Otc - Active Ingredient
Active Ingredients Purpose
Titanium Dioxide 1.3% Sunscreen
Zinc Oxide 17.4% Sunscreen
Mineral Mattescreen Spf 40 Cream
FDA Label NDC 75936-281
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Supergoop, Llc for the product Mineral Mattescreen Spf 40 (NDC 75936-281). 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, indications & usage, 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 measures (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
Indications & Usage
- Stop use and ask a doctor if rash occurs.
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.
Dosage & Administration
Directions
- Apply generously and evenly 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 sunscreen with a Broad-Spectrum SPF value of 15 or higher and other sunprotection measures including: • limit your time in the sun, especially from 10a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses
- Children under 6 months of age: ask a doctor.
Inactive Ingredient
Inactive Ingredients
Dimethicone, Dimethicone Copolymer, Caprylic/Capric Triglyceride, Methyl Dihydroabietate, Polyhydroxystearic Acid, C9-12 Alkane, Glycerin, Iron Oxides (CI 77492), Ethylhexylglycerin, Water (Aqua), Coco-Caprylate/Caprate, Silica, Stearic Acid, Iron Oxides (CI 77491), Iron Oxides (CI 77499), Hedychium Coronarium Root Extract, Lactobacillus/Arundinaria Gigantea Leaf Ferment Filtrate, Leuconostoc/Radish Root Ferment Filtrate, Titanium Dioxide (CI 77891)
Package Label.Principal Display Panel
Mineral Mattescreen SPF 40
100% Mineral Broad Spectrum Sunscreen SPF 40 PA +++
1.5 fl. oz./45 ml
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