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 |
|---|---|---|---|---|---|---|
| Broad Spectrum Sunscreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE | Meijer, Inc. | c76f5639-bd0f-4987-8c70-224ee33bbbad | 2026-02-24 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Meijer, Inc. | 8795b9a7-1938-4dd9-92ad-3c044feae1da | 2026-02-24 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Meijer, Inc. | 3f8bad95-8071-47b1-88a7-3a3f09f097b5 | 2026-02-24 | Warnings, Adverse reactions | M020 |
| UV RESTORE FACE SERUM SUNSCREEN SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE | BETTER INNOVATION LTD | 4b9a881a-835b-ef0c-e063-6394a90a94af | 2026-02-24 | Warnings | M020 |
| MISTINE UV DEFENSE FACE MOISTURIZER SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | BETTER INVENTION LTD | 4b9a9303-662f-9614-e063-6294a90a6b51 | 2026-02-24 | Warnings | M020 |
| SANTAL BLOOM SUNSCREEN BODY BROAD SPECTRUM SPF 50 | SUNSCREEN | Saltair Body LLC | 4b9ac780-ef7d-42fc-e063-6394a90ad62f | 2026-02-24 | Warnings | M020 |
| PINK BEACH SUNSCREEN BODY BROAD SPECTRUM SPF 50 | SUNSCREEN | Saltair Body LLC | 4b9b36a6-4da9-8439-e063-6394a90aa86b | 2026-02-24 | Warnings | M020 |
| SHISEIDO URBAN ENVIRONMENT MINERAL CLEAR SUNSCREEN | TITANIUM DIOXIDE, ZINC OXIDE | Shiseido Americas Corporation | b93f10dc-193d-4cda-94b6-3f0e54d89f21 | 2026-02-23 | Warnings | M020 |
| cle de peau BEAUTE ADVANCED PROTECTIVE DAY | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Shiseido Americas Corporation | 710975d8-43bf-40b9-82c2-d4dc2988956d | 2026-02-23 | Warnings | M020 |
| SHISEIDO ULTIMATE SUN PROTECTOR MINERAL | TITANIUM DIOXIDE AND ZINC OXIDE | SHISEIDO AMERICAS CORPORATION | 5e31eee8-6532-47ea-99fc-22418791804b | 2026-02-23 | Warnings | M020 |
| Eryfotona Ageless | ZINC OXIDE | ISDIN Corp. | a58ac2ed-31b7-4a86-83ca-7630b0c9ea6f | 2026-02-23 | Warnings | M020 |
| Perfect Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | SKIN PERFECT MEDICAL | 4b47e7cb-17d6-6a7c-e063-6294a90abbea | 2026-02-20 | Warnings | M020 |
| Beauty Hydrating | HOMOSALATE, ZINC OXIDE | Meijer, Inc. | 69b72139-757f-476d-99d2-33f5524c41d2 | 2026-02-19 | Warnings, Adverse reactions | M020 |
| daily moisturizer | AVBENZONE, OCTISALATE, OCTOCRYLENE | Meijer, Inc. | 6d301146-46e0-445c-b14e-3ec8ce76cb45 | 2026-02-19 | Warnings, Adverse reactions | M020 |
| Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Meijer, Inc. | e9f4a2bb-d21e-4b38-9a37-23c23c8ad857 | 2026-02-19 | Warnings, Adverse reactions | M020 |
| Inkeeze Tattoo Products Hi-Definition Tattoo Sunscreen SPF 50 Coconut Scent | AVOBENZONE, OCTISALATE, OCTOCRYLENE | Ink-eeze | 3f759bec-4e33-46fa-a800-fa3a17d63df9 | 2026-02-19 | Warnings | M020 |
| Allay Skin Solutions Protect Nourish Mineral Sunscreen SPF 42 | TITANIUM DIOXIDE, ZINC OXIDE | ALLAY SKIN SOLUTIONS LLC | 425bf1d7-f2cf-4237-9047-dd53054acd1c | 2026-02-18 | Warnings | M020 |
| e.l.f. Best and Obsessed Skincare Set | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 4b1c1150-5ac5-4a8b-e063-6394a90a5410 | 2026-02-18 | Warnings | M020 |
| Hermes Plein Air-Baume de Teint Perfecteur Naturel-Enhancing Complexion Balm 85 TAMARIN | TITANIUM DIOXIDE | S.A. COMPTOIR NOUVEAU DE LA PARFUMERIE | dacff3dc-49d7-6416-e053-2a95a90a85c6 | 2026-02-18 | Warnings | M020 |
| Degree Clinical | COOL RUSH INVISIBLE SOLID 96H ANTIPERSPIRANT DEODORANT | Conopco Inc. d/b/a/ Unilever | 4b1f9fd3-3c49-9a98-e063-6294a90a20e0 | 2026-02-18 | 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 |