Indications and uses
Helps Prevent 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.
Tinted Mineral Sunscreen
- Manufacturer
- MADRE TIERRA, INC. | Custom Analytics LLC | Fragrance Manufacturing Inc. | Fallien Cosmeceuticals Ltd.
- Effective date
- 2025-12-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:25:41
Label at a glance#
ProductTinted Mineral Sunscreen
Active ingredientZINC OXIDE
Label structure9 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 inclu...
Label contents#
Full prescribing information#
Active Ingredients:
Zinc Oxide 20%
Purpose:
Sunscreen
Uses:
Helps Prevent 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 broken or damaged 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.
Warnings:
Keep out of reach of children
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:
Bismuth Oxychloride, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogen Dimethicone, Iron Oxides, Mica, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water
Other Information:
- Protect this product from excessive heat and direct sun
- May Stain Some fabrics
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0387122204609 | GTIN-13: 0387122204609 EAN-13: 0387122204609 GTIN-12: 387122204609 UPC-A: 387122204609 GTIN storage (14 digits): 00387122204609 | Madre 204.jpg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 87122-204-60 | Tinted Mineral Sunscreen | 60 g in 1 BOTTLE, PUMP | CREAM | 60 | 2 |
Products#
Every source-derived product name is available through these pages.
- Tinted Mineral Sunscreen
- Zinc Oxide
- DIMETHICONOL (2000 CST)
- MICA
- CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4)
- CYCLOPENTASILOXANE
- SODIUM CHLORIDE
- TRIETHOXYCAPRYLYLSILANE
- C12-15 ALKYL BENZOATE
- CYCLOHEXASILOXANE
- POLYSORBATE 20
- EDETATE DISODIUM ANHYDROUS
- DIMETHICONE
- CI 77492
- TETRAHEXYLDECYL ASCORBATE
- MICROCRYSTALLINE WAX
- POLYGLYCERYL-4 ISOSTEARATE
- GLYCERIN
- BISMUTH OXYCHLORIDE
- DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
- HYDROGEN DIMETHICONE (20 CST)
- PEG-10 DIMETHICONE (600 CST)
- CAPRYLYL GLYCOL
- DIMETHICONE CROSSPOLYMER
- CI 77499
- ALPHA-TOCOPHEROL ACETATE
- POLYHYDROXYSTEARIC ACID (2300 MW)
- CAPRYLHYDROXAMIC ACID
- PEG-30 DIPOLYHYDROXYSTEARATE
- STEARYL DIMETHICONE (400 MPA.S AT 50C)
- TRIETHANOLAMINE
- WATER
- CI 77491
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 87122-204 | 87122-204-60 |
| 58892-204 |
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 |
|---|---|---|---|---|---|---|
| Tinted Mineral Sunscreen | ZINC OXIDE | MADRE TIERRA, INC. | 3f697463-d3db-7b73-e063-6394a90ac222 | 2025-12-16 | Warnings | 87122-204-60 87122-204 87122020460 46150d11-6b94-5025-e063-6394a90a4238 3f697463-d3db-7b73-e063-6394a90ac222 |
| Proceuticals Private Label by TiZO tinted mineral sunscreen 20% zinc oxide | ZINC OXIDE | Fallien Cosmeceuticals, Ltd | 1dda8259-4121-3c76-e063-6394a90af189 | 2024-07-22 | Warnings | 58892-204 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.