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 |
|---|---|---|---|---|---|---|
| EltaMD UV Clear Tinted SPF46 | ZINC OXIDE AND OCTINOXATE SUNSCREEN | CP Skin Health Group, Inc. | 1ac59ef1-113e-4ad1-90c3-38353bc7e1ec | 2025-03-31 | Warnings | M020 |
| lip balm SPF15( CB222) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 316416d0-52b5-6f2f-e063-6294a90a9bc1 | 2025-03-28 | Warnings | M020 |
| lip balm SPF15( CB400) 01 | OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 316463e0-dc1f-e2ae-e063-6394a90a0c3c | 2025-03-28 | Warnings | M020 |
| Sunscreen Stick SPF30( CB400) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 316498d9-32fe-f884-e063-6394a90a4307 | 2025-03-28 | Warnings | M020 |
| ALEX MD PHD Sheer Mineral Sunscreen | ZINC OXIDE, TITANIUM DIOXIDE | PHYSICIAN LABORATORIES INC | 8f64c4fa-92ee-4af0-ab1b-6c3673f9a622 | 2025-03-28 | Warnings | M020 |
| ALEX MD PHD Tinted Mineral Sunscreen | ZINC OXIDE, TITANIUM DIOXIDE | PHYSICIAN LABORATORIES INC | 93873c34-5c72-43c8-b6c2-c65b596191d7 | 2025-03-28 | Warnings | M020 |
| TRADER JOES SHIMMER GLOW SUNSCREEN SPF 40 | AVOBENZONE, OCTISALATE, OCTOCRYLENE | Trader Joe's Company | 316c7793-5937-9ce4-e063-6294a90ae0a1 | 2025-03-28 | Warnings | M020 |
| CeraVe AM Facial Moisturizing Broad Spectrum SPF 50 Sunscreen | HOMOSALATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDE | L'Oreal USA Products Inc | dc85cff3-df18-4bb7-8d71-bb0878959fe2 | 2025-03-28 | Warnings | M020 |
| City Skin Age Defense Broad Spectrum SPF 50 | TITANIUM DIOXIDE AND ZINC OXIDE | Murad, LLC | f8c572a2-b4bc-49e9-95df-359f05bd69b7 | 2025-03-28 | Warnings | M020 |
| HEB SPF 50 Rejuvenate Sunscreen with Moisturizing Oils and Vitamins Continuous Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | H.E.B | 314c54ed-32f8-5c20-e063-6394a90a0af5 | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( blueberry) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 314f8990-4b33-e2b1-e063-6394a90a4d79 | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( bubble gum) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 31507a62-09a7-6bcc-e063-6394a90aa575 | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( Birthday cake) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 3152bd5d-474f-e392-e063-6294a90aa930 | 2025-03-27 | Warnings | M020 |
| Lip Balm SPF15 Bubble Gum Flavored | LIP BALM SPF15 BUBBLE GUM FLAVORED | LS Promotions Inc | 3152bd5d-4750-e392-e063-6294a90aa930 | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( Cocount Pina Colada) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 31538f32-9f71-bd40-e063-6394a90a1cd8 | 2025-03-27 | Warnings | M020 |
| Lip Balm SPF15 Birthday Cake flavored | LIP BALM SPF15 BIRTHDAY CAKE FLAVORED | LS Promotions Inc | 3153bc6a-8f60-ea37-e063-6294a90acd97 | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( Apple pie) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 3153e1fe-1c43-def0-e063-6294a90a6b3a | 2025-03-27 | Warnings | M020 |
| Lip Balm SPF15 Strawberry Shortcake flavored | LIP BALM SPF15 STRAWBERRY SHORTCAKE FLAVORED | LS Promotions Inc | 315402e4-c1ec-150f-e063-6294a90ae29e | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( Vanilla) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 3154206c-00b3-e5e3-e063-6394a90afee8 | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( Passion Fruit) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 31544568-c556-72b2-e063-6294a90ace91 | 2025-03-27 | 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 |