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 | 2026-10-27 | |
| excluded package | package | 46783-002 | 46783-002-03 | D | Discontinued by firm | 2026-10-27 | |
| excluded package | package | 46783-002 | 46783-002-05 | D | Discontinued by firm | 2026-10-27 | |
| excluded package | package | 46783-002 | 46783-002-50 | D | Discontinued by firm | 2026-10-27 |
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 |
|---|---|---|---|---|---|---|
| City Skin Age Defense Broad Spectrum SPF 50 | TITANIUM DIOXIDE AND ZINC OXIDE | Murad, LLC | f8c572a2-b4bc-49e9-95df-359f05bd69b7 | 2025-03-28 | Warnings | M020 |
| HEB SPF 50 Rejuvenate Sunscreen with Moisturizing Oils and Vitamins Continuous Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | H.E.B | 314c54ed-32f8-5c20-e063-6394a90a0af5 | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( blueberry) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 314f8990-4b33-e2b1-e063-6394a90a4d79 | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( bubble gum) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 31507a62-09a7-6bcc-e063-6394a90aa575 | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( Birthday cake) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 3152bd5d-474f-e392-e063-6294a90aa930 | 2025-03-27 | Warnings | M020 |
| Lip Balm SPF15 Bubble Gum Flavored | LIP BALM SPF15 BUBBLE GUM FLAVORED | LS Promotions Inc | 3152bd5d-4750-e392-e063-6294a90aa930 | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( Cocount Pina Colada) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 31538f32-9f71-bd40-e063-6394a90a1cd8 | 2025-03-27 | Warnings | M020 |
| Lip Balm SPF15 Birthday Cake flavored | LIP BALM SPF15 BIRTHDAY CAKE FLAVORED | LS Promotions Inc | 3153bc6a-8f60-ea37-e063-6294a90acd97 | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( Apple pie) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 3153e1fe-1c43-def0-e063-6294a90a6b3a | 2025-03-27 | Warnings | M020 |
| Lip Balm SPF15 Strawberry Shortcake flavored | LIP BALM SPF15 STRAWBERRY SHORTCAKE FLAVORED | LS Promotions Inc | 315402e4-c1ec-150f-e063-6294a90ae29e | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( Vanilla) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 3154206c-00b3-e5e3-e063-6394a90afee8 | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( Passion Fruit) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 31544568-c556-72b2-e063-6294a90ace91 | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( Peppermint) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 31548583-ecc7-2e1e-e063-6394a90a2402 | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( strawberry) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 3154b0f0-2025-4514-e063-6394a90a70c4 | 2025-03-27 | Warnings | M020 |
| Lip Balm SPF15 Tropical Punch Flavored | LIP BALM SPF15 TROPICAL PUNCH FLAVORED | LS Promotions Inc | 3154ae45-e075-f53b-e063-6294a90aed5b | 2025-03-27 | Warnings | M020 |
| Lip Balm SPF15 Passion Fruit flavored | LIP BALM SPF15 PASSION FRUIT FLAVORED | LS Promotions Inc | 31552e96-980c-8120-e063-6294a90af3da | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( tropical punch) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 315579e7-e1fb-d6f5-e063-6294a90af06a | 2025-03-27 | Warnings | M020 |
| Shea Moisture | NOURISHED AND RADIANT BROAD SPECTRUM SPF 30 SUNSCREEN FACE LOTION | Conopco d/b/a/ Unilever | 3159be1c-9678-5b1a-e063-6294a90acd08 | 2025-03-27 | Warnings | M020 |
| CeraVe Facial Moisturizing with Sunscreen Broad Spectrum SPF 30 | HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDE | LOreal USA Products Inc | 7d9e8c07-d295-4c8e-a52f-bdb509dc489b | 2025-03-27 | Warnings | M020 |
| Superactive Moisturizer SPF 50 Mattifying Oil plus Pore Control SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Murad, LLC | 8d89ebf5-bcd5-4fde-a7d4-059023e00f33 | 2025-03-27 | 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 |