Poth Clear Gel Sunscreen Spf 50 Gel
FDA Label NDC 87669-963

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Poth Llc for the product Poth Clear Gel Sunscreen Spf 50 (NDC 87669-963). 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 drug facts, active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Avobenzone 3%
Homosalate 10%
Octisalate 5%
Octocrylene 10%

Purpose

Sunscreen

Uses

  • Help 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 and as needed.
  • Children under 6 months: ask a doctor.
  • 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 the risk, regularly use a sunscreen with broad spectrum of 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-sleeved shirts, pants, hats, and sunglasses

Other Information

  • Protect this product from high heat and direct sun.

Inactive Ingredients

Ascorbic Acid, Beeswax, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Ethyl Vanillin, Isododecane, Jojoba Esters, Lecithin, Meadowfoam Estolide, Microcrystalline Wax, Polyhydroxystearic Acid, Silica, Tocopherol, Tridecyl Salicylate, Zinc Sulfate

Questions?

1-201-677-8827 or www.pothskin.com/spf

* Please review the disclaimer below.