CoTZ Face Prime and Protect SPF 40 (Non-Tinted)
- Product NDC
- 58892-348
- Requested package NDC
- 58892-348-45
- 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 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 |
|---|---|---|---|---|---|---|
| Sugargirl Glowy SPF 30 Face Screen Solar Shimmer Sunscreen for the face | HOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONE | Longway Technology(Guangzhou)Co.,Ltd. | 451bcab9-9b75-a17c-e063-6294a90aafd9 | 2025-12-23 | Warnings | M020 |
| DECORTE AQ ABSOLUTE TREATMENT AWAKENING PROTECTIVE DAY | AVOBENZONE, OCTINOXATE, OCTISALATE | KOS America, Inc. | 81352963-36ec-4099-af51-3498d89f3077 | 2025-12-23 | Warnings | M020 |
| Poolside Soft Serve Mineral Milk SPF 30 face sunscreen drops | ZINC OXIDE, OCTINOXATE | Longway Technology(Guangzhou)Co.,Ltd. | 451b4d37-99e2-8e4f-e063-6294a90a51bb | 2025-12-23 | Warnings | M020 |
| Reclaim Revolutionary Anti-Aging Day SPF15 | OCTINOXATE, OCTISALATE, AND OXYBENZONE | Guthy-Renker LLC | 4b735c91-f650-4531-8744-c211d57a3e28 | 2025-12-23 | Warnings | M020 |
| SCINIC ENJOY SUPER MILD SUN ESSENCE EX | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | ELEVEN STREET | 35272744-8253-046c-e063-6394a90aabc2 | 2025-12-22 | Warnings | M020 |
| TINTED FACIAL SUNSCREEN | ZINC OXIDE, TITANIUM DIOXIDE | Guangzhou Tata Biotechnology Co., Ltd. | 1259035e-9196-97de-e063-6394a90a9dec | 2025-12-22 | Warnings | M020 |
| SUNSCREEN LIP BALM | ETHYLHEXYL METHOXYCINNAMATE, HOMOSALATE, POLYSILICONE-15, OCTOCRYLENE, BUTYL METHOXYDIBENZOYLMETHANE | Guangzhou Tata Biotechnology Co., Ltd. | 0f8e08bf-4b14-bdad-e063-6394a90a34e1 | 2025-12-22 | Warnings | M020 |
| SUNSCREEN LIP PROTECTIONBROAD SPECTRUM SPF 15 | ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE | Guangzhou Tata Biotechnology Co., Ltd. | 1c32b019-a038-eb61-e063-6394a90a45f2 | 2025-12-22 | Warnings | M020 |
| SPF 50 MINERAL SUNSCREEN LIP | ZINC OXIDE , TITANIUM DIOXIDE | Guangzhou Tata Biotechnology Co., Ltd. | 1c6f0964-9bee-1c06-e063-6294a90ac2a4 | 2025-12-22 | Warnings | M020 |
| Absolut Skin SPF 50 Moisturizing Sunscreen | ETHYLHEXYL METHOXYCINNAMATE,ETHYLHEXYL SALICYLATE,METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL,OCTOCRYLENE | Guangzhou Tata Biotechnology Co., Ltd. | 3264543c-e8f5-da9a-e063-6394a90ac8c6 | 2025-12-22 | Warnings | M020 |
| Firmarine Moisturizer SPF 30 | AVOBENZONE, OCTINOXATE, AND OCTISALATE | Erno Laszlo, Inc. | 073f8b95-6f46-4341-817f-22f5b4f32542 | 2025-12-22 | Warnings | M020 |
| G.M. Collin FPS-SPF 50 UVA-UVB TINTED SUNSCREEN | ZINC OXIDE, TITANIUM DIOXIDE | LABORATOIRES DERMO-COSMETIK INC. | 468c90d7-3b9e-1641-e063-6394a90a928c | 2025-12-22 | Warnings | M020 |
| TiZO3 | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals Ltd. | 468d6476-127a-e9f0-e063-6294a90a3df9 | 2025-12-22 | Warnings | M020 |
| YOUR SKIN BUT BETTER FAIR | TITANIUM DIOXIDE AND ZINC OXIDE | IT COSMETICS, LLC | 3e65ec1a-0ed9-433d-8da9-a6cb61829911 | 2025-12-22 | Warnings | M020 |
| Sun Shades Sunscreen Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Melaleuca Inc. | 1f982f03-9542-29f9-e063-6294a90a959c | 2025-12-22 | Warnings | M020 |
| SOLARA SUNCARE - GLOW GETTER SPF-30 NATURALLY SCENTED | ZINC OXIDE | SOLARA SUNCARE, INC. | ca99b8c4-6778-43dc-bdd5-ca4a470860a0 | 2025-12-22 | Warnings | M020 |
| SOLARA SUNCARE - GO MINERAL DEFENSE SPORT SUPERFRUIT VITAMIN C PLUS ALOE SHEER SUNSCREEN MIST SPF-30 UNSCENTED | ZINC OXIDE | SOLARA SUNCARE, INC. | f810843b-5a4d-6cbc-e053-6294a90ac9e3 | 2025-12-22 | Warnings | M020 |
| SOLARA SUNCARE - CLEAN FREAK SPF-30 NATURALLY SCENTED | ZINC OXIDE | SOLARA SUNCARE, INC. | 7a5644b9-4368-4e9a-aa22-b3307acf43cc | 2025-12-22 | Warnings | M020 |
| MINERAL DEFENSE SPORT CERAMIDE SPF-30 | ZINC OXIDE | SOLARA SUNCARE, INC. | cbf9c715-2d45-4c1b-b58f-42795722821c | 2025-12-22 | Warnings | M020 |
| SPF 50 Baby Sunscreen Equate | AVOBENZONE, HOMOSALATE, OCTOCRYLENE | Walmart Inc | 4690d89b-ae61-2ed5-e063-6294a90a743f | 2025-12-22 | 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 |