Otc - Active Ingredient
Active Ingredients Purpose
Zinc Oxide 24.7% Sunscreen
(re) Setting 100% Mineral Powder Deep Broad Spectrum Spf 35 Powder
FDA Label NDC 75936-168
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 (re) Setting 100% Mineral Powder Deep Broad Spectrum Spf 35 (NDC 75936-168). 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 oher 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 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
- Use a water-resistant sunscreen if swimming or sweating
- Reapply at least every 2 hours
- Sun Protection Measures Spending time in the sun increases your risk of
- Children under 6 months of age: ask a doctor.
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 your time in the sun, especially from 10
a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses •
Inactive Ingredient
Inactive Ingredients
Calcium Aluminum Borosilicate, Silica, Trimethylsiloxysilicate, Calcium Sodium Borosilicate, Polymethyl Methacrylate, Lauroyl Lysine, Polyglyceryl-10 Pentaisostearate, Boron Nitride, Triethoxycaprylylsilane, Ethylhexylglycerin, Nylon-6/12, Sodium Dehydroacetate, Olive Glycerides, Ascorbyl Palmitate, Ceramide 3, Iron Oxides (CI 77492, CI 77491, CI 77499)
Package Label.Principal Display Panel
(RE) Setting 100% Mineral Powder SPF 35 PA +++
0.12 oz/ 4.25 g
* Please review the disclaimer below.
