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 |
|---|---|---|---|---|---|---|
| GOLDEN ROSE GLOW KISS TINTED LIP BALM CHOCO CAKE | AVOBENZONE, OCTINOXATE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | 8be1c27c-7988-47c4-b613-3bc86f53981e | 2025-08-08 | Warnings | M020 |
| GOLDEN ROSE GLOW KISS TINTED LIP BALM STRAWBERRY | AVOBENZONE, OCTINOXATE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | a3c8d778-ce9c-46eb-a0c3-6886eb1d3934 | 2025-08-08 | Warnings | M020 |
| GOLDEN ROSE glow kiss TINTED LIP BALM CHERRY JUICE | AVOBENZONE, OCTINOXATE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | 6cdb0b61-a9c2-4a78-9752-8e7aedaeef45 | 2025-08-08 | Warnings | M020 |
| GOLDEN ROSE GLOW KISS TINTED LIP BALM BERRY PINK | AVOBENZONE, OCTINOXATE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | f1b6c068-06d2-4a44-8199-7111d1b6a0d6 | 2025-08-08 | Warnings | M020 |
| GR LIP BUTTER COOKIE SPF 15 | AVOBENZONE, OCTINOXATE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | 0274f5f1-1ee1-48a5-af7a-deb3aa3a34d7 | 2025-08-08 | Warnings | M020 |
| GR LIP BUTTER ICE MINT SPF 15 | AVOBENZONE, OCTINOXATE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | a355777b-2cce-48ce-acc6-2aa7f154c4ba | 2025-08-08 | Warnings | M020 |
| GR LIP BUTTER RASPBERRY SPF 15 | AVOBENZONE, OCTINOXATE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | 5443202c-4f88-4063-a227-c50abbd480d6 | 2025-08-08 | Warnings | M020 |
| SUNSCREEN SPF50 | ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE, TITANIUM DIOXIDE | Guangzhou Tinsun Biotechnology Company Limited | 3bc1c6e9-1dd5-d7c6-e063-6394a90ad89e | 2025-08-07 | Warnings | M020 |
| Lipid Shield SPF 30 | ZINC OXIDE | Allure Labs | 3bce820a-147b-5d8b-e063-6294a90a570d | 2025-08-07 | Warnings | M020 |
| GR LONGSTAY Matte Face Powder SPF 15 | OCTINOXATE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | 62759398-4935-4732-b950-cfbeab82bc5a | 2025-08-07 | Warnings | M020 |
| Neutrogena Ultra Sheer Dry-Touch Sunscreen MAX Broad Spectrum SPF 100 Plus | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Kenvue Brands LLC | 3bac8d0a-8726-46c3-e063-6294a90a1075 | 2025-08-06 | Warnings | M020 |
| Tanning Club Golden Glow Tanning Oil SPF 15 | AVOBENZONE, OCTISALATE, OCTOCRYLENE | TANNING CLUB, LLC | 33478e28-b079-4e52-9924-845d127be286 | 2025-08-06 | Warnings | M020 |
| Tanning Club Everyday Sunscreen SPF 30 | HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE | TANNING CLUB, LLC | 805048c4-f2b3-4d35-8674-f44cf3d1a4b5 | 2025-08-06 | Warnings | M020 |
| PoolBar I Scream For Sunscreen SPF 50 Coconut and Vanilla | AVOBENZONE, OCTISALATE, OCTOCRYLENE | POOLBAR | deddb91d-b2d5-4d97-bc38-5c11abde9d43 | 2025-08-06 | Warnings | M020 |
| PoolBar I Scream For Sunscreen SPF 30 Coconut and Vanilla | AVOBENZONE, OCTISALATE, OCTOCRYLENE | POOLBAR | 7f16b91d-29e4-4c21-a008-5dcc858c83d8 | 2025-08-06 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 17W Medium | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 053cb3cd-dd16-4d08-b347-a4349fa37c07 | 2025-08-06 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 14W Light Medium | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 7bf90657-b636-41d6-b96c-88d174989f5b | 2025-08-06 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 15N Light Medium | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | da7e19cd-6a8b-47df-bfc9-2f0f11b7955c | 2025-08-06 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 16N Light Medium | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | f7a1d379-6de0-4be4-84a9-e0ebef332bef | 2025-08-06 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 18N Medium | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 671be8a6-51b7-45d2-9fff-c7736d2eea3e | 2025-08-06 | 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 |