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 |
|---|---|---|---|---|---|---|
| Pelotan Sunscreen Broad Spectrum SPF 30 | AVOBENZONE, OCTINOXATE, OCTOCRYLENE | Pelotan LLC | 3a9f94eb-98b7-5a20-e063-6394a90a173b | 2025-07-23 | Warnings | M020 |
| Basin Frosted Orange Cream SPF 15 Broad Spectrum Sunscreen Lip Balm | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Retail Concepts of Minnesota, Inc. | 3a9fc050-f74f-a431-e063-6294a90ad4c2 | 2025-07-23 | Warnings | M020 |
| Pelotan Sunscreen Broad Spectrum SPF 30 | AVOBENZONE, OCTINOXATE, OCTOCRYLENE | Pelotan LLC | 3aa0799b-0790-2476-e063-6294a90a8bcc | 2025-07-23 | Warnings | M020 |
| The Men Pen TALLOW GUARD SPF 30 PREMIUM ZINC SUNSCREEN | ZINC OXIDE | Guangzhou Haishi Biological Technology Co., Ltd. | 3aa3c442-26a6-0ab0-e063-6294a90a93a5 | 2025-07-23 | Warnings | M020 |
| Basin Italian Gelato SPF 15 Broad Spectrum Sunscreen Lip Balm | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Retail Concepts of Minnesota, Inc. | 3a89106d-dbf0-e6ea-e063-6294a90a60f3 | 2025-07-22 | Warnings | M020 |
| Basin American Mint Julep SPF 15 Broad Spectrum Sunscreen Lip Balm | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Retail Concepts of Minnesota, Inc. | 3a898964-b4aa-e86d-e063-6394a90a34c6 | 2025-07-22 | Warnings | M020 |
| No7 Future Renew Damage Reversal System Kit | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | BCM Cosmetique SAS | 3512c120-b8ba-ba59-e063-6394a90ac1e2 | 2025-07-22 | Warnings | M020 |
| Basin Lime Sugar SPF 15 Broad Spectrum Sunscreen Lip Balm | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Retail Concepts of Minnesota, Inc. | 3a89d736-efef-088e-e063-6394a90a5e62 | 2025-07-22 | Warnings | M020 |
| Basin Juicy Watermelon SPF 15 Broad Spectrum Sunscreen Lip Balm | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Retail Concepts of Minnesota, Inc. | 3a8a093b-cc9c-26fc-e063-6394a90a2028 | 2025-07-22 | Warnings | M020 |
| Basin Coconut SPF 15 Broad Spectrum Sunscreen Lip Balm | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Retail Concepts of Minnesota, Inc. | 3a8a87d6-ef86-60c2-e063-6394a90a0706 | 2025-07-22 | Warnings | M020 |
| Basin Eucalyptus Mint SPF 15 Broad Spectrum Sunscreen Lip Balm | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Retail Concepts of Minnesota, Inc. | 3a8b773c-f456-836a-e063-6294a90a0d46 | 2025-07-22 | Warnings | M020 |
| Basin Strawberry SPF 15 Broad Spectrum Sunscreen Lip Balm | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Retail Concepts of Minnesota, Inc. | 3a8bc90d-350f-98c8-e063-6294a90abd9c | 2025-07-22 | Warnings | M020 |
| Basin Peach Apricot SPF 15 Broad Spectrum Sunscreen Lip Balm | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Retail Concepts of Minnesota, Inc. | 3a8bd5d8-1c4c-0407-e063-6394a90a138f | 2025-07-22 | Warnings | M020 |
| CLEAR GLOW RADIANT SUN SERUM SPF50 | AVOBENZONE 15MG/G, HOMOSALATE 5MG/G, OCTOCRYLENE 25MG/G, (SUNSCREEN) | NAKED SUNDAYS PTY LTD | d748e291-3a29-663c-e053-2995a90a8d92 | 2025-07-22 | Warnings | M020 |
| La Defense Broad Spectrum SPF 30 Mineral Sunscreen | ZINC OXIDE, TITANIUM DIOXIDE | Luzern Laboratories, Inc | 3f00befa-415d-415d-89e1-6ba8770ba51e | 2025-07-21 | Warnings | M020 |
| PREDIRE PARIS skin shield protector mineral defense cream | PREDIRE PARIS SKIN SHIELD PROTECTOR MINERAL DEFENSE CREAM | Guangzhou Fantesy Biotechnology Co.,Ltd | 3a7c1345-532f-b38f-e063-6394a90a5245 | 2025-07-21 | Warnings | M020 |
| Medicated Peppermint Lip Balm | DIMETHICONE, UNSPECIFIED, OCTINOXATE, AND OCTISALATE | Blistex Inc | 5d48a6fa-ddce-47c3-9b09-1f3abb695017 | 2025-07-18 | Warnings | M020 |
| ICD Moisture Layer Sunscreen | HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE | ICD Moisture Layer Sunscreen | 3a2a74f2-9fed-808f-e063-6294a90a410c | 2025-07-18 | Warnings | M020 |
| Counter Beauty Dew Skin Tinted Moisturizer No. 2 | ZINC OXIDE | G2G Ventures, PBC | 3a35c95b-10eb-689f-e063-6394a90ae1d4 | 2025-07-18 | Warnings | M020 |
| Counter Beauty Dew Skin Tinted Moisturizer No. 3 | ZINC OXIDE | G2G Ventures, PBC | 3a35bbb2-a1eb-346b-e063-6294a90a9078 | 2025-07-18 | 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 |