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 |
|---|---|---|---|---|---|---|
| Coppertone Kids Sport Sunscreen SPF 100 | AVOBENZONE 3%, HOMOSALATE 15%, OCTINOXATE 2% OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6% | Beiersdorf Inc | c068a6e7-260f-0766-e053-2995a90a422f | 2025-12-31 | Warnings | M020 |
| Coppertone Sport Suncreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5% | Beiersdorf Inc | cc43f433-51ff-ed6a-e053-2a95a90ad3c5 | 2025-12-31 | Warnings | M020 |
| Coppertone Sport Mineral Sunscreen SPF 50 | ZINC OXIDE | Beiersdorf Inc | b5bb6eb6-3356-e2a5-e053-2995a90aa684 | 2025-12-31 | Warnings | M020 |
| Coppertone Limited Edition Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5% | Beiersdorf Inc | ccbf7795-e153-1a43-e053-2a95a90ad4b6 | 2025-12-31 | Warnings | M020 |
| Eucerin Advanced Hydration SPF 50 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Beiersdorf Inc | cd9cbdb4-42f1-3063-e053-2a95a90a08aa | 2025-12-31 | Warnings | M020 |
| Eucerin Baby Sensitive Mineral SPF 50 Sunscreen | ZINC OXIDE | Beiersdorf Inc | cdb19c82-9845-eabc-e053-2a95a90a31f7 | 2025-12-31 | Warnings | M020 |
| Eucerin Advance Hydration Sunscreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Beiersdorf Inc | cd61e4d7-776d-8d84-e053-2995a90a4819 | 2025-12-31 | Warnings | M020 |
| Eucerin Oil-Control SPF 50 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Beiersdorf Inc | cda04484-ba84-2276-e053-2a95a90a41c8 | 2025-12-31 | Warnings | M020 |
| Coppertone Kids Sunscreen SPF 60 | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | 240dd76a-8f39-caec-e063-6294a90abbbc | 2025-12-31 | Warnings | M020 |
| Coppertone Protect and Tan SPF 30 | AVOBENZONE 3%, HOMOSALATE 14%, OCTISALATE 4.5%, OCTOCRYLENE 9% | Beiersdorf Inc | d3994886-2ebe-a9d2-e053-2995a90aaf9a | 2025-12-31 | Warnings | M020 |
| Coppertone Waterbabies Pure and Simple Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9% | Beiersdorf Inc | d3d471b8-7430-98b0-e053-2995a90aba4b | 2025-12-31 | Warnings | M020 |
| Coppertone Sport Sunscreen SPF 60 | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | 241f78be-0d7f-c5ca-e063-6294a90a997a | 2025-12-31 | Warnings | M020 |
| Coppertone Protect and Tan Sunscreen SPF 45 | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdort Inc | d39a009d-1f33-88bb-e053-2a95a90a03a0 | 2025-12-31 | Warnings | M020 |
| Coppertone Sport Sunscreen SPF 30 | AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7% | Beiersdorf Inc | d460d669-42df-46c0-e053-2a95a90ad77b | 2025-12-31 | Warnings | M020 |
| Coppertone Tanning Sunscreen SPF 8 | AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3% | Beiersdorf Inc | d370094c-3373-594b-e053-2a95a90a114a | 2025-12-31 | Warnings | M020 |
| Coppertone Tanning Sunscreen SPF 15 | (TO DELIVER) AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7% | Beiersdorf Inc | 0a5a35be-9e24-18dd-e063-6394a90a097f | 2025-12-31 | Warnings | M020 |
| Coppertone Sport Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5% | Beiersdorf Inc | d462081f-f082-5df2-e053-2995a90aa1d9 | 2025-12-31 | Warnings | M020 |
| Coppertone Waterbabies Pure and Simple Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9% | Beiersdorf Inc | d3e66496-bc3c-d189-e053-2a95a90a06b6 | 2025-12-31 | Warnings | M020 |
| Coppertone Kids Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5% | Beiersdorf Inc. | c05388dc-4282-ee79-e053-2a95a90a376a | 2025-12-31 | Warnings | M020 |
| Coppertone Glow Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9% | Beiersdorf Inc | b60dcbd1-42d0-646f-e053-2a95a90a497d | 2025-12-31 | 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 |