Max Mineral
- Manufacturer
- Peter Thomas Roth Labs, LLC | June Jacobs Labs, LLC
- Effective date
- 2023-11-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 00:01:59
Label at a glance#
ProductMax Mineral
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure9 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Titanium Dioxide I.93%
Zinc Oxide 19.24%
OTC - PURPOSE SECTION
Active Ingredients.............................................................. Purpose
Titanium Dioxide I.93%................................................... Sunscreen
Zinc Oxide 19.24%..... ................................................... Sunscreen
INDICATIONS & USAGE SECTION
Uses
helps prevent sunburn
lf used as directed with other sun protection measures
(see Directions), decreases the risk of skin cancer and early skinaging caused by the sun
DOSAGE & ADMINISTRATION SECTION
Directions
apply liberally 15 minutes before sun exposure
reapply at least every 2 hours
use a water•resistant sunscreen if swimming or sweating
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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. to 2 p.m.
wear long•sleeved shirts, pants, hats, and sunglasses
children under 6 months of age: ask a doctor
WARNINGS SECTION
Warnings
For external use only
Do not use on damaged or broken skin.
When using this product keep out of eyes. Rinse with water to remove.
Stop use and aska doctor if rash occurs.
Keep out of reach of children.
If product is swallowed, get medical help or contact a Poison Control Center right away.
INACTIVE INGREDIENT SECTION
Inactive Ingredients
Water, Butyloctyl Salicylate, C9- 12 Alkane, Carthamus Tinctorius (Safflower) Oleosomes, lsodecyl Neopentanoate, Dicaprylyl Carbonate, Cetyl Alcohol, Coco-Caprylate/ Caprate, Propanediol, Ethylhexyl Olivate, Glyceryl Stearate, PEG-I00 Stearate, Cetearyl Olivate, Stearyl Phosphate, Triethoxycaprylylsilane, Phenoxyethanol, Oleth•3 Phosphate, Sorbitan Olivate, HDI/Trimethylol Hexyllactone Crosspolymer, Alumina, Xanthan Gum, Polymethylsilsesquioxane, Polyhydroxystearic Acid, Squalane, Gluconolactone, Sodium Phytate, lsopropyl Titanium Triisostearate, Sodium Benzoate, Hydrogen Dimethicone, Potassium Sorbate, Silica, Tocopheryl Acetate, Ascorbic Acid, Diamond Powder, Iron Oxides, Mica
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
OTC - QUESTIONS SECTION
Question or comments?
Call toll free 1-800-PTR-SKIN (787-7546)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54031-020-01 | Max Mineral | 48.19 g in 1 TUBE | CREAM | 48.19 | 3 | |
| 54031-020-02 | Max Mineral | 48.19 g in 1 CARTON | CREAM | 48.19 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Max Mineral
- Titanium Dioxide, Zinc Oxide
- TRIETHOXYCAPRYLYLSILANE
- MICA
- C9-12 ALKANE
- CARTHAMUS TINCTORIUS SEED OLEOSOMES
- STEARYL PHOSPHATE
- SODIUM BENZOATE
- ZINC OXIDE
- ISOPROPYL TITANIUM TRIISOSTEARATE
- ISODECYL NEOPENTANOATE
- COCO-CAPRYLATE/CAPRATE
- GLYCERYL MONOSTEARATE
- CETYL ALCOHOL
- PHENOXYETHANOL
- HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER
- SILICON DIOXIDE
- DIAMOND
- PHYTATE SODIUM
- FERRIC OXIDE YELLOW
- POLYHYDROXYSTEARIC ACID (2300 MW)
- FERROSOFERRIC OXIDE
- .ALPHA.-TOCOPHEROL ACETATE
- XANTHAN GUM
- POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)
- FERRIC OXIDE RED
- POTASSIUM SORBATE
- ETHYLHEXYL OLIVATE
- OLETH-3 PHOSPHATE
- BUTYLOCTYL SALICYLATE
- DICAPRYLYL CARBONATE
- PEG-100 STEARATE
- CETEARYL OLIVATE
- TITANIUM DIOXIDE
- PROPANEDIOL
- WATER
- SORBITAN OLIVATE
- ALUMINUM OXIDE
- SQUALANE
- GLUCONOLACTONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54031-020 | 54031-020-01, 54031-020-02 |
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 |
|---|---|---|---|---|---|---|
| Max Mineral | TITANIUM DIOXIDE, ZINC OXIDE | Peter Thomas Roth Labs, LLC | 0980992c-6488-2fa1-e063-6294a90a41ea | 2023-11-14 | Warnings | 54031-020-02 54031-020-01 54031-020 54031002001 54031002002 0a2095ac-5703-39ba-e063-6294a90aa1c9 0980992c-6488-2fa1-e063-6294a90a41ea |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.