Otc - Active Ingredient
Active ingredients Purpose
Zinc oxide 17% Sunscreen
Titanium dioxide 0.7% Sunscreen
Mineral Mattescreen Broad Spectrum Spf 40
FDA Label NDC 75936-280
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Taylor James for the product Mineral Mattescreen Broad Spectrum Spf 40 (NDC 75936-280). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
- Helps prevent Sunburn
- If used as directed with other sun protection ( see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Warnings
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 ask a doctor if rash occurs.
Dosage & Administration
Directions
- apply generously and evenly 15 minutes before sun exposure
- reapply:
- after 40 minutes of swimming or sweating
- immediately after towel drying
- at least 2 hours
- Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk of skin cancer and early skin aging, 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. -2p.m.
- Wear Long-sleeved shirts, pants, hats, and sunglasses
- Children under 6 months: Ask a doctor
Inactive Ingredient
Inactive ingredients
Cyclopentasiloxane, Coco-Caprylate, Isododecane, Coco-Caprylate/Caprate, Dimethicone Crosspolymer, Silica Dimethyl Silylate, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Argania Spinosa Kernel Oil, Cyclohexasiloxane, Tocopheryl Acetate, C12-15 Alkyl Benzoate, Polyglyceryl-3 Polyricinoleate, Dimethicone, Iron Oxides (CI 77492), Water (Aqua), Isostearic Acid, Cyclotetrasiloxane, Propanediol, Ethylhexylglycerin, PEG/PPG-18/18 Dimethicone, Bisabolol, Alumina, Hydrogen Dimethicone, Iron Oxides (CI 77491),
Polyhydroxystearic Acid, Iron Oxides (CI 77499), Buddleja Officinalis Flower Extract, Triethoxycaprylylsilance, Tocopherol, Phenoxyethanol, Potassium Sorbate, Hydrangea Aborescens Root Extract, Morus Alba Root Extract, Polysorbate 20, Resveratrol, Scutellaria Lateriflora Extract, Caprylyl Glycol, Hexylene Glycol, Pentapeptide-21
Package Label.Principal Display Panel
Smooth and Poreless
100% mineral Poreless
Broad Spectrum SPF 40
Water & Sweat Resistant (40 minutes)
1.5 fl. oz/ 45 mL
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