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 Every Tone Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9% | Beiersdorf Inc | f3e3f4c6-2cb9-7b17-e053-2a95a90a3854 | 2025-12-31 | Warnings | M020 |
| Coppertone Every Tone Age Defense Sunscreen SPF 60 | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | 23f88c88-b68e-4706-e063-6294a90afb38 | 2025-12-31 | Warnings | M020 |
| Coppertone Complete Sunscreen SPF 30 | AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 8% | Beiersdorf Inc | d473113d-2fc3-6b1c-e053-2a95a90a88ed | 2025-12-31 | Warnings | M020 |
| Coppertone Sport Sunscreen SPF 30 | AVOBENZONE 3%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 6% | Beiersdorf Inc | d89df7a5-7741-3e1d-e053-2995a90ae275 | 2025-12-31 | Warnings | M020 |
| Coppertone Complete Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5% | Beiersdorf Inc | d475e14f-dab1-dec5-e053-2995a90aef73 | 2025-12-31 | Warnings | M020 |
| Coppertone Complete Sunscreen SPF 30 | AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7% | Beiersdorf Inc | d4757d99-bac6-48fb-e053-2a95a90ab1bf | 2025-12-31 | Warnings | M020 |
| Coppertone Sunscreen SPF 60 | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | 24d3fbbc-0bce-b47a-e063-6394a90a9afa | 2025-12-31 | Warnings | M020 |
| Sei Bella CC Brightening Creme Light | OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1% | Melaleuca Inc. | 6894b9d9-a5b5-4c98-e053-2991aa0a9ca2 | 2025-12-31 | Warnings | M020 |
| Sei Bella CC Brightening Creme Fair | OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1% | Melaleuca Inc. | 6892952a-d032-30bf-e053-2a91aa0a3bba | 2025-12-31 | Warnings | M020 |
| Sei Bella CC Brightening Creme Medium Tan | OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1% | Melaleuca Inc. | 68a4e8b4-36cb-6306-e053-2a91aa0a6d25 | 2025-12-31 | Warnings | M020 |
| Sei Bella CC Brightening Creme Medium | OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1% | Melaleuca Inc. | 68a4ed34-f492-67a6-e053-2a91aa0a0428 | 2025-12-31 | Warnings | M020 |
| Sei Bella Daily UV Defense Broad-Spectrum SPF 25 Sunscreen | SUNSCREEN | Melaleuca Inc. | 1f1d1575-cf37-5d66-e063-6394a90ab2a3 | 2025-12-31 | Warnings | M020 |
| Eucerin Daily Hydration | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Beiersdorf Inc | c9bb7d33-783b-4cbb-a130-91f92d4cc137 | 2025-12-31 | Warnings | M020 |
| Sei Bella Tinted BB Moisturizing Creme Sheer to Light 140 N | TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% | Melaleuca Inc. | a13e5326-73c3-9fa8-e053-2a95a90aae9d | 2025-12-31 | Warnings | M020 |
| Sei Bella Tinted BB Moisturizing Creme Sheer to Light 20 N | TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% | Melaleuca Inc. | a13e3f45-8e6f-6a3f-e053-2995a90a17d2 | 2025-12-31 | Warnings | M020 |
| Sei Bella Tinted BB Moisturizing Creme Deep 550 N | TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% | Melaleuca Inc. | 68e31a82-0cd0-5a1a-e053-2991aa0a33f8 | 2025-12-31 | Warnings | M020 |
| Sei Bella Tinted BB Moisturizing Creme Light to Medium 200 N | TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% | Melaleuca Inc. | 68e2dfaa-d173-e6a9-e053-2a91aa0a4663 | 2025-12-31 | Warnings | M020 |
| Sei Bella Tinted BB Moisturizing Creme Medium 300 W | TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% | Melaleuca Inc. | 68e2e541-c583-0f12-e053-2991aa0a4ab2 | 2025-12-31 | Warnings | M020 |
| Sei Bella Tinted BB Moisturizing Creme Medium to Deep 500 W | TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% | Melaleuca Inc. | 68e30231-4fba-35d4-e053-2991aa0a33cb | 2025-12-31 | Warnings | M020 |
| Sei Bella Tinted BB Moisturizing Creme Medium 440 N | TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% | Melaleuca Inc. | 68e30255-5640-3b4a-e053-2991aa0ab3f7 | 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 |