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
- 2027-12-31
- 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
- 2027-12-31
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 |
|---|---|---|---|---|---|---|
| Strawberry Limoncello SPF 15 Broad Spectrum Lip Balm | STRAWBERRY LIMONCELLO SPF 15 BROAD SPECTRUM LIP BALM | Raining Rose, Inc | c222bd6e-59b0-394a-e053-2995a90ae429 | 2023-10-18 | Warnings | M020 |
| Raspberry Lime Margarita SPF 15 Broad Spectrum Lip Balm | RASPBERRY LIME MARGARITA SPF 15 BROAD SPECTRUM LIP BALM | Raining Rose, Inc | c2150247-ff7d-9863-e053-2995a90a3f01 | 2023-10-18 | Warnings | M020 |
| Key Lime Pie Shake SPF 15 Broad Spectrum Lip Balm | KEY LIME PIE SHAKE SPF 15 BROAD SPECTRUM LIP BALM | Raining Rose, Inc | c214e5c2-53ea-31bd-e053-2995a90a886a | 2023-10-18 | Warnings | M020 |
| Summer Sangria SPF 15 Broad Spectrum Lip Balm | SUMMER SANGRIA SPF 15 BROAD SPECTRUM LIP BALM | Raining Rose, Inc | c222cc2d-232c-0f3d-e053-2995a90af79b | 2023-10-18 | Warnings | M020 |
| Broad Spectrum SPF 30 Mineral Sun Stick | BROAD SPECTRUM SPF 30 MINERAL SUN STICK | Raining Rose | c2261a55-12e4-9a75-e053-2a95a90a8211 | 2023-10-18 | Warnings | M020 |
| Broad Spectrum SPF 30 Sunscreen | BROAD SPECTRUM SPF 30 SUNSCREEN | Raining Rose | c238ce45-91d9-e9fa-e053-2a95a90a7d65 | 2023-10-18 | Warnings | M020 |
| Broad Spectrum SPF 30 Sunscreen | BROAD SPECTRUM SPF 30 SUNSCREEN | Raining Rose | c23d49bd-8447-4920-e053-2a95a90a0a06 | 2023-10-18 | Warnings | M020 |
| Tropical Mint Broad Spectrum SPF 15 Lip Moisturizer | TROPICAL MINT SPF 15 BROAD SPECTRUM LIP MOISTURIZER | Raining Rose, Inc | aef6b419-efac-4e37-e053-2995a90a0d2f | 2023-10-18 | Warnings | M020 |
| Broad Spectrum SPF 15 Sunscreen Cherry Lip Balm | BROAD SPECTRUM SPF 15 SUNSCREEN CHERRY LIP BALM | Raining Rose | efbd2179-5f6d-a8c6-e053-2a95a90a17e7 | 2023-10-18 | Warnings | M020 |
| Vanilla Mint Broad Spectrum SPF 15 Lip Moisturizer | VANILLA MINT SPF 15 BROAD SPECTRUM LIP MOISTURIZER | Raining Rose, Inc | af10a007-6597-2231-e053-2995a90a8717 | 2023-10-18 | Warnings | M020 |
| Mint Broad Spectrum SPF 15 Lip Moisturizer | MINT SPF 15 BROAD SPECTRUM LIP MOISTURIZER | Raining Rose, Inc | af471721-54e4-0738-e053-2a95a90a7e12 | 2023-10-18 | Warnings | M020 |
| Spearmint SPF 15 Broad Spectrum Lip Balm | SPEARMINT SPF 15 BROAD SPECTRUM LIP BALM | Raining Rose, Inc | a9029e6d-7443-efe2-e053-2995a90a8125 | 2023-10-18 | Warnings | M020 |
| Watermelon Twist SPF 15 Broad Spectrum Lip Balm | WATERMELON TWIST SPF 15 BROAD SPECTRUM LIP BALM | Raining Rose, Inc | a903a7cc-0de5-5adc-e053-2a95a90aa961 | 2023-10-18 | Warnings | M020 |
| Vanilla Mint SPF 15 Broad Spectrum Lip Balm | VANILLA MINT SPF 15 BROAD SPECTRUM LIP BALM | Raining Rose, Inc | a9031b15-d2b0-d248-e053-2a95a90a65ff | 2023-10-18 | Warnings | M020 |
| Cherry SPF 15 Broad Spectrum Lip Balm | CHERRY SPF 15 BROAD SPECTRUM LIP BALM | Raining Rose, Inc | a75a7326-aaa4-767b-e053-2995a90adf16 | 2023-10-18 | Warnings | M020 |
| Wildberry SPF 15 Broad Spectrum Lip Balm | WILDBERRY SPF 15 BROAD SPECTRUM LIP BALM | Raining Rose, Inc | a903c855-867b-4f14-e053-2a95a90a5333 | 2023-10-18 | Warnings | M020 |
| Tropical SPF 15 Broad Spectrum Lip Balm | TROPICAL SPF 15 BROAD SPECTRUM LIP BALM | Raining Rose, Inc | a903202b-1dc6-85ad-e053-2995a90a4ab8 | 2023-10-18 | Warnings | M020 |
| Pomegranate SPF 15 Broad Spectrum Lip Balm | POMEGRANATE SPF 15 BROAD SPECTRUM LIP BALM | Raining Rose, Inc | a901e45d-2ea6-bae8-e053-2a95a90afc98 | 2023-10-18 | Warnings | M020 |
| Vanilla SPF 15 Broad Spectrum Lip Balm | VANILLA SPF 15 BROAD SPECTRUM LIP BALM | Raining Rose, Inc | a903a7cc-0dd5-5adc-e053-2a95a90aa961 | 2023-10-18 | Warnings | M020 |
| Raspberry SPF 15 Broad Spectrum Lip Balm | RASPBERRY SPF 15 BROAD SPECTRUM LIP BALM | Raining Rose, Inc | a902917c-b8fb-b2d0-e053-2995a90a42db | 2023-10-18 | 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 |