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 |
|---|---|---|---|---|---|---|
| First Aid Beauty FAB Ultra Repair Face Moisturizer with Sunscreen Broad Spectrum SPF 30 | OCTOCRYLENE, AND ZINC OXIDE | The Procter & Gamble Manufacturing Company | f6801575-6081-7566-e053-2995a90a20a8 | 2025-12-18 | Warnings | M020 |
| Olay Regenerist Regenerating with Sunscreen Broad Spectrum SPF 15 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | The Procter & Gamble Manufacturing Company | 00280745-908b-468f-e063-6294a90aa12f | 2025-12-18 | Warnings | M020 |
| OLAY Prime plus Protect Facial Sunscreen with Vitamin C SPF35 Matte Finish | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | The Procter & Gamble Manufacturing Company | 10bd41ac-9b96-840d-e063-6394a90a98d9 | 2025-12-18 | Warnings | M020 |
| Olay Glow plus Protect Sunscreen Dewy Glow SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE | The Procter & Gamble Manufacturing Company | 10bc4127-7569-d0de-e063-6294a90a97bf | 2025-12-18 | Warnings | M020 |
| First Aid Beauty FAB Hydrating Sunscreen Milk Broad Spectrum SPF 45 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | The Procter & Gamble Manufacturing Company | 29645d90-a444-4090-e063-6294a90ac7e3 | 2025-12-18 | Warnings | M020 |
| Skin On Skin BC Foundation SPF 40 - Tan Golden | OCTISALATE, HOMOSALATE, ZINC OXIDE | YENSA Beauty, LLC | 46440bac-de69-e59c-e063-6394a90a76c0 | 2025-12-18 | Warnings | M020 |
| FUSIDYNE DERMA TROUBLE Zinc Calming Sunscreen | ZINC OXIDE | DONG WHA PHARM. CO., LTD. | 46457c78-74d6-ea6a-e063-6294a90a24ac | 2025-12-18 | Warnings | M020 |
| THE MUG GUARD Invisible Gel Suncare for Face | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Dune Suncare, Inc. | 4646988c-1060-ed5f-e063-6394a90aa765 | 2025-12-18 | Warnings | M020 |
| Sage and Zinc Facial Hydrating SPF15 | ZINC OXIDE | Emeis Cosmetics Pty Ltd | ccabd647-ecdd-7230-e053-2a95a90a7a96 | 2025-12-18 | Warnings | M020 |
| Avail Facial Sunscreen SPF 25 | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | Emeis Cosmetics Pty Ltd | 7be903e4-5f07-35b2-e053-2991aa0a1340 | 2025-12-17 | Warnings | M020 |
| Mineral Sheer Stick | ZINC OXIDE | Supergoop, LLC | 0beed72e-51df-d15a-e063-6394a90af559 | 2025-12-17 | Warnings | M020 |
| Sunscreen Lotion118ml | ZINC OXIDE 12%,TITANIUM DIOXIDE 6%, HOMOSALATE 14%,OCTISALATE 5% | Foshan Sugar Max Cosmetics CO.,Ltd | 4620c41a-2188-00f5-e063-6394a90a613c | 2025-12-17 | Warnings | M020 |
| Sunscreen Cream | ZINC OXIDE 15%,TITANIUM DIOXIDE 6%,HOMOSALATE 5%,OCTISALATE 4% | Foshan Sugar Max Cosmetics CO.,Ltd | 46224dbe-a0fb-c242-e063-6394a90a2634 | 2025-12-17 | Warnings | M020 |
| CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 0N | ENSULIZOLE, OCTISALATE | Parfums Christian Dior | 31141a45-54e2-4463-ab42-4df56d911650 | 2025-12-17 | Warnings | M020 |
| Perricone High Potency Face Finishing and Firming Moisturizer | TITANIUM DIOXIDE, ZINC OXIDE | THG Beauty USA LLC | 2409cea1-7077-dc12-e063-6294a90a4558 | 2025-12-17 | Warnings | M020 |
| Tinted Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Glow Advanced Skin and Body Care, LLC | 3635a073-5484-f96c-e063-6394a90adef5 | 2025-12-17 | M020 | |
| Mineral Sunscreen Lip | TITANIUM DIOXIDE, ZINC OXIDE | Glow Advanced Skin and Body Care, LLC | 36362dc7-31d7-f766-e063-6294a90a129b | 2025-12-17 | M020 | |
| Mineral Sunscreen Non-Tinted | ZINC OXIDE | Glow Advanced Skin and Body Care, LLC | 3635e45b-6978-ac69-e063-6294a90a22ac | 2025-12-17 | M020 | |
| Prime and Protect | TITANIUM DIOXIDE, ZINC OXIDE | Shannon Cornelsen-Lewandowski | 36480f7f-37e8-decd-e063-6394a90ada60 | 2025-12-17 | M020 | |
| Prime and Protect | TITANIUM DIOXIDE, ZINC OXIDE | Shannon Cornelsen-Lewandowski | 364827bd-5781-eb53-e063-6394a90ab22f | 2025-12-17 | 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 |