Active Ingredients
Avobenzone 3%
Octinoxate 7.50%
Octocrylene 10%
Pelotan Sunscreen Broad Spectrum Spf 30 Spray
FDA Label NDC 85962-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pelotan Llc for the product Pelotan Sunscreen Broad Spectrum Spf 30 (NDC 85962-001). 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 active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
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
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.
Stop Use And Ask A Doctor
if rash occurs
Keep Out Of Reach Of Children.
If product is swallowed, get medical help or contact a Poison Control Center right away.
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
- 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 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-sleeve shirts, pants, hats, and sunglasses
- Children under 6 months: Ask a doctor
Inactive Ingredients
Alcohol Denat., C12-15 Alkyl Benzoate, Propylene Glycol, Cyclopentasiloxane, Acrylates/Octylacrylamide Copolymer, Cyclohexasiloxane, Fragrance/Parfum, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Panthenol, Benzyl Benzoate, Benzyl Salicylate, Coumarin
Other Information
- Protect this product from excessive heat and direct sun
- Report serious adverse events to Pelotan LLC, 1007 N Orange St. 4th Floor, Wilmington, DE 19801
Questions Or Comments?
Visit www.pelotan.cc
Product Label
1 (Spray)
* Please review the disclaimer below.
