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 |
|---|---|---|---|---|---|---|
| ST MORIZ SUNCARE BODY SUNSCREEN SPF30 | SUNCARE BODY SUNSCREEN SPF30 | Aopline Biotechnology (Guangzhou) Co., Ltd. | 48026f09-6d15-8fa6-e063-6294a90a17cb | 2026-01-09 | Warnings | M020 |
| RODAN and FIELDS ENHANCEMENTS MEDIUM | TITANIUM DIOXIDE, ZINC OXIDE | Bentley Laboratories, LLC | 6aa6ad3f-2c52-4031-9e6c-7526c42de71d | 2026-01-09 | Warnings | M020 |
| FACE SPF 47 SETTING | FACE SPF 47 SETTING SPRAY | Aopline Biotechnology (Guangzhou) Co., Ltd. | 47db9a54-c02f-d2ea-e063-6394a90ab973 | 2026-01-08 | Warnings | M020 |
| BADABOOM SUNSCREEN | SUNSCREEN | Aopline Biotechnology (Guangzhou) Co., Ltd. | 47dbf363-2892-4530-e063-6294a90abe1f | 2026-01-08 | Warnings | M020 |
| ROE WELLNESS SPF 50 MINERAL | SPF 50 MINERAL POWDER | Aopline Biotechnology (Guangzhou) Co., Ltd. | 47dc8155-4abb-4bb7-e063-6294a90af1ad | 2026-01-08 | Warnings | M020 |
| ALOHA MINERAL BLOCK-BRUSH ON MINERAL | SUNSCREEN SPF50 | Aopline Biotechnology (Guangzhou) Co., Ltd. | 47dd07aa-71b4-5d54-e063-6394a90a4127 | 2026-01-08 | Warnings | M020 |
| SUNSCREEN SETTING SPRITZ, SPF 45 | SUNSCREEN SETTING SPRAY | Aopline Biotechnology (Guangzhou) Co., Ltd. | 47ddf752-cae2-313f-e063-6294a90a7e3a | 2026-01-08 | Warnings | M020 |
| St Moriz suncare face sunscreen spf50 | OCTOCRYLENE, OCTISALATE , AVOBENZONE , HOMOSALATE | Aopline Biotechnology (Guangzhou) Co., Ltd. | 47df072e-151f-eb30-e063-6294a90a4eeb | 2026-01-08 | Warnings | M020 |
| SUNSCREEN GLOWING | AVOBENZONE ,OCTISALATE ,OCTOCRYLENE , HOMOSALATE | Aopline Biotechnology (Guangzhou) Co., Ltd. | 47df0de5-012a-c896-e063-6394a90a9cef | 2026-01-08 | Warnings | M020 |
| BANANA BOAT | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Edgewell Personal Care Brands LLC | 616d35f6-63d2-3d26-e053-2991aa0a5b44 | 2026-01-08 | Warnings | M020 |
| BANANA BOAT | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Edgewell Personal Care Brands LLC | 616d35a1-a139-1974-e053-2a91aa0a20b6 | 2026-01-08 | Warnings | M020 |
| PIPA SKIN CARE SUN-SATIONAL Mineral Sunscreen | SPF 30 | EVI LABS | 258b7b7c-a3f2-172c-e063-6394a90aec6a | 2026-01-08 | Warnings | M020 |
| DMK Ultrascreen Mineral Sunscreen | ZINC OXIDE | Danne Montague King | 3f022275-c1e5-2704-e063-6294a90a4a81 | 2026-01-08 | Warnings | M020 |
| Anhydrous SPF 30 | TITANIUM DIOXIDE, ZINC OXIDE | Owen Biosciences, Inc. | 0cc8221d-5ec5-4abf-a4f5-ab06e8dcea68 | 2026-01-08 | Warnings | M020 |
| Rejuvaskin Mineral Facial Sunscreen SPF 32 Sheer | REJUVASKIN MINERAL FACIAL SUNSCREEN SPF 32 SHEER | Atlantic Medical Products, LLC | 47e5198e-7bf6-72a8-e063-6294a90a7ec5 | 2026-01-08 | Warnings | M020 |
| inde wild SUN DEFENSE SPF 50 SUNSCREEN GLOW DROPS BROAD SPECTRUM | INDE WILD SUN DEFENSE GLOW DROPS | INDE WILD PRIVATE LIMITED | 47e57407-2925-09ca-e063-6294a90a49ec | 2026-01-08 | Warnings | M020 |
| NIDA Invisible Fit Sunscreen | SUNSCREEN | Proso Corp | 47ed3b62-45ef-b67a-e063-6294a90a317b | 2026-01-08 | Warnings | M020 |
| Organic Matters SPF 50 Sunscreen | ZINC OXIDE | Veganic SKN Limited | 12f37c8d-07f0-3e75-e063-6294a90a2cdf | 2026-01-08 | Warnings | M020 |
| Ellegreen Sunscreen Broad Spectrum SPF50 | ZINC OXIDE | Veganic SKN Limited | 161a7209-10d8-928c-e063-6394a90a4139 | 2026-01-08 | Warnings | M020 |
| Live Sunny Eco-zinc hydrating mineral sunscreen for body and face | ZINC OXIDE | Veganic SKN Limited | 1a97169e-67be-3d25-e063-6294a90a3b88 | 2026-01-08 | 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 |