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 | 2026-10-30 | |
| excluded package | package | 46783-002 | 46783-002-03 | D | Discontinued by firm | 2026-10-30 | |
| excluded package | package | 46783-002 | 46783-002-05 | D | Discontinued by firm | 2026-10-30 | |
| excluded package | package | 46783-002 | 46783-002-50 | D | Discontinued by firm | 2026-10-30 |
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 |
|---|---|---|---|---|---|---|
| BabyGanics Sunscreen 30 SPF | ZINC OXIDE, OCTINOXATE, AND OCTISALATE | KAS Direct LLC dba BabyGanics | 391a4ec3-b65b-4dbe-bc8f-cb67514c8ef1 | 2024-12-19 | Warnings | M020 |
| Light Illusion Luminous Makeup Nude-Skin Feel SPF18 PORCELAIN | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | COSMAX USA, INC | 299ac9a5-f609-d804-e063-6394a90abd05 | 2024-12-19 | Warnings | M020 |
| Light Illusion Luminous Makeup Nude-Skin Feel SPF18 IVORY | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | COSMAX USA, INC | 299ad424-16a8-66b1-e063-6394a90a0753 | 2024-12-19 | Warnings | M020 |
| Light Illusion Luminous Makeup Nude-Skin Feel SPF18 NUDE | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | COSMAX USA, INC | 299afef9-758f-74e1-e063-6294a90a8072 | 2024-12-19 | Warnings | M020 |
| Light Illusion Luminous Makeup Nude-Skin Feel SPF18 NATURAL BEIGE | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | COSMAX USA, INC | 299b3276-7973-d33f-e063-6294a90a6ce1 | 2024-12-19 | Warnings | M020 |
| Light Illusion Luminous Makeup Nude-Skin Feel SPF18 CLASSIC TAN | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | COSMAX USA, INC | 299afe24-d496-5745-e063-6394a90aa1b3 | 2024-12-19 | Warnings | M020 |
| Light Illusion Luminous Makeup Nude-Skin Feel SPF18 WARM BEIGE | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | COSMAX USA, INC | 299b1f9a-34fd-cb50-e063-6394a90af925 | 2024-12-19 | Warnings | M020 |
| Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SOFT SAND | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | COSMAX USA, INC | 299b3236-3f3d-c9e8-e063-6394a90a7443 | 2024-12-19 | Warnings | M020 |
| Light Illusion Luminous Makeup Nude-Skin Feel SPF18 TAWNY | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | COSMAX USA, INC | 299b416d-ce02-3462-e063-6294a90a38f0 | 2024-12-19 | Warnings | M020 |
| Puttisu | TITANIUM DIOXIDE, ZINC OXIDE | Jellycup, Inc. | a032331a-6724-d2cd-e053-2995a90ac15a | 2024-12-19 | Warnings | M020 |
| Dr. C. Tuna Resurface Essential Day Cream SPF 30 | HOMOSALATE, OCTINOXATE, OCTOCRYLENE, AVOBENZONE | Farmasi US LLC | de493e30-d135-9def-e053-2995a90ae49a | 2024-12-19 | Warnings | M020 |
| toty Ilumina CC Cream 1N | TITANIUM DIOXIDE, ZINC OXIDE | Chipican LLC | e4efe14e-7d46-78c0-e053-2995a90a2364 | 2024-12-19 | Warnings | M020 |
| Aruba Sun SPF 50 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Derma Care Research Labs, LLC | d8b28ce6-e938-c6e3-e053-2a95a90acc29 | 2024-12-19 | Warnings | M020 |
| DCH Pain Relief Roll-On | LIDOCAINE HCL 4% | Derma Care Research Labs, LLC | fda35d37-f36e-efc8-e053-6294a90a2bb8 | 2024-12-19 | Warnings | M020 |
| Black Girl Sunscreen SPF 50 Kids | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Derma Care Research Labs, LLC | d53ff8f5-0b06-1e8b-e053-2a95a90ab924 | 2024-12-19 | Warnings | M020 |
| Fresh Coast SPF 50 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Derma Care Research Labs, LLC | 043cadde-ba07-7c77-e063-6394a90abee6 | 2024-12-19 | Warnings | M020 |
| Black Girl Sunscreen SPF 30 | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 8% | Derma Care Research Labs, LLC | d438be95-0f88-69d7-e053-2995a90a982e | 2024-12-19 | Warnings | M020 |
| Pavin SPF 50 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Derma Care Research Labs, LLC | e945f9df-0aed-469c-e053-2995a90ab6aa | 2024-12-19 | Warnings | M020 |
| Bee Bald Smooth Plus Daily Moisturizer SPF 30 Sunscreen | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 2.7%, OXYBENZONE 6% | Derma Care Research Labs, LLC | 051b68f9-5d6b-3cd7-e063-6394a90aeb35 | 2024-12-19 | Warnings | M020 |
| MKMen Advanced Facial Hydrator Sunscreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | Mary Kay Inc. | 484e92db-09a2-4e93-aa7e-d91dbda31555 | 2024-12-19 | 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 |