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 |
|---|---|---|---|---|---|---|
| EELHOE Airy Sunstick | TITANIUM DIOXIDE | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 45328c13-31ae-3bd2-e063-6394a90a814f | 2025-12-05 | Warnings | M020 |
| Srubs Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | ITW Pro Brands | 06c1dc42-5a01-f898-e063-6394a90a1a1a | 2025-12-05 | Warnings | M020 |
| OUHOE Tinted Sunscreen | TITANIUM DIOXIDE | Shantou Ouhoe Technology Co., Ltd. | 4540f542-248d-bcf5-e063-6294a90aabca | 2025-12-05 | Warnings | M020 |
| No 7 Restore and Renew Multi Action Fragrance Free Day Cream SPF 25 | AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | BCM Cosmetique SAS | 45c7703b-7ab4-2ef2-e063-6294a90a2b46 | 2025-12-05 | Warnings | M020 |
| No7 Restore and Renew Multi Action Day Cream Sunscreen Broad Spectrum SPF 25 | AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | BCM Cosmetique SAS | 4645b051-ef5a-521e-e063-6294a90a2404 | 2025-12-05 | Warnings | M020 |
| SPF 50 Mineral Sunscreen bkids | ZINC OXIDE | KAS Direct LLC dba BabyGanics | f717cd89-194b-42e3-a079-24b2903deb29 | 2025-12-05 | Warnings | M020 |
| Sugargirl Set SPF 30 sunscreen shimmer sunscreen mist for the face | HOMOSALATE , OCTOCRYLENE ,OCTISALATE , AVOBENZONE | Longway Technology(Guangzhou)Co.,Ltd. | 451b662a-70ed-8ec5-e063-6294a90a005b | 2025-12-04 | Warnings | M020 |
| Sugargirl SPF 30 sunscreen illuminating stick sunlight | HOMOSALATE ,OCTOCRYLENE ,OCTISALATE , AVOBENZONE | Longway Technology(Guangzhou)Co.,Ltd. | 451b71a9-2240-853f-e063-6394a90ac8f4 | 2025-12-04 | Warnings | M020 |
| Poolside Orange Creme SPF 30 SCENTED gel sunscreen | HOMOSALATE,OCTOCRYLENE,OCTISALATE,OCTIONXATE,AVOBENZONE | Longway Technology(Guangzhou)Co.,Ltd. | 451b7229-67d1-8b0e-e063-6394a90ab71e | 2025-12-04 | Warnings | M020 |
| Sugargirl SPF 30 sunscreen illuminating stick solar | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | Longway Technology(Guangzhou)Co.,Ltd. | 451b7229-67d3-8b0e-e063-6394a90ab71e | 2025-12-04 | Warnings | M020 |
| Poolside Sun Silk Body Cream SUNGLOW 05 FRAGRANCE Sunscreen SPF 30 body cream | HOMOSALATE, OCTOCRYENE, OCTISALATE, QCTINOXATE, AVOBENZONE | Longway Technology(Guangzhou)Co.,Ltd. | 451b86fa-6c1c-a708-e063-6394a90a47a9 | 2025-12-04 | Warnings | M020 |
| Poolside Clear Intentions Invisible Face Sunscreen SPF 30 | HOMOSALATE, OCTOCRYLENE, OCTISALATE,OCTINOXATE, AVOBENZONE | Longway Technology(Guangzhou)Co.,Ltd. | 451b902d-892d-15f1-e063-6294a90a3024 | 2025-12-04 | Warnings | M020 |
| Sugargirl sun gloss SPF15 tinted lip gloss Sunscreen Vanilla Icing | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | Longway Technology(Guangzhou)Co.,Ltd. | 451ba227-7973-1378-e063-6294a90ae893 | 2025-12-04 | Warnings | M020 |
| Sugargirl sun gloss SPF15 tinted lip gloss Sunscreen Pink Ice | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | Longway Technology(Guangzhou)Co.,Ltd. | 451ba704-6fbd-d5a0-e063-6394a90a2fbc | 2025-12-04 | Warnings | M020 |
| Sugargirl sun gloss SPF15 tinted lip gloss Sunscreen Tropic Twist | HOMOSALATE,OCTOCRYLENE, OCTISALATE, AVOBENZONE | Longway Technology(Guangzhou)Co.,Ltd. | 451bb62e-b603-7663-e063-6294a90a46db | 2025-12-04 | Warnings | M020 |
| Prequel Lip Visor SPF 30 ROSEDUST | LIP 30 CLEAR | The Center Brands, LLC | 33d5e1ad-ba7a-25f8-e063-6294a90aa38e | 2025-12-04 | Warnings | M020 |
| Resting Beach Face SPF30 Anti-Pollution Sunscreen Serum | BUTYL METHOXYDIBENZOYLMETHANE, HOMOSALATE, OCTYL SALICYLATE, OCTOCRYLENE | Everyday Group Limted | 54f8aca8-fbbc-498a-aaf8-aee716511dde | 2025-12-04 | Warnings | M020 |
| Oh My Bod SPF50 Antioxidant Infused Dry Touch Sunscreen | BUTYL METHOXYDIBENZOYLMETHANE, HOMOSALATE, OCTOCRYLENE, OCTYL SALICYLATE | Everyday Group Limted | 48e70326-ecf7-44c9-a4cc-2044bd6a6415 | 2025-12-04 | Warnings | M020 |
| LIGHTSAVE TRIPLESOME SERUM TINTED | ZINC OXIDE | Reve Skincare LLC | 35f5652f-3e6b-71c9-e063-6294a90a9e86 | 2025-12-04 | Warnings | M020 |
| LIGHTSAVE TRIPLESOME SERUM IVORTY | ZINC OXIDE | Reve Skincare LLC | 35f4dd1b-c3d9-8408-e063-6394a90a7914 | 2025-12-04 | 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 |