Otc - Active Ingredient
Zinc Oxide 24.7% Purpose Sunscreen
(re) Setting 100% Mineral Powder Translucent Broad Spectrum Sunscreen Spf 35 Powder
FDA Label NDC 75936-169
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 Translucent Broad Spectrum Sunscreen Spf 35 (NDC 75936-169). 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
- Sunscreen
- 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 swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Stop use and ask a doctor if rash occurs.
Warnings
- For external use only.
- Do not use on damaged or broken skin.
- When using this products keep out of eyes. Rinse with water to remove.
Dosage & Administration
- 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 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 sunglassess
- Children under 6 months: Ask a doctor
Inactive Ingredient
Calcium Aluminum Borosilicate, Silica, Trimethylsiloxysilicate, Calcium Sodium Borosilicate, Polymethyl Methacrylate, Lauroyl Lysine, Polyglyceryl-10 Pentaisostearate, Boron Nitride, Triethoxycaprylysilane, Ethylhexylglycerin, Nylon-6/12, Sodium Dehydroacetate, Olive Glycerides, Ascorbyl Palmitate, Ceramide 3, Iron Oxides (CI 77492, 77491, 77499)
Package Label.Principal Display Panel
Supergoop!
(RE) SETTING
100% Mineral Powder
SPF 35
Translucent
Broad Spectrum Sunscreen SPF 35 PA+++
0.15 oz./4.25 g
* Please review the disclaimer below.
