Dermatone Sunscreen Spf 30
FDA Label NDC 65449-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Beaumont Products for the product Dermatone Sunscreen Spf 30 (NDC 65449-001). 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 ingredient, purpose, uses, warningfor external use only, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Avobenzone - 3.00%
Homosalate - 10.00%
Octisalate - 5.00%
Octocrylene - 10.00%

Purpose

Sunscreen

Uses

Uses • helps prevent sunburn • if used as directed with other sun protection mesures (see Direction) decreases the risk of skin cancer

Warningfor 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 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

Other Information

protect this product from excessive heat and direct sun

* Please review the disclaimer below.