CoTZ Face Prime and Protect SPF 40 (Non-Tinted)
- Product NDC
- 58892-348
- 11-digit product format
- 588920348
- Labeler code
- 58892
- Product ID
- 58892-348_9498c109-3155-481c-a847-975cb655f6bc
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Titanium Dioxide, Zinc Oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Fallien Cosmeceuticals, LTD
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-11-15
- Substance
- TITANIUM DIOXIDE; ZINC OXIDE
- Active strength
- 80; 38 mg/g; mg/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 58892-348 | U | Excluded because listing certification expired | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… | ||
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 58892-348 | 58892-348-45 | U | Excluded because listing certification expired | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… |
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
- CoTZ Face Prime and Protect SPF 40 (Non-Tinted)
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TITANIUM DIOXIDE | 80 mg/g |
| ZINC OXIDE | 38 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 15FIX9V2JP | Internal UNII lookup |
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f106f52b-2157-46c7-9f7c-50f43a649050 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58892-348-45 | CoTZ Face Prime and Protect SPF 40 (Non-Tinted) | 42.5 g in 1 TUBE | CREAM | 42.5 | 2 | |
| 58892-348-45 | CoTZ Face Prime and Protect SPF 40 (Non-Tinted) | 1 in 1 CARTON | CREAM | 1 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58892-348 | COTZ FACE PRIME AND PROTECT SPF 40 (NON-TINTED) (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD] | 2 | Current NDC, Legacy NDC, 2 package rows | 20250112_f106f52b-2157-46c7-9f7c-50f43a649050.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 |
|---|---|---|---|---|---|---|
| RECHARGE Protect Blur | TITANIUM DIOXIDE, ZINC OXIDE | Rodan & Fields Beauty, LLC | c787e3b9-33b1-4c47-95bd-b14cf6558938 | 2025-12-08 | Warnings | M020 |
| Mineral Mist SPF-50 | TITANIUM DIOXIDE, ZINC OXIDE | TUBBY TODD | dca54a19-af25-ce47-e053-2a95a90a22db | 2025-12-07 | Warnings | M020 |
| Inblair Elevate SPF15 Moisturizer | INBLAIR ELEVATE SPF15 MOISTURIZER | Guangzhou Fantesy Biotechnology Co.,Ltd | 4567d413-d8cc-677b-e063-6294a90a1a42 | 2025-12-07 | Warnings | M020 |
| HANCHOBIT Radiant Pink Tone Up Sun Cream | TITANIUM DIOXIDE | HANCHOYEANBIOTEC Co.,Ltd. | 45685047-166d-8af5-e063-6294a90aa7be | 2025-12-07 | Warnings | M020 |
| EELHOE Moisturiser Sun Stick | TITANIUM DIOXIDE | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 454004c9-07fa-64ad-e063-6394a90a0c8a | 2025-12-06 | Warnings | M020 |
| OUHOE Daily Exposure Lightweight Sunscreen | TITANIUM DIOXIDE | Shantou Ouhoe Technology Co., Ltd. | 454301b6-21a6-6153-e063-6294a90a1366 | 2025-12-06 | Warnings | M020 |
| OUHOE Cotton Soft Sun Stick | TITANIUM DIOXIDE | Shantou Ouhoe Technology Co., Ltd. | 4543a43e-acf7-6759-e063-6394a90a2f53 | 2025-12-06 | Warnings | M020 |
| OUHOE Centella Daily Sun | TITANIUM DIOXIDE | Shantou Ouhoe Technology Co., Ltd. | 4544f3a3-8c52-ea54-e063-6394a90a7a9c | 2025-12-06 | Warnings | M020 |
| EELHOE All Day Light Sunscreen Mist | TITANIUM DIOXIDE | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 45323ca3-c706-dcb5-e063-6394a90a96f7 | 2025-12-05 | Warnings | M020 |
| 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 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58892-348-45 | 58892034845 | 1 TUBE in 1 CARTON (58892-348-45) / 42.5 g in 1 TUBE | 1 tube | 2018-11-15 | 0000-00-00 | No | No | Current |