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 |
|---|---|---|---|---|---|---|
| MISSHA M Perfect Cover BB Cream SPF42 (No. 25) | ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE | Able C&C Co., Ltd. | 604e7a49-7986-11ee-e053-2a91aa0a1bee | 2024-12-05 | Warnings | M020 |
| MISSHA M Perfect Cover BB No 27 | ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE | Able C&C Co., Ltd. | c4e16cec-c7db-4e5e-9d05-5d7afdb79091 | 2024-12-05 | Warnings | M020 |
| MISSHA M Perfect Cover BB SPF42 No29 | OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE | Able C&C Co., Ltd. | 3fc90114-4cdf-273e-e054-00144ff8d46c | 2024-12-05 | Warnings | M020 |
| MISSHA M Perfect Cover BB No 31 | ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE | Able C&C Co., Ltd. | 95862d15-d977-7276-e053-2995a90ab690 | 2024-12-05 | Warnings | M020 |
| MISSHA M Perfect Cover BB Cream SPF42 No. 25 | ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE | Able C&C Co., Ltd. | 9c6f48b1-007b-434f-b756-242e3390e9b7 | 2024-12-05 | Warnings | M020 |
| MISSHA ALL AROUND VITA C SUNSCREEN | ZINC OXIDE, HOMOSALATE, ETHYLHEXYL SALICYLATE, TITANIUM DIOXIDE | Able C&C Co., Ltd. | 1a7ec673-328a-8924-e063-6294a90a2f3d | 2024-12-05 | Warnings | M020 |
| (Re)Setting Refreshing Mist SPF 40 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Supergoop, LLC | d4d8f28d-cb00-298d-e053-2995a90a10eb | 2024-12-05 | Warnings | M020 |
| KEYS SOULCARE DAILY MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREEN | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc | 2ba71f81-54d0-4955-9bae-2b6e35c9c35f | 2024-12-05 | Warnings | M020 |
| Cay Skin Isle Glow Body SPF 45 | AVOBENZONE, OCTISALATE, OCTOCRYLENE | Cay Skin, Inc. | db5f6bad-65ae-2b05-e053-2a95a90a8569 | 2024-12-05 | Warnings | M020 |
| Cay Skin Isle Glow Face SPF 45 | AVOBENZONE, OCTISALATE, OCTOCRYLENE | Cay Skin, Inc. | d91bba06-fd9b-3eb5-e053-2995a90a6124 | 2024-12-05 | Warnings | M020 |
| Whoa Glow broad spectrum spf 30 sunscreen Sheer Bronze shimmer | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc | 65de9491-8804-4e3b-90a7-9b253e34b7d3 | 2024-12-05 | Warnings | M020 |
| Whoa Glow broad spectrum spf 30 sunscreen Sheer Champagne shimmer sunlight | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc | 499e5352-fcc4-4434-96f2-4375816991c9 | 2024-12-05 | Warnings | M020 |
| Cay Skin Isle Sheen Sunstick SPF 35 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Cay Skin, Inc. | 288c3aeb-01b2-ce39-e063-6394a90ad04a | 2024-12-05 | Warnings | M020 |
| Cay Skin MoBay Mineral Sunscreen Drops SPF 30 | ZINC OXIDE | Cay Skin, Inc. | 288d5456-98f3-a998-e063-6294a90a8366 | 2024-12-05 | Warnings | M020 |
| Solar Moisturizer SPF 30 | OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE | Allure Labs, LLC | ef4d54bf-25f5-4261-9d3d-c42b0d892275 | 2024-12-05 | Warnings | M020 |
| Clear Clear Zinc Solar Protection SPF 30 | ZINC OXIDE | Allure Labs, LLC | 79a3c8e2-c4f2-4c00-8e94-494654ae91a2 | 2024-12-05 | Warnings | M020 |
| LAB SERIES DAY RESCUE DEFENSE BROAD SPECTRUM SPF 35 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OXYBENZONE | Aramis Inc. | 8b206b6d-92e4-48bc-a40c-93ffdd635535 | 2024-12-05 | Warnings | M020 |
| Kids Broad Spectrum SPF 35 | ZINC OXIDE | Allure Labs, LLC | b72caf9b-46df-f30c-e053-2995a90a9b6d | 2024-12-05 | Warnings | M020 |
| CBD Blue Light Defense SPF 30 | ZINC OXIDE | Allure Labs | b63b99af-2ddb-3535-e053-2a95a90a65d5 | 2024-12-05 | Warnings | M020 |
| AHAVA CC SPF 30 | AVOBENZONE, ENSULIZOLE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | AHAVA - Dead Sea Laboratories Ltd | 2fa6249a-9614-455c-8e07-9b829f3b0c22 | 2024-12-04 | 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 |