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_7af0f836-c146-4bbf-b8e6-40e25f9a9723
- 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 | 46783-002-50 | D | Discontinued by firm | 2026-10-15 |
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 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4Y5P7MUD51 | Internal UNII lookup |
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e120a659-0dfc-42ca-8158-58e8a0b457e5 | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| Zealios Mineral SPF 30 Sunscreen | ZINC OXIDE | Personal Best Products Inc. dba Zealios | c421b00c-6536-4455-81f6-01686f8c2388 | 2026-02-03 | Warnings | M020 |
| Zealios Sport Performance Ultralight SPF 50 Sunscreen | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Personal Best Products Inc. dba Zealios | 020bd1b4-da50-4117-a4f3-b74aa4187396 | 2026-02-03 | Warnings | M020 |
| Adrien Arpel Daily Defense Moisturizer SPF 30 | AVOBENZONE, OCTISALATE, OCTOCRYLENE | Color Me Beautiful Inc | f65e1428-b79a-4126-862a-907ca17ee8f7 | 2026-02-02 | Warnings | M020 |
| Flori Roberts Daily Defense Moisturizer SPF 30 | AVOBENZONE, OCTISALATE, OCTOCRYLENE | Color Me Beautiful Inc | 934d6b80-0cc3-4dcd-a25d-2191bd273618 | 2026-02-02 | Warnings | M020 |
| Dr.Oracle AIR FIT DEFENSE SOOTHING SUNSCREEN | HOMOSALATE, OCTYL SALICYLATE, TITANIUM DIOXIDE, ZINC OXIDE | Oracle Cosmetic Co., Ltd. | 21424f78-f8d5-6a9b-e063-6294a90ab7dc | 2026-02-02 | Warnings | M020 |
| HAMPTON SUN SPF50 SUNSHIELD BODY GLOW | HOMOSALATE 10% OCTOCRYLENE 10% AVOBENZONE 3% OCTICALATE 5% | S&C Hampton Sun LLC | 26190992-9463-47ae-86a5-0dbc05be8773 | 2026-02-02 | Warnings | M020 |
| Sunscreen | AVOBENZONE, HOMOSALATE,OTISALATE, OCTOCRYLENE | Rite Aid Corporation | fe9146ec-b85d-43da-a391-377960f2c772 | 2026-02-02 | Warnings, Adverse reactions | M020 |
| sheer | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Rite Aid Corporation | 299a6690-9746-4410-a625-7636f0b4a754 | 2026-02-02 | Warnings, Adverse reactions | M020 |
| Dr. C. Tuna Sun Stick SPF 50 | AVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENE | Farmasi US LLC | 49dc6040-b400-7f5b-e063-6394a90ac7d7 | 2026-02-02 | Warnings | M020 |
| Naturium Dew Glow Moisturizer Mineral SPF 50 | ZINC OXIDE | e.l.f. Cosmetics, Inc | 535f798f-d21d-92b2-e063-6294a90a72c7 | 2026-02-02 | Warnings | M020 |
| Sol de Janiero Rio Radiance SPF 50 Body | ZINC OXIDE | Cosmetic Solutions LLC | 2d54727d-5dcc-4792-85e8-1a2f21fe9e3d | 2026-02-02 | Warnings | M020 |
| Sky and Sol Face and Body Sunscreen Spf 50 | ZINC OXIDE | Delta Ecommerce LLC | 47d9dc66-328f-4cab-e063-6394a90a279d | 2026-02-01 | Warnings | M020 |
| e.l.f. Suntouchable Invisi-Stick Glitz SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f cosmetics,Inc. | 4b801bb3-8930-7e04-e063-6294a90adaa1 | 2026-02-01 | Warnings | M020 |
| SHISEIDO ULTIMATE SUN PROTECTOR CLEAR | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Shiseido Americas Corporation | cedd7a3e-3334-437f-a283-482bcd0064ee | 2026-01-30 | Warnings | M020 |
| SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Shiseido Americas Corporation | bf16e8b5-b717-4255-a7da-9abe3d1ad8b4 | 2026-01-30 | Warnings | M020 |
| Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Rite Aid Corporation | 372a8fba-b190-40fe-a1fc-fecf7f7afc35 | 2026-01-30 | Warnings, Adverse reactions | M020 |
| ALOE UP MEDICATED LIP BALM SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | Aloe Care International, LLC | 859b6d3f-b1ca-4966-8f0c-f9afa0d5864c | 2026-01-30 | Warnings | M020 |
| ALOE UP SPORT NATURAL BALM SPF-15 | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Aloe Care International, LLC | 3de029ed-97f7-4cb3-a32e-d412bf3b5874 | 2026-01-30 | Warnings | M020 |
| Reef safe unscented SPF 50 mineral sunscreen 01 | TITANIUM DIOXIDE, ZINC OXIDE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 49a77ad4-508c-9617-e063-6394a90a5623 | 2026-01-30 | Warnings | M020 |
| JOSIE MARAN ARGAN SUN MILK MINERAL SUNSCREEN BROAD SPECTRUM SPF 33 | TITANIUM DIOXIDE AND ZINC OXIDE | Cosmetic Solutions LLC | d65ae1c9-dff5-4612-b8be-fa59bba03b81 | 2026-01-30 | 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 |