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 |
|---|---|---|---|---|---|---|
| SHISEIDO BENEFIANCE WRINKLERESIST24 DAY | AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | 7d9c0f81-005f-4223-940e-a64143db5275 | 2026-01-06 | Warnings | M020 |
| SHISEIDO FUTURE Solution LX INFINITE TREATMENT PRIMER | TITANIUM DIOXIDE, OCTINOXATE, AND ENSULIZOLE | SHISEIDO AMERICAS CORPORATION | ff088b0c-27c9-4ea8-bf94-6261378c7190 | 2026-01-06 | Warnings | M020 |
| Drs. pharmacy sunscreen SPF 50 (physical filters) | SUNSCREEN SPF 50 | OL PHARMA TECH LLC. (Drs. Pharmacy) | 31e976a2-0623-0dca-e063-6394a90a08da | 2026-01-06 | Warnings | M020 |
| SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 115 Fair Shirakaba | OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | 26151cf4-0fee-4a42-92fd-4d7b9cef8381 | 2026-01-06 | Warnings | M020 |
| Drs. pharmacy sunscreen SPF 50 (physical filters) | SUNSCREEN SPF 50 | OL PHARMA TECH LLC. (Drs. Pharmacy) | 315a5ca4-4536-d585-e063-6294a90a1c50 | 2026-01-06 | Warnings | M020 |
| Drs. pharmacy sunscreen SPF 30 (Physical Filters) | SUNSCREEN SPF 30 | OL PHARMA TECH LLC. (Drs. Pharmacy) | 315a5b1f-9dc2-a243-e063-6394a90a5e08 | 2026-01-06 | Warnings | M020 |
| SHISEIDO ULTIMATE SUN PROTECTOR | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | 51f759b7-8c49-41d4-aaa3-f901d599cac5 | 2026-01-06 | Warnings | M020 |
| cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED n (Refill) | AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | 463dc557-9743-4a38-969e-2c78fc10ee2a | 2026-01-06 | Warnings | M020 |
| CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n | AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE | SHISEIDO AMERICAS CORPORATION | 23bb4225-bfb5-47e2-80fe-733761ba4069 | 2026-01-06 | Warnings | M020 |
| SHISEIDO WHITE LUCENT DAY | AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | e881e637-e0f0-4c90-8343-2be6e74020b8 | 2026-01-06 | Warnings | M020 |
| Hawaiian Tropic Lip Balm Sunscreen SPF 30 | AVOBENZONE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | c7b71be3-f906-bd09-e053-2995a90adc61 | 2026-01-06 | Warnings | M020 |
| SHISEIDO BENEFIANCE WRINKLERESIST24 DAY | AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | d308d578-c881-4c10-8c79-9e3cd58b694c | 2026-01-06 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 051b7413-8f1b-7135-e063-6294a90a9364 | 2026-01-06 | Warnings | M020 |
| Coppertone Sport Sunscreen Lip Balm SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, | Beiersdorf Inc | 47bc6776-1130-0162-e063-6294a90a2adc | 2026-01-06 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 088fa3cd-b9b8-d10b-e063-6394a90a7fd6 | 2026-01-06 | Warnings | M020 |
| SPF 50 Florida Sun Defense Broad Spectrum SPF 50 Sunscreen Body Oil | HOMOSALATE, OCTISALATE, OCTOCRYLENE | Naples Soap Company, Inc. | 47c147a9-c4f4-ab82-e063-6394a90aaa5c | 2026-01-06 | Warnings | M020 |
| PoutScreen Lip Treatment Love Letter | AVOBENZONE, OCTINOXATE, OCTOCRYLENE | NAKED SUNDAYS PTY LTD | 47d22c6d-49fd-f97c-e063-6294a90a6ba1 | 2026-01-06 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands, LLC | 56ab90db-51bd-ffb3-e063-6294a90a852b | 2026-01-06 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands, LLC | 56ac28e7-41f1-bd4e-e063-6294a90a0e7b | 2026-01-06 | Warnings | M020 |
| Moisturizing Antioxidant SPF 50 | OCTINOXATE, OCTISALATE, HOMOSALATE, OXYBENZONE, ZINC OXIDE | Topiderm, Inc. | 727c14d3-ad26-4e8b-91f6-b7a5f07e4e2f | 2026-01-05 | 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 |