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 | 2026-10-27 | |
| excluded package | package | 46783-002 | 46783-002-03 | D | Discontinued by firm | 2026-10-27 | |
| excluded package | package | 46783-002 | 46783-002-05 | D | Discontinued by firm | 2026-10-27 | |
| excluded package | package | 46783-002 | 46783-002-50 | D | Discontinued by firm | 2026-10-27 |
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 |
|---|---|---|---|---|---|---|
| Quick Screen Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | The Quick Flick PTY LTD | 3788666e-7efa-43da-95f5-6218b7fcb6ea | 2025-02-12 | Warnings | M020 |
| Dolce AND Gabbana Get Your Healthy Glowy Skin | ZINC OXIDE | Socoplan | 91bf1cca-8d18-4c59-864d-4fd0619c6713 | 2025-02-12 | Warnings | M020 |
| Cell Fusion C Aquatica UV Defense Sunscreen Broad Spectrum SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CMS LAB Inc. | 2dfd1f99-5896-1e0f-e063-6394a90aa71d | 2025-02-12 | Warnings | M020 |
| Biore Aqua Rich UV | OCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATE | KAO USA | f9024581-dbab-b7cb-e053-6294a90a8b9a | 2025-02-12 | Warnings | M020 |
| Dr Loretta Universal Glow Daily Defense SPF 40 | ZINC OXIDE | Dr. Loretta, LLC | ebdaf6c1-1572-4840-851b-6d780471fcb2 | 2025-02-11 | Warnings | M020 |
| Sky and Sol Body Sunscreen SPF50 | SKY AND SOL BODY SUNSCREEN SPF50 | Guangzhou Fantesy Biotechnology Co.,Ltd | 2de9173b-fa02-8017-e063-6394a90ae0aa | 2025-02-11 | Warnings | M020 |
| Beeswax SPF 15 Broad Spectrum Lip Balm | BEESWAX SPF 15 BROAD SPECTRUM LIP BALM | Raining Rose, Inc | 2dcc2f9b-4a8c-b281-e063-6294a90ad9d6 | 2025-02-10 | Warnings | M020 |
| Broad Spectrum SPF 30 Tropical Sunscreen | BROAD SPECTRUM SPF 30 TROPICAL SUNSCREEN | Raining Rose, Inc | 2dcca380-c0e4-4e04-e063-6394a90ac31e | 2025-02-10 | Warnings | M020 |
| Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Sunscreen Deep | ENSULIZOLE, OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE | Amway Corp | 88021a24-d3b5-48f8-8d26-affbfcfd098f | 2025-02-10 | Warnings | M020 |
| Sun Defense Minerals (Sheer) | ZINC OXIDE, TITANIUM DIOXIDE | Eminence Organic Skin Care | 2dd20800-2cf9-02d4-e063-6294a90a0f00 | 2025-02-10 | Warnings | M020 |
| Bondi Sands Fragrance Free Face SPF 50 Sunscreen Mist | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | BONDI SANDS (USA) INC. | 2dd5ea23-eee6-5d14-e063-6294a90a0fd3 | 2025-02-10 | Warnings | M020 |
| Centella Calming SUNSCREEN | CENTELLA CALMING SUNSCREEN | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 2dc0ee9b-d58b-fe40-e063-6394a90af439 | 2025-02-09 | Warnings | M020 |
| SOME BY MI V10 HYAL LIP SUN PROTECTOR ROSY | AVOBENZONE, HOMOSALATE, OCTISALATE | PERENNEBELL Co., Ltd | 2dc25afb-a171-f1f2-e063-6294a90ae333 | 2025-02-09 | Warnings | M020 |
| SOME BY MI V10 HYAL LIP SUN PROTECTOR BERRY | AVOBENZONE, HOMOSALATE, OCTISALATE | PERENNEBELL Co., Ltd | 2dc285ad-08cd-14e6-e063-6294a90a24fc | 2025-02-09 | Warnings | M020 |
| PROBIOTIC RICE Sunscreen | PROBIOTIC RICE SUNSCREEN | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 2d9d6440-39b3-312a-e063-6394a90aa072 | 2025-02-08 | Warnings | M020 |
| NIA 24 SPF 30 | HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE | Niadyne Inc | e5c9d56f-48b4-4f0e-add6-f73268755b16 | 2025-02-07 | Warnings | M020 |
| Pacific Mango Sunscreen SPF 30 | AVOBENZONE, OCTISALATE, OCTOCRYLENE | SAN DIEGO NATURAL SOAP COMPANY | d09e3096-0678-4433-a555-61f18a45873b | 2025-02-06 | Warnings | M020 |
| DR.JART CICAPAIR TIGER GRASS COLOR CORRECTING TREATMENT | ZINC OXIDE, TITANIUM DIOXIDE | Have & Be Co., Ltd. | 01cfe6a6-c2e4-8fb8-e063-6294a90adc78 | 2025-02-06 | Warnings | M020 |
| Dr.Jart Premium Beauty Balm Medium-Tan | ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE | Have & Be Co., Ltd. | 02a8bab8-ca5d-6b65-e063-6294a90abb07 | 2025-02-06 | Warnings | M020 |
| Dr.Jart Premium Beauty Balm Fair-Light | ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE | Have & Be Co., Ltd. | 02a82029-bdb1-cbe0-e063-6294a90a08f3 | 2025-02-06 | 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 |