(Glow)Setting 100% Mineral Powder
Zinc Oxide 2.4% Sunscreen
(glow)setting 100% Mineral Powder Spf 35
FDA Label NDC 75936-603
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 (glow)setting 100% Mineral Powder Spf 35 (NDC 75936-603). 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 (glow)setting 100% mineral powder, otc - purpose, otc - keep out of reach of children, indications & usage, dosage & administration, warnings, 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 sking 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
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 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 sunglasses
• Children under 6 months: Ask a doctor
Warnings
Warnings
- For external use only
- Do not use on damaged or broken skin
- Stop use and ask a doctor if rash occurs
- When using this product keep out of eyes
- Rinse with water to remove
Inactive Ingredient
Inactive Ingredients
Synthetic Fluorphlogopite, Silica, Trimethylsiloxysilicate, Calcium Aluminum Borosilicate, Polymethyl Methacrylate, Calcium Sodium Borosilicate, Boron Nitride, Polyglyceryl-10 Pentaisostearate, Lauroyl Lysine, Triethoxycaprylylsilane, Ethylhexylglycerin, Water (Aqua), Nylon-12, Propanediol, Sodium Dehydroacetate, Oryza Sativa (Rice) Bran Extract, Aletris Farinosa Root Extract, Ascorbyl Palmitate, Helianthus Annuus (Sunflower) Seed Extract, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Titanium Dioxide (Cl 77891), Iron Oxides (Cl 77492, 77491, 77499)
Package Label.Principal Display Panel
(Glow)Setting 100% Mineral Powder
SPF 35
Broad Spectrum Sunscreen
0.13 oz. / 3.7 g.
* Please review the disclaimer below.
