TiZO Photoceutical AM Replenish - Tinted
- Product NDC
- 58892-101
- 11-digit product format
- 588920101
- Labeler code
- 58892
- Product ID
- 58892-101_26bde5bd-1ffa-91f1-e063-6294a90adaf6
- 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
- 2015-10-13
- Substance
- ZINC OXIDE
- Active strength
- 160 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 Photoceutical AM Replenish - Tinted
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 160 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| fbafa468-fce0-4597-bcb0-a816dc71ec7c | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58892-101-50 | TiZO Photoceutical AM Replenish - Tinted | 1 in 1 CARTON | CREAM | 1 | 3 | |
| 58892-101-50 | TiZO Photoceutical AM Replenish - Tinted | 50 g in 1 TUBE | CREAM | 50 | 3 | |
| 58892-101-05 | TiZO Photoceutical AM Replenish - Tinted | 5 g in 1 TUBE | CREAM | 5 | 1 | |
| 58892-101-15 | TiZO Photoceutical AM Replenish - Tinted | 1.5 g in 1 PACKET | CREAM | 1.5 | 1 | |
| 58892-101-30 | TIZO PHOTOCEUTICAL AM REPLENISH - TINTED | 30 g in 1 TUBE | CREAM | 30 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58892-101 | TIZO PHOTOCEUTICAL AM REPLENISH - TINTED (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241115_fbafa468-fce0-4597-bcb0-a816dc71ec7c.zip |
| 58892-101 | TIZO PHOTOCEUTICAL AM REPLENISH - TINTED (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD] | 1 | Current NDC, Legacy NDC, 1 package rows | 20250212_2cc73c4f-30ea-0a51-e063-6394a90ac9a4.zip |
| 58892-101 | TIZO PHOTOCEUTICAL AM REPLENISH - TINTED (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD] | 1 | Current NDC, Legacy NDC, 1 package rows | 20250212_2cc84aba-006b-a78e-e063-6294a90ae040.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 |
|---|---|---|---|---|---|---|
| Banana Boat Ultra Sport Sunscreen Broad Spectrum SPF 15 | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands, LLC | 9751a700-5d51-357b-e053-2a95a90af66c | 2024-10-27 | Warnings | M020 |
| Banana Boat Sport Ultra Face SPF30 | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | dc757b03-7e7d-b362-e053-2a95a90a8446 | 2024-10-27 | Warnings | M020 |
| Banana Boat Kids Mineral Protection SPF50 | TITANIUM DIOXIDE,ZINC OXIDE | Edgewell Personal Care Brands LLC | dc7701b5-0c73-b4df-e053-2a95a90a0f1b | 2024-10-27 | Warnings | M020 |
| Banana Boat Mineral Sensitive SPF 50 | TITANIUM DIOXIDE, ZINC OXIDE | Edgewell Personal Care Brands LLC | dc7913d5-58f2-3077-e053-2a95a90a1627 | 2024-10-27 | Warnings | M020 |
| BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BORAD SPECTRUM SPF 30 | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | e5f9d56d-a80e-221c-e053-2a95a90aae92 | 2024-10-27 | Warnings | M020 |
| Banana Boat Mineral Sensitive Face SPF50 | TITANIUM DIOXIDE, ZINC OXIDE | Edgewell Personal Care Brands LLC | dc783438-b28f-b7f4-e053-2a95a90a3d65 | 2024-10-27 | Warnings | M020 |
| BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BORAD SPECTRUM SPF 30 | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | e53509bf-6bb7-2db7-e053-2a95a90aae18 | 2024-10-27 | Warnings | M020 |
| Banana Boat Sport Mineral SPF 50 | TITANIUM DIOXIDE, ZINC OXIDE | Edgewell Personal Care Brands LLC | dc79790f-e2bc-5414-e053-2a95a90a9e7a | 2024-10-27 | Warnings | M020 |
| TiZO Mineral Stick - Tinted SPF 45 | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals, LTD | fd6d0080-0bef-4e7e-8ca5-b859639efd0c | 2024-10-25 | Warnings | M020 |
| Alumier MD Post Procedure Kit with Hydrocortisone | TITANIUM DIOXIDE, ZINC OXIDE, HYDROCORTISONE | Alumier Labs | 2551d748-c3d6-cd18-e063-6294a90adab6 | 2024-10-25 | Warnings | M020 |
| TiZO Mineral Stick Non-Tinted SPF 45 | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals, LTD | e7044f18-992a-4f60-9a2b-f11ed06db09b | 2024-10-25 | Warnings | M020 |
| CoTZ Lip Balm | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals, LTD | 479a7d82-a068-4c2e-b50b-555c40e13e37 | 2024-10-25 | Warnings | M020 |
| TiZO Mineral Sun Defense SPF 50 | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals Ltd. | e17a8c35-2d49-4c99-b154-ea673c14753e | 2024-10-25 | Warnings | M020 |
| IPKN Moist and Firm Beauty Balm Light Medium | TITANIUM DIOXIDE | Inel Cosmetics Co., Ltd. | 1af6184e-3dc4-4eb3-8d51-aca724473451 | 2024-10-25 | Warnings | M020 |
| IPKN Moist and Firm Beauty Balm Light | TITANIUM DIOXIDE | Inel Cosmetics Co., Ltd. | 77d77838-aa13-4939-a1a0-50189fbb3fe0 | 2024-10-25 | Warnings | M020 |
| Dove Men plus Care Hydrate Face | AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE | CONOPCO Inc. d/b/a Unilever | afe75aff-c056-eaf7-e053-2a95a90af71b | 2024-10-24 | Warnings | M020 |
| Cancer Council Mineral Fluid SPF50 | ZINC OXIDE | Vitality US Co. | 1638f8a4-a2da-4e1f-e063-6294a90a03d9 | 2024-10-24 | Warnings | M020 |
| Marlowe SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Marlowe Holdings, LLC | f94bd91a-f0ab-680c-e053-6394a90ac855 | 2024-10-23 | Warnings | M020 |
| Vacation Broad Spectrum SPF 30 | HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE | Vacation Inc. | 2526eadf-4b55-ff81-e063-6394a90a3ba7 | 2024-10-23 | Warnings | M020 |
| Tenacious Ergodyne | KREWD CLEAR SPF 50 CONTINUOUS SPRAY | Tenacious Holdings, Inc. | 55d99d0a-dc7f-4915-b7c1-f999c8b36e0d | 2024-10-23 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58892-101-05 | 58892010105 | 5 g in 1 TUBE (58892-101-05) | 5 g | 2019-07-23 | Yes | No | Current | |
| 58892-101-15 | 58892010115 | 1.5 g in 1 PACKET (58892-101-15) | 1.5 g | 2019-07-23 | Yes | No | Current | |
| 58892-101-30 | 58892010130 | 30 g in 1 TUBE (58892-101-30) | 30 g | 2015-10-13 | No | No | Current | |
| 58892-101-50 | 58892010150 | 1 TUBE in 1 CARTON (58892-101-50) / 50 g in 1 TUBE | 1 tube | 2019-07-23 | 0000-00-00 | No | No | Current |