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 |
|---|---|---|---|---|---|---|
| Gold Dynamics Skin Boosting Moisturizer Broad Spectrum SPF 15 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENE | Distribuidora Comercial Jafra, S.A. de C.V. | 03b0f2ee-526b-4513-b70a-2918ad322b5e | 2025-11-19 | Warnings | M020 |
| Invisible Sunscreen SPF 40 | HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE | PARTICLE AESTHETIC SCIENCE LTD | 1b33b4fb-1deb-69f7-e063-6294a90a9cc0 | 2025-11-19 | Warnings | M020 |
| Softlips Vanilla | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 8dff782f-7201-4ad9-94d2-672058f817b8 | 2025-11-19 | Warnings | M020 |
| Lanolips Sun Balm Tropical Untinted Lip Balm Broad Spectrum SPF30 | AVOBENZONE, OXTINOXATE, OCTOCRYLENE, OXYBENZONE | Baxter Laboratories Pty. Ltd. | 43923c68-87ad-1ab7-e063-6394a90adf7a | 2025-11-18 | Warnings | M020 |
| Illuminizing Blendrops Broad Spectrum SPF 46 | HOMOSALATE, OCTISALATE, ZINC OXIDE | Wasatch Product Development, LLC | 43e36351-4caf-3393-e063-6394a90a00b1 | 2025-11-18 | Warnings | M020 |
| Perfecting Blendrops Broad Spectrum SPF 46 | HOMOSALATE, OCTISALATE, ZINC OXIDE | Wasatch Product Development, LLC | 43e454cf-dac8-4c2f-e063-6394a90a7097 | 2025-11-18 | Warnings | M020 |
| Hill Country Fare Morning Facial Moisturizing with Broad Spectrum SPF 30 Sunscreen | HOMOSALATE, OCTOCRYLENE, ZINC OXIDE | H.E.B. | 43e55eb7-6572-bd88-e063-6294a90aa7ee | 2025-11-18 | Warnings | M020 |
| ANTI-AGING COMPLEX BROAD SPECTRUM SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | Merle Norman Cosmetics, Inc. | d10272ea-aedd-5759-e053-2a95a90a3ab3 | 2025-11-18 | Warnings | M020 |
| DAYDREAM Broad Spectrum Sunscreen SPF 40 | ZINC OXIDE | Drmtlgy, LLC | bd0981cb-49ce-4eaf-bd9e-db48f56b7314 | 2025-11-18 | Warnings | M020 |
| SPF 25 LIP BALM | AVOBENZONE, OCTISALATE, HOMOSALATE | Drmtlgy, LLC | 8aed2fb0-f7b8-4ff0-b597-144c0557789e | 2025-11-18 | Warnings | M020 |
| Sunny Defense Sunscreen Stick | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | RBGROUP Co., Ltd | 262450f0-c4a1-dcca-e063-6394a90ae3cd | 2025-11-17 | Warnings | M020 |
| Tone Blur Essence Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | RBGROUP Co., Ltd | 1814b5e7-5bbf-df16-e063-6294a90a96c4 | 2025-11-17 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 17N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 43c48c66-bd5b-0024-e063-6394a90a6c7b | 2025-11-17 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 19C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 43c512da-e4b6-dd9c-e063-6294a90a1730 | 2025-11-17 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 21N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 43c52258-2549-c42b-e063-6394a90a1526 | 2025-11-17 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 21W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 43c59de6-8eb2-d00a-e063-6294a90a0b04 | 2025-11-17 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 24W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 43c5bd02-62e0-019a-e063-6294a90adcf3 | 2025-11-17 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 23W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 43c5d54e-119c-0c6d-e063-6394a90aba4c | 2025-11-17 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 25N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 43c5eb1c-b268-acfb-e063-6394a90ad4cc | 2025-11-17 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 27C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 43c6157a-4b62-8279-e063-6294a90abe05 | 2025-11-17 | 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 |