TiZO Ultra Zinc SPF 40 (Tinted)
- Product NDC
- 58892-319
- 11-digit product format
- 588920319
- Labeler code
- 58892
- Product ID
- 58892-319_25a288aa-1828-492a-e063-6294a90ae5c3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Zinc Oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Fallien Cosmeceuticals, LTD
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-01-15
- Substance
- ZINC OXIDE
- Active strength
- 200 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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
- TiZO Ultra Zinc SPF 40 (Tinted)
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 200 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 36efd48b-910e-4b61-9519-a6d5c7e9a7c3 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58892-319-01 | TiZO Ultra Zinc SPF 40 (Tinted) | 100 g in 1 TUBE | CREAM | 100 | 4 | |
| 58892-319-01 | TiZO Ultra Zinc SPF 40 (Tinted) | 1 in 1 CARTON | CREAM | 1 | 4 | |
| 58892-319-05 | TiZO Ultra Zinc SPF 40 (Tinted) | 5 g in 1 TUBE | CREAM | 5 | 1 | |
| 58892-319-15 | TiZO Ultra Zinc SPF 40 (Tinted) | 1.5 g in 1 PACKET | CREAM | 1.5 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58892-319 | TIZO ULTRA ZINC SPF 40 (TINTED) (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241031_36efd48b-910e-4b61-9519-a6d5c7e9a7c3.zip |
| 58892-319 | TIZO ULTRA ZINC SPF 40 (TINTED) (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.] | 1 | Current NDC, Legacy NDC, 1 package rows | 20250212_2d3faa43-0d78-58de-e063-6294a90a0b17.zip |
| 58892-319 | TIZO ULTRA ZINC SPF 40 (TINTED) (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD] | 1 | Current NDC, Legacy NDC, 1 package rows | 20250212_2d0856cf-d3da-5a77-e063-6294a90ad5b4.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 |
|---|---|---|---|---|---|---|
| Iris and Romeo Weekend Skin | ZINC OXIDE | Iris and Romeo | 0828a345-0178-1503-e063-6394a90a7d24 | 2025-10-31 | Warnings | M020 |
| Iris and Romeo Weekend Skin Bronze Glow | ZINC OXIDE | Iris and Romeo | 2abe1780-d1e6-a90a-e063-6294a90a64ee | 2025-10-31 | Warnings | M020 |
| Iris and Romeo Weekend Skin Warm Glow | ZINC OXIDE | Iris and Romeo | 0852977a-83e5-26cf-e063-6294a90ab3f9 | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Light 205 N | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 055878ef-c671-4d65-9639-bda5a1dc3029 | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Fair 120 N | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | b6b18a13-1f22-4061-91f5-852f7a487c03 | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Fair 100 W | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | d7815651-6b14-41f6-90cd-0a5b0b4a12ac | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Fair 140 W | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 59331429-5fe0-4671-aabd-ec20640dd3ee | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Fair 125 C | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | c6ef3b07-babf-401d-a241-4e81e162c965 | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Medium 330 W | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | c6d4b851-bf09-4177-b473-a2378c55ceec | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Light 210 N | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 2f151e6c-ab2d-40cb-a67c-e067147ed702 | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Light 280 N | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 6b0b9204-f205-415b-bd16-1970958b8be7 | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Light 240 W | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 8c12a34c-f648-4b55-8265-d430c72ae205 | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Light 250 W | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 0b1c20e6-9d98-4b69-8fe0-ac5e9f2b9b2c | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Medium 370 N | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | b8d4862e-2671-4b85-8338-f935e0d0194f | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Medium 310 C | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 8d53abee-73bc-4268-b08d-0c196ff4d852 | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Medium 375 N | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 1de296f5-276b-4e8f-8db2-78ea01965c4a | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Rich 610 N | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 75543b93-8ed9-4c7b-9fcf-99745df5a194 | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Rich 620 W | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 798eecb3-ff6e-46d1-9053-b40e9cd02e5c | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Rich 640 W | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | cbf949b3-e640-48eb-acf6-fccd6f258865 | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Rich 650 C | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | b8bfad36-54b7-42f3-bb5b-5eda1a10f021 | 2025-10-31 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58892-319-01 | 58892031901 | 1 TUBE in 1 CARTON (58892-319-01) / 100 g in 1 TUBE | 1 tube | 2022-03-15 | 0000-00-00 | No | No | Current |
| 58892-319-05 | 58892031905 | 5 g in 1 TUBE (58892-319-05) | 5 g | 2022-03-15 | Yes | No | Current | |
| 58892-319-15 | 58892031915 | 1.5 g in 1 PACKET (58892-319-15) | 1.5 g | 2022-03-15 | Yes | No | Current |