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 |
|---|---|---|---|---|---|---|
| Perfect Sunscreen SPF 50 Sheer Mineral | ZINC OXIDE | Bluemercury, Inc. | d8f483ff-b990-40c5-b5b8-00065051ae7e | 2025-12-09 | Warnings | M020 |
| Foto Facial Age Delay Non-Tinted | TITANIUM DIOXIDE ZINC OXIDE | ADVANCED AESTHETIC DERMATOLOGY | 42674013-fa2b-42d7-e063-6294a90af999 | 2025-12-09 | Warnings | M020 |
| Hydraboost Moisturizer SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Bluemercury | eca867e6-4deb-4be2-ae3f-6850fb6223b3 | 2025-12-09 | Warnings | M020 |
| Foto Facial Age Delay Matte Tinted | TITANIUM DIOXIDE ZINC OXIDE | ADVANCED AESTHETIC DERMATOLOGY | 42761919-8ae2-3c41-e063-6394a90abb8f | 2025-12-09 | Warnings | M020 |
| Dew Mineral | ZINC OXIDE | ADVANCED AESTHETIC DERMATOLOGY | 42f17245-92a9-3915-e063-6394a90a6817 | 2025-12-09 | Warnings | M020 |
| Mineral Sunscreen Non-Tinted | TITANIUM DIOXIDE, ZINC OXIDE | YUMA ACNE CLINIC, L.L.C. | 3c69b707-07ff-1a82-e063-6394a90a9fcd | 2025-12-09 | Warnings | M020 |
| Mineral Sunscreen Tinted | TITANIUM DIOXIDE, ZINC OXIDE | YUMA ACNE CLINIC, L.L.C. | 3c69f93f-0385-365c-e063-6394a90a12fd | 2025-12-09 | Warnings | M020 |
| Replenishing Daily Protection Tinted | ZINC OXIDE | YUMA ACNE CLINIC, L.L.C. | 3c6a5601-a7a2-5e20-e063-6394a90a6643 | 2025-12-09 | Warnings | M020 |
| Bronzing Blendrops Broad Spectrum SPF 40 | HOMOSALATE, OCTISALATE, ZINC OXIDE | Wasatch Product Development, LLC | 124ca946-8412-4d6d-e063-6294a90a6338 | 2025-12-09 | Warnings | M020 |
| Perfecting Blendrops Broad Spectrum SPF 40 | HOMOSALATE, OCTISALATE, ZINC OXIDE | Wasatch Product Development, LLC | 12512cac-652e-b138-e063-6394a90ad1f2 | 2025-12-09 | Warnings | M020 |
| Mineral Lip Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | ASHLEY SAMAI | 38f457fa-0e95-7298-e063-6394a90adda8 | 2025-12-09 | M020 | |
| Non-Tinted Mineral Sunscreen | ZINC OXIDE | OLGA KLIMOV INC | 387b41a4-057f-88af-e063-6394a90adbbe | 2025-12-09 | M020 | |
| Tinted Replenishing Daily Protection | ZINC OXIDE | OLGA KLIMOV INC | 387b8ae6-c48b-905c-e063-6394a90a31fb | 2025-12-09 | M020 | |
| Tinted Primer Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | CECILIA EDWARDS | 36ea709b-3536-5052-e063-6394a90a48f9 | 2025-12-09 | M020 | |
| Age Defying Mineral Protection | TITANIUM DIOXIDE, ZINC OXIDE | MARK SCHWARTZ CLINICAL SKINCARE, INC. | 3b028159-f240-2cf2-e063-6294a90a32b5 | 2025-12-09 | Warnings | M020 |
| Ultimate Mineral Protection | ZINC OXIDE | MARK SCHWARTZ CLINICAL SKINCARE, INC. | 3b02bf69-b648-56e1-e063-6294a90aeef3 | 2025-12-09 | Warnings | M020 |
| G.M. Collin FPS-SPF 45 UVA-UVB TINTED SUNSCREEN | ZINC OXIDE, TITANIUM DIOXIDE | LABORATOIRES DERMO-COSMETIK INC. | 01dcfd14-7a1d-98fa-e063-6294a90a0336 | 2025-12-09 | Warnings | M020 |
| Tinted Primer Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | CECILIA EDWARDS | 3aff2074-1514-b5c5-e063-6394a90a7572 | 2025-12-09 | M020 | |
| Mineral Lip Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER | 3729d270-64ac-4d2e-e063-6294a90aeb2c | 2025-12-09 | M020 | |
| Non Tinted Replenishing Daily Protection | ZINC OXIDE | LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER | 372a41f6-40f6-4971-e063-6394a90a83e0 | 2025-12-09 | 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 |