Indications and uses
Helps prevents sunburn. If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.
TiZO Photoceutical AM Replenish - Tinted
- Manufacturer
- Fallien Cosmeceuticals, LTD | Custom Analytics LLC | Fragrance Manufacturing Inc. (FMI)
- Effective date
- 2024-11-12
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 00:37:16
Label at a glance#
ProductTiZO Photoceutical AM Replenish - Tinted
Active ingredientZINC OXIDE
Label structure10 sections
Dosage and administration
Apply liberally 15 minutes before sun exposure. Use a water resistant product if swimming or sweating. Reapply: At least every 2 hours Children under 6 months: Ask a doctor Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures includ...
Label contents#
Full prescribing information#
Active Ingredients:
Zinc Oxide 16%
Purpose:
Sunscreen
Uses:
Helps prevents sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings:
For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
Directions:
- Apply liberally 15 minutes before sun exposure.
- Use a water resistant product if swimming or sweating.
- Reapply:
- At least every 2 hours
- Children under 6 months: Ask a doctor
- Sun Protection Measures:Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 a.m. - 2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses
Inactive Ingredients:
Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide, Hydrogen Dimethicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Vinyl Dimethicone/Hydrogen Dimethicone Silsesquioxane Crosspolymer
Other Information:
- Protect this product from excessive heat and direct sun.
- May stain some fabrics.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
Principal Display Panel – Carton Label
AM
REPLENISH
Lightly Tinted
SPF 40
TIZO®
PHOTOCEUTICAL®
Enhances, protects &
neutralizes free radicals
Mineral Sunscreen
Ceramides
Antioxidants C & E
featuring
SKIN FIRM TECHNOLOGY®
Broad Spectrum SPF 40
Net Wt. 1.75 oz/50 g
Principal Display Panel – Tube Label
TIZO®
PHOTOCEUTICAL
AM
REPLENISH
Lightly Tinted
Mineral Sunscreen
Ceramides
Antioxidants C & E
featuring
SKIN FIRM TECHNOLOGY®
SPF 40
Broad Spectrum
1.75 Fl. Oz/50 mL
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 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- TiZO Photoceutical AM Replenish - Tinted
- Zinc Oxide
- MEDIUM-CHAIN TRIGLYCERIDES
- CERAMIDE NP
- CYCLOMETHICONE 6
- CYCLOMETHICONE 5
- DIMETHICONE 20
- DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)
- DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
- DIMETHICONOL (2000 CST)
- BROWN IRON OXIDE
- HYDROGEN DIMETHICONE (20 CST)
- PEG-10 DIMETHICONE (600 CST)
- POLYHYDROXYSTEARIC ACID (2300 MW)
- TETRAHEXYLDECYL ASCORBATE
- .ALPHA.-TOCOPHEROL ACETATE
- VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58892-101 | 58892-101-50 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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 |
|---|---|---|---|---|---|---|
| TIZO PHOTOCEUTICAL AM REPLENISH - TINTED | ZINC OXIDE | Fallien Cosmeceuticals, LTD | 4e7c4702-5707-6c3e-e063-6394a90a05fd | 2026-04-02 | Warnings | 58892-101 |
| TiZO Photoceutical AM Replenish - Tinted | ZINC OXIDE | Fallien Cosmeceuticals, LTD | 2cc73c4f-30ea-0a51-e063-6394a90ac9a4 | 2025-01-28 | Warnings | 58892-101 |
| TiZO Photoceutical AM Replenish - Tinted | ZINC OXIDE | Fallien Cosmeceuticals, LTD | 2cc84aba-006b-a78e-e063-6294a90ae040 | 2025-01-28 | Warnings | 58892-101 |
| TiZO Photoceutical AM Replenish - Tinted | ZINC OXIDE | Fallien Cosmeceuticals, LTD | fbafa468-fce0-4597-bcb0-a816dc71ec7c | 2024-11-12 | Warnings | 58892-101-50 58892-101 58892010150 26bde5bd-1ffa-91f1-e063-6294a90adaf6 fbafa468-fce0-4597-bcb0-a816dc71ec7c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.