TiZO2
- Product NDC
- 58892-336
- 11-digit product format
- 588920336
- Labeler code
- 58892
- Product ID
- 58892-336_509cad98-0322-2a0a-e063-6294a90a6ea9
- 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
- 2015-04-27
- Substance
- ZINC OXIDE; TITANIUM DIOXIDE
- Active strength
- 40.7; 85.4 mg/mL; mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 58892-336 | 58892-336-45 | D | Discontinued by firm | 2026-10-16 |
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 | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58892-336-45 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 58892-336-45 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 58892-336-45 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 58892-336-45 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 58892-336-45 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 58892-336-45 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 58892-336-45 | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 58892-336-45 | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 58892-336-45 | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 58892-336-45 | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 58892-336-45 | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 58892-336-50 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 58892-336-45 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 58892-336-50 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 58892-336-45 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 58892-336-50 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 58892-336-45 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 58892-336-50 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 58892-336-45 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 58892-336-45 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 58892-336-45 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 58892-336-45 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 58892-336-45 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 58892-336-45 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 58892-336-45 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | I | Inactivated by FDA | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 58892-336-45 | I | Inactivated by FDA | 110d247fa046… | a55b01930146… |
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
- TiZO2
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 40.7 mg/mL |
| TITANIUM DIOXIDE | 85.4 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
| 15FIX9V2JP | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 509cad98-0321-2a0a-e063-6294a90a6ea9 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Indexing SPL | Related label |
|---|---|---|---|
| 58892-336-45 | 2025-07-28 | 9855d018-e8c4-cd31-e053-dbdaa90ab51a | 30468afc-9616-4765-b046-12e97a0a7827 |
| 58892-336-50 | 2024-10-02 | 1030e365-59ef-111a-e063-dadaa90a10e2 | DRUG FACTS |
| 58892-336-50 | 2024-01-30 | 1030e365-59ef-111a-e063-dadaa90a10e2 | DRUG FACTS |
| 58892-336-45 | 2019-11-27 | 9855d018-e8c4-cd31-e053-dbdaa90ab51a | 30468afc-9616-4765-b046-12e97a0a7827 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58892-336-50 | TiZO2 | 50 mL in 1 TUBE | CREAM | 50 | 4 | |
| 58892-336-50 | TiZO2 | 1 in 1 CARTON | CREAM | 1 | 4 | |
| 58892-336-45 | TiZO2 | 44.4 mL in 1 TUBE | CREAM | 44.4 | 3 | |
| 58892-336-45 | TiZO2 | 1 in 1 CARTON | CREAM | 1 | 3 | |
| 58892-336-05 | TiZO2 | 5 mL in 1 TUBE | CREAM | 5 | 1 | |
| 58892-336-15 | TiZO2 | 1.5 mL in 1 PACKET | CREAM | 1.5 | 1 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58892-336 | TIZO2 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241004_43bec652-3f2c-4671-8a0c-c4c4a4bfcc7a.zip |
| 58892-336 | SOLAR PROTECTION FORMULA TIZO2 LIGHT SKIN FORMULA SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20121208_30468afc-9616-4765-b046-12e97a0a7827.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 |
|---|---|---|---|---|---|---|---|---|
| 58892-336-05 | 58892033605 | 5 mL in 1 TUBE (58892-336-05) | 5 ml | 2015-04-27 | No | No | Current | |
| 58892-336-15 | 58892033615 | 1.5 mL in 1 PACKET (58892-336-15) | 1.5 ml | 2015-04-27 | No | No | Current | |
| 58892-336-45 | 58892033645 | 44.4 mL in 1 TUBE | 44.4 ml | Historical | ||||
| 58892-336-50 | 58892033650 | 1 TUBE in 1 CARTON (58892-336-50) / 50 mL in 1 TUBE | 1 tube | 2015-04-27 | 0000-00-00 | No | No | Current |