0c2213-8667-be6f-e063-6394a90a5e86 | 2026-02-17 | Warnings | M020 |
| Sport Sunscreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE | Valu Merchandisers Company | e168f8e8-22d0-4a60-b9f9-dec9d0fab3f1 | 2026-02-16 | Warnings, Adverse reactions | M020 |
| Sunscreen for Kids SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE | Valu Merchandisers Company | cfc3b202-6511-450a-b3c1-2d8e8ebc070d | 2026-02-16 | Warnings, Adverse reactions | M020 |
| Sport Sunscreen SPF 70 | AVOBENZONE, HOMOSALATE, OCTISALATE | Valu Merchandisers Company | 5a8af0ea-b31c-456a-bc23-31e2473ca75a | 2026-02-16 | Warnings, Adverse reactions | M020 |
| Sparms 100% Organic Face Sunscreen | ZINC OXIDE SUNSCREEN | VEGANIC SKN LIMITED | 4ae6b187-142b-e4a6-e063-6294a90af365 | 2026-02-15 | Warnings | M020 |
| Lotus Harmony - Quinn Shield Sunscreen SPF50 | ZINC OXIDE SUNSCREEN | VEGANIC SKN LIMITED | 4ae73d23-1118-716c-e063-6394a90a68c7 | 2026-02-15 | Warnings | M020 |
| Avebonzone, Homosalate, Octisalate | AVEBONZONE, HOMOSALATE, OCTISALATE | Amazon.com Services LLC | 4ab542aa-bd05-ba7a-e063-6294a90ae584 | 2026-02-13 | Warnings, Adverse reactions | M020 |
| Beauty Hydrating | HOMOSALATE, ZINC OXIDE | Topco Associates LLC | 6e88ccc8-8576-4573-8a5b-28e64008a349 | 2026-02-13 | Warnings, Adverse reactions | M020 |
| Wotnot Naturals Natural Zinc Sunscreen SPF 30 | ZINC OXIDE | ECOdirect Pty Ltd (Trading as Wotnot Naturals) | 4ab759ae-0c1c-bddc-e063-6394a90a1d09 | 2026-02-13 | Warnings | M020 |
| Wotnot Naturals Natural Zinc Sunscreen SPF 30 | ZINC OXIDE | ECOdirect Pty Ltd (Trading as Wotnot Naturals) | 4ab83b34-9376-d169-e063-6394a90a18cd | 2026-02-13 | Warnings | M020 |
| Homosalate, Octisalate, Zinc oxide | HOMOSALATE, OCTISALATE, ZINC OXIDE | Topco Associates LLC | 48fb9a3c-c058-ce71-e063-6294a90aaf1e | 2026-02-13 | Warnings, Adverse reactions | M020 |
| Ambi Even and Clear Facial Moisturizer | HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 3%, AVOBENZONE 3% | 73453-112 | 469440e9-bf47-bebd-e063-6294a90acca2 | 2026-02-12 | Warnings | M020 |
| Intelligent Defense Mineral Sunscreen | ZINC OXIDE | GLO PHARMA | 4ab664aa-5f0c-7ddb-e063-6294a90a9753 | 2026-02-12 | Warnings | M020 |
| Sky and Sol Sports Sunscreen | ZINC OXIDE | Delta Ecommerce LLC | 4dd054cd-8f53-4210-e063-6394a90ade27 | 2026-02-12 | Warnings | M020 |
| Sky and Sol Kids and Babies Sunscreen | ZINC OXIDE | Delta Ecommerce LLC | 4de67653-ab31-c6b2-e063-6394a90a7e8c | 2026-02-12 | Warnings | M020 |
| Eva Claire Natural Professional Sunscreen | AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE | Eva Claire Cosmetics Co., Ltd. | 4a870452-cac2-4d2c-e063-6294a90abb07 | 2026-02-11 | 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 |