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 | 2026-10-21 | |
| excluded package | package | 46783-002 | 46783-002-03 | D | Discontinued by firm | 2026-10-21 | |
| excluded package | package | 46783-002 | 46783-002-05 | D | Discontinued by firm | 2026-10-21 | |
| excluded package | package | 46783-002 | 46783-002-50 | D | Discontinued by firm | 2026-10-21 |
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 |
|---|---|---|---|---|---|---|
| Dr. Idriss Major Fade Disco Block Whipped Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE | PILLOWTALKDERM LLC | 30e10a62-8430-649b-e063-6394a90a97eb | 2025-11-11 | Warnings | M020 |
| Essential Defense Mineral Shield Broad Spectrum SPF 32 Sunscreen TINTED | TITANIUM DIOXIDE AND ZINC OXIDE | Allergan, Inc. | 279a5214-79b2-44e9-b003-378d0b992395 | 2025-11-11 | Warnings | M020 |
| Tinted Moisturizer SPF 46 Universal Tint | ZINC OXIDE, OCTINOXATE | Drmtlgy, LLC | 5304b568-f891-4094-9182-363ae7bcfbe4 | 2025-11-11 | Warnings | M020 |
| C Lip Serum Mineral Broad Spectrum SPF 30 | SUNSCREEN | Simply Active Cosmetics | 323661a6-3602-1ce2-e063-6394a90a8e91 | 2025-11-10 | Warnings | M020 |
| buttah Tinted Mineral Sunscreen SPF-30 | TITANIUM DIOXIDE, ZINC OXIDE | Buttah Enterprises, LLC. | 43458152-0775-dd9c-e063-6394a90a6140 | 2025-11-10 | Warnings | M020 |
| Aspen Glow 100% Mineral Broad Spectrum SPF 30 Powder Sunscreen 0.16 oz / 4.6 g | ZINC OXIDE | Aspen Glow Cosmetics, LLC | 142eda44-76e1-7960-e063-6394a90a9ad6 | 2025-11-10 | Warnings | M020 |
| TriLipiderm Broad Spectrum SPF 30 | BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL METHOXYCINNAMATE, HOMOSALATE, OCTOCRYLENE | TriLipid Research Institute, LLC | 617fc696-c2a1-4855-bafb-0454e6497101 | 2025-11-10 | Warnings | M020 |
| TriLipiderm Protective Day | HOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE,BUTYL METHOXYDIBENZOYLMETHANE, OCTOCRYLENE | TriLipid Research Institute, LLC | 66726c2b-27e9-5dd1-e053-2991aa0a1ba7 | 2025-11-10 | Warnings | M020 |
| Eucerin Sensitive Mineral SPF 50 Sunscreen | ZINC OXIDE | Beiersdorf Inc | cdb25154-e4e3-efc7-e053-2a95a90a2df6 | 2025-11-10 | Warnings | M020 |
| ESSENCE BY CATHERINE HINDS Broad Spectrum MINERAL PROTECTION SPF 50 | ZINC OXIDE | Catherine Hinds Company, Inc. | 956e6643-51c9-49c4-bd68-f5ee1b0ae4e0 | 2025-11-10 | Warnings | M020 |
| GoodSense SPF 50 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Geiss, Destin, & Dunn, Inc. | c85d59a1-6ae1-bb2e-e053-2995a90af20e | 2025-11-09 | Warnings | M020 |
| GoodSense SPF 30 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 6% | Geiss, Destin, & Dunn, Inc. | c85c5d2b-35f6-2fd5-e053-2995a90a4a53 | 2025-11-09 | Warnings | M020 |
| Walgreens SPF 50 Tinted Mineral Fluid | TITANIUM DIOXIDE | Walgreens | 345918e3-95f8-404c-e063-6394a90a3fca | 2025-11-09 | Warnings | M020 |
| Gold Dynamics Skin Boosting Moisturizer Broad Spectrum SPF 15 Sunscreen | AVOBENZONE, OXYBENZONE, OCTISALATE, OCTINOXATE | Distribuidora Comercial Jafra, S.A. de C.V. | ad6646c7-c6aa-4610-a0c7-ddd1ddd13cde | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 500 W | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | d690d5d1-e1fa-404f-a17e-7b97be17b44a | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 510 C | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 2fbdeff7-4880-49ef-bb4d-e033d18e0459 | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 540 N | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 6a86e5fd-6736-45e0-aa7d-d268fdaed4f8 | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 560 C | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 42a3625f-5c58-4ec5-895f-b14f74428271 | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 415 C | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 8e14fe81-cf7f-4a81-afec-e6c8466179c9 | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 425 N | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 7dd9f4cb-78d8-4edc-a63c-d4a02930a0f8 | 2025-11-07 | 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 |