Otc - Active Ingredient
Active Ingredients Purpose
Titanium Dioxide 2% Sunscreen
Zinc Oxide 24% Sunscreen
Play Mineral Broad Spectrum Spf 50 Lotion
FDA Label NDC 75936-175
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 Play Mineral Broad Spectrum Spf 50 (NDC 75936-175). 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 liberally 15 minutes before sun exposure
Reapply:
- after 80 minutes of swimming or sweating
- Immediately after towel drying
- At least every 2 hours
- Limit time in the sun, especially from 10a.m. – 2p.m.
- Wear long-sleeve shirts, pants, hats, and sunglasses
- Children under 6 months: Ask a doctor
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 15 or higher and other sun protection measures including:
Inactive Ingredient
Inactive Ingredients
C9-12 Alkane, Caprylic/Capric Triglyceride, Cetyl Esters, Coco-Caprylate/Caprate, Haematococcus Pluvalis Extract, Helianthus Annuus (Sunflower) Seed Wax, Hydrogenated Rapeseed Oil, Hydrogenated Rapeseed Oil, Hydrolyzed Jojoba Esters, Isopropyl Palmitate, Jojoba Esters, Perilla Ocymoides (Perilla) Seed Oil, Polyhydroxystearic Acid, Punica Granatum (Pomegranate) Seed Oil, Sea Water, Silica, Stearic Acid, Water
Package Label.Principal Display Panel
Play 100% Mineral Lotion
with green Algae
Broad Spectrum Sunscreen SPF 50
Water Resistant (80 Minutes)
* Please review the disclaimer below.
