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 |
|---|---|---|---|---|---|---|
| Perfect Glow BB Cream Sunscreen SPF 30 - Light Warm | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | Pur-lisse Beauty, LLC | 47325530-b097-db9a-e063-6294a90a335d | 2025-12-30 | Warnings | M020 |
| Perfect Glow BB Cream Sunscreen SPF 30 - Tan | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | Pur-lisse Beauty, LLC | 47328eb4-8ad7-28b5-e063-6294a90a20b1 | 2025-12-30 | Warnings | M020 |
| Perfect Glow BB Cream Sunscreen SPF 30 - Tan Deep | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | Pur-lisse Beauty, LLC | 4732bbec-d9f9-1639-e063-6394a90aff82 | 2025-12-30 | Warnings | M020 |
| Perfect Glow BB Cream Sunscreen SPF 30 - Deep | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | Pur-lisse Beauty, LLC | 4732ecd0-5261-7f11-e063-6394a90a26f3 | 2025-12-30 | Warnings | M020 |
| ScalpProtectionSpray | SCALP PROTECTION SPRAY | Naturich Labs | c227ff3a-bbbb-5cc5-e053-2a95a90a8e32 | 2025-12-30 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 0439b4b6-2792-3af1-e063-6294a90adcfe | 2025-12-30 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 0918fdd3-cffb-78e9-e063-6394a90ad5c7 | 2025-12-30 | Warnings | M020 |
| SLMD | AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE | Skin PS Brands | 1aa36c01-21b5-f06e-e063-6294a90a608f | 2025-12-30 | Warnings | M020 |
| Ageless Glow Serum BB Cream Sunscreen SPF 40 - Fair | HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE | Pur-lisse Beauty, LLC | 473738b4-7c36-8edf-e063-6394a90ad24b | 2025-12-30 | Warnings | M020 |
| Ageless Glow Serum BB Cream Sunscreen SPF 40 - Medium Tan | HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE | Pur-lisse Beauty, LLC | 47387d5f-e77b-5633-e063-6294a90a5584 | 2025-12-30 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 05b7aa44-cf8f-d77a-e063-6394a90a850b | 2025-12-30 | Warnings | M020 |
| Ageless Glow Serum BB Cream Sunscreen SPF 40 - Tan | HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE | Pur-lisse Beauty, LLC | 4738be66-0fe8-148e-e063-6394a90a1b02 | 2025-12-30 | Warnings | M020 |
| Ageless Glow Serum BB Cream Sunscreen SPF 40 - Tan Deep | HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE | Pur-lisse Beauty, LLC | 4738eed1-9f72-5fd8-e063-6394a90a26bd | 2025-12-30 | Warnings | M020 |
| Ageless Glow Serum BB Cream Sunscreen SPF 40 - Deep | HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE | Pur-lisse Beauty, LLC | 4739179e-88b3-8820-e063-6394a90aa211 | 2025-12-30 | Warnings | M020 |
| WHITE TEA TINTED MOISTURIZER | WHITE TEA TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN | GLOW CONCEPT INC | eb2df93f-6cdc-7ae8-e053-2a95a90a0091 | 2025-12-29 | Warnings | M020 |
| Hawaiian Natural Zinc Sunscreen SPF 50 | ZINC OXIDE | Kokua Sun Care | 64a5589b-735d-38ba-e053-2a91aa0ad8f4 | 2025-12-29 | Warnings | M020 |
| Hawaiian Natural Zinc Sunscreen Broad Spectrum Tinted SPF 30 | ZINC OXIDE | Kokua Sun Care | f9a12dac-2fd0-798f-e053-6394a90aa784 | 2025-12-29 | Warnings | M020 |
| Calming Days Vegan Sunscreen | ,OCTYL TRIAZONE (ETHYLHEXYL TRIAZONE), BISOCTRIZOLE, DIETHYLHEXYL BUTAMIDO TRIAZONE, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE | MERCYCO Co., Ltd. | 38898014-eefe-73ec-e063-6394a90a3738 | 2025-12-29 | Warnings | M020 |
| SPF 30 Sunscreen | ZINC OXIDE, TITANIUM DIOXIDE | CLEURE | f5512f34-08ee-b0f6-e053-2a95a90ab5bd | 2025-12-29 | Warnings | M020 |
| COCO AND EVE SUNNY HONEY PROTECT TAN BOOSTING ANTI-AGING SPF 20 | SUNSCREEN OIL | Soleil Collective LLC | 471b3028-2c13-ab70-e063-6394a90aa660 | 2025-12-29 | 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 |