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 |
|---|---|---|---|---|---|---|
| Banana Boat Sport Ultra Broad Spectrum SPF 50 Plus Sunscreen Lip Balm | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | c7a3c03b-7fee-404c-e053-2a95a90a3a97 | 2025-12-04 | Warnings | M020 |
| Poolside Bronze Service Instant bronzing lotion. SPF30 | HOMOSALATE,OCTOCRYLENE, OCTISALATE,OCTINOXATE, AVOBENZONE | Longway Technology(Guangzhou)Co.,Ltd. | 4524129b-f8aa-171b-e063-6294a90aeebe | 2025-12-04 | Warnings | M020 |
| Solbar Zinc SPF38 | SOLBAR ZINC SPF38 | Person and Covey | fac62a2f-92ee-4afd-9999-bc5011159e43 | 2025-12-04 | Warnings | M020 |
| elf Sun Boss Gloss SPF 25 Sunscreen Pink Me Girl | ZINC OXIDE | e.l.f. Cosmetics, Inc. | 6c316ce4-c2f6-4633-a789-e786d0f76abd | 2025-12-04 | Warnings | M020 |
| Poolside Frostbite Sunscreen coconut SPF 15 Scented lip gloss | HOMOSALATE, OCTOCRYLENE, OCTISALATE , AVOBENZONE | Longway Technology(Guangzhou)Co.,Ltd. | 452b5f2c-b61f-8915-e063-6294a90ac911 | 2025-12-04 | Warnings | M020 |
| Poolside Frostbite Sunscreen watermelon SPF 15 Scented lip gloss | HOMOSALATE , OCTOCRYLENE, OCTISALATE, AVOBENZONE | Longway Technology(Guangzhou)Co.,Ltd. | 452b6e12-1bf9-8093-e063-6394a90a9e74 | 2025-12-04 | Warnings | M020 |
| Poolside Frostbite Sunscreen Papaya SPF 15 Scented lip gloss | HOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONE | Longway Technology(Guangzhou)Co.,Ltd. | 452b6f22-5080-86ab-e063-6394a90a0416 | 2025-12-04 | Warnings | M020 |
| Poolside Golden Hour SPF15 sunscreen lip oil | HOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONE | Longway Technology(Guangzhou)Co.,Ltd. | 452b8393-1887-a660-e063-6394a90a4c2b | 2025-12-04 | Warnings | M020 |
| Poolside Sun Daze Body Illuminator SPF 30 shimmer sunscreen gel | HOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONE | Longway Technology(Guangzhou)Co.,Ltd. | 452b8dde-dd63-b585-e063-6394a90a3543 | 2025-12-04 | Warnings | M020 |
| Binda Botanicals Baby and Kids Sunscreen SPF50 | ZINC OXIDE SUNSCREEN | VEGANIC SKN LIMITED | 452b9b7d-4049-b483-e063-6394a90a5358 | 2025-12-04 | Warnings | M020 |
| BINDA Face and Body Sunscreen SPF50 | ZINC OXIDE SUNSCREEN | VEGANIC SKN LIMITED | 386f5013-430c-e07f-e063-6394a90a32a8 | 2025-12-04 | Warnings | M020 |
| Poolside Not Your Babys Oil. SPF 30 sunscreen body oil. | HOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONE | Longway Technology(Guangzhou)Co.,Ltd. | 452bcb25-848c-e8a7-e063-6394a90ace0f | 2025-12-04 | Warnings | M020 |
| Sugargirl Glowy face screen sunbeam shimmer sunscreen for the face SPF 30 | HOMOSALATE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, AVOBENZONE | Longway Technology(Guangzhou)Co.,Ltd. | 452bd1d2-6a9f-f5e8-e063-6394a90ac9e3 | 2025-12-04 | Warnings | M020 |
| Poolside Butter SCREEN SPF 30 sunscreen Butter | HOMOSALATE , OCTOCRYLENE , OCTISALATE , AVOBENZONE | Longway Technology(Guangzhou)Co.,Ltd. | 452bd24d-8654-e6c0-e063-6394a90a0aea | 2025-12-04 | Warnings | M020 |
| Poolside Glow Butter Screen SPF 30 Shimmer sunscreen Butter | HOMOSALATE , OCTOCRYLENE, OCTISALATE , AVOBENZONE | Longway Technology(Guangzhou)Co.,Ltd. | 452bd69e-02c7-fcbd-e063-6394a90ae59b | 2025-12-04 | Warnings | M020 |
| Softlips Cherry | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | bececc42-1321-430a-80ef-438060fdcc86 | 2025-12-04 | Warnings | M020 |
| ATTITUDE Sunly Lip Balm SPF 15 Watermelon | ZINC OXIDE | 9055-7588 Qubec Inc.DBA ATTITUDE | 450d038b-3f99-add8-e063-6294a90aee9a | 2025-12-03 | Warnings | M020 |
| Natrience Broad Spectrum SPF 30 | SKIN SHIELD | Sisel International, LLC | 1989370f-68a6-6f22-e063-6394a90aacaf | 2025-12-03 | Boxed warning, Warnings | M020 |
| ATTITUDE Super leaves Lip Balm SPF 15 Coconut | ZINC OXIDE | 9055-7588 Qubec Inc.DBA ATTITUDE | 450d8fd0-20ad-1920-e063-6394a90a7271 | 2025-12-03 | Warnings | M020 |
| ATTITUDE Super leaves Lip Balm SPF 15 Exotic | ZINC OXIDE | 9055-7588 Qubec Inc.DBA ATTITUDE | 450db2bb-1788-efc2-e063-6294a90a13c0 | 2025-12-03 | 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 |