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 | 2026-10-23 | |
| excluded package | package | 46783-002 | 46783-002-03 | D | Discontinued by firm | 2026-10-23 | |
| excluded package | package | 46783-002 | 46783-002-05 | D | Discontinued by firm | 2026-10-23 | |
| excluded package | package | 46783-002 | 46783-002-50 | D | Discontinued by firm | 2026-10-23 |
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 |
|---|---|---|---|---|---|---|
| Environ Skin Care RAD Shield Mineral Sunscreen SPF 30 | SUNSCREEN | ENVIRON SKIN CARE (PTY) LTD | 3778547e-11a8-3b30-e063-6394a90ab5b1 | 2025-06-13 | Warnings | M020 |
| Voupre Age Defense | OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE | Innovation Brands Inc. | 8dfaa076-c62a-47ee-bc5d-75360416fa1a | 2025-06-13 | Warnings | M020 |
| Instantly Dry | TITANIUM DIOXIDE, ZINC OXIDE | CLEAN BEAUTY BY ANAK LLC | 37624bf6-4949-1b10-e063-6294a90ac488 | 2025-06-12 | M020 | |
| silk SPF facial sunscreen fluid hybrid broad spectrum SPF 30 UVA/UVB | ZINC OXIDE AND HOMOSALATE | OneKind.25 | d739bc43-d76e-9258-e053-2a95a90a3d2c | 2025-06-12 | Warnings | M020 |
| ULTRA SHEER DAILY DEFENSE FACIAL SPF 18 | HOMOSALATE, OCTISALATE, AND AVOBENZONE | Andalou naturals | 0f7c6d3a-73ea-44d8-a8b9-6a6f1bb02c6f | 2025-06-11 | Warnings | M020 |
| Hydrating Sheer Lip Balm Trio The Vivids Broad Spectrum SPF 30 | AVOBENZONE, OCTISALATE, AND HOMOSALATE | MDSolarSciences | 374e770f-75b5-08d0-e063-6394a90adf92 | 2025-06-11 | Warnings | M020 |
| Reflecting Mineral Sunscreen | ZINC OXIDE, TITANIUM DIOXIDE | Helande, LLC | 3750f04b-7f9f-8793-e063-6294a90a9143 | 2025-06-11 | Warnings | M020 |
| Vitamin C BB Beauty Balm Sheer Tint SFP 30 | ZINC OXIDE | Andalou naturals | f423b484-2119-4c95-a0da-77bcd07303eb | 2025-06-11 | Warnings | M020 |
| Perfecting BB Beauty Balm Natural Tint SPF 30 | ZINC OXIDE | Andalou naturals | 16ca3790-9973-4a04-a43c-e0f7b384f147 | 2025-06-11 | Warnings | M020 |
| SOME BY MI V10 HYAL LIP SUN PROTECTOR | AVOBENZONE, HOMOSALATE, OCTISALATE | PERENNEBELL Co., Ltd. | 3690af2b-fe22-3a9a-e063-6294a90a709d | 2025-06-10 | Warnings | M020 |
| Zinc Oxide | PACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 COOL/DEEP | Pacifica Beauty, LLC | 373901f7-0e32-0f32-e063-6394a90abe25 | 2025-06-10 | Warnings | M020 |
| Zinc Oxide | PACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 WARM/TAN | Pacifica Beauty, LLC | 37397b96-ef14-9098-e063-6294a90aafc9 | 2025-06-10 | Warnings | M020 |
| Zinc Oxide | PACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 WARM/LIGHT | Pacifica Beauty, LLC | 373aba7c-2ae1-8726-e063-6294a90ae3d8 | 2025-06-10 | Warnings | M020 |
| Zinc Oxide | PACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 NATURAL/MEDIUM | Pacifica Beauty, LLC | 373c29b9-2f75-9777-e063-6394a90a68a6 | 2025-06-10 | Warnings | M020 |
| Hydrating Sheer Lip Balm Trio The Neutrals Broad Spectrum SPF 30 | AVOBENZONE, OCTISALATE, AND HOMOSALATE | MDSolarSciences | 374395ea-ab91-de70-e063-6394a90aec56 | 2025-06-10 | Warnings | M020 |
| ANDALOU NATURALS DEEP HYDRATION DAILY SHADE BLUE LIGHT DEFENSE FACIAL SPF 30 | ZINC OXIDE | Andalou naturals | aa689e82-6512-46d8-aec9-269f9348d3f8 | 2025-06-09 | Warnings | M020 |
| ALLIES OF SKIN The One SPF-50 Invisible Sunscreen | AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE | ALLIES GROUP PTE. LTD. | 36e1c61c-33ab-4a5d-853d-119c29632b08 | 2025-06-09 | Warnings | M020 |
| SHISEIDO ULTIMATE SUN PROTECTION S | TITANIUM DIOXIDE AND ZINC OXIDE | Shiseido Americas Corporation | b2fae1ba-67fe-48ef-b31f-62db34349961 | 2025-06-09 | Warnings | M020 |
| Olay Super Cream with Sunscreen Broad Spectrum SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | The Procter & Gamble Manufacturing Company | 372819f1-0813-2cd5-e063-6294a90ac5bf | 2025-06-09 | Warnings | M020 |
| Naturium Phyto-Glow Lip Balm SPF 45-Clear | AVOBENZONE, HOMOSALATE, OCTISALATE | e.l.f. Cosmetics, Inc. | 3806e2f2-ffd1-6d69-e063-6394a90acb44 | 2025-06-09 | 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 |