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Pigmentation01:19

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The color of the skin is influenced by a number of pigments, including melanin, carotene, and hemoglobin. Recall that melanin is produced by cells called melanocytes, which are found scattered throughout the stratum basale of the epidermis. The melanin is transferred to the keratinocytes via melanosomes.
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The first thing a clinician sees is the skin, so the examination of the skin should be part of any thorough physical examination. Most skin disorders are relatively benign, but a few, including melanomas, can be fatal if untreated. A couple of the more noticeable disorders, albinism and vitiligo, affect the appearance of the skin and its accessory organs.
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Skin cancer is a type of cancer that occurs when there is an abnormal growth of skin cells, usually triggered by damage to the DNA within the skin cells. It is primarily caused by exposure to ultraviolet (UV) radiation from the sun or artificial sources like tanning beds. Skin cancer is the most common type of cancer worldwide, and its incidence continues to rise.
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The skin plays a crucial role in the synthesis of vitamin D, a vital nutrient for various physiological processes in the body. Vitamin D is unique because it can be synthesized in the skin through a series of chemical reactions triggered by exposure to ultraviolet B (UVB) radiation from sunlight.
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Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
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Mutations01:35

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Mutations are changes in the sequence of DNA. These changes can occur spontaneously or they can be induced by exposure to environmental factors. Mutations can be characterized in a number of different ways: whether and how they alter the amino acid sequence of the protein, whether they occur over a small or large area of DNA, and whether they occur in somatic cells or germline cells.
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Related Experiment Video

Updated: Oct 20, 2025

Studying Chronic Exposure of Mice to Ultraviolet B Radiation
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Attack on Sunscreens Continues.

Howard Epstein1

  • 1EMD Electronics, Surface Solutions, Philadelphia, PA, an affiliate of Merck KGaA, Darmstadt, Germany; howard.epstein@emdgroup.com.

Skinmed
|September 16, 2021
PubMed
Summary
This summary is machine-generated.

The CARES Act removed the FDA's 2019 deadline for sunscreen regulations. New rules under the CARES Act will allow sunscreens to be generally recognized as safe and effective (GRASE) if they meet FDA-defined conditions.

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Area of Science:

  • Regulatory Science
  • Pharmaceutical Policy
  • Public Health

Background:

  • The U.S. Food and Drug Administration (FDA) had a November 26, 2019 deadline for a final sunscreen monograph.
  • The Coronavirus Aid, Relief, and Economic Security (CARES) Act, enacted on March 27, 2020, altered this regulatory timeline.

Purpose of the Study:

  • To analyze the impact of the CARES Act on FDA sunscreen regulations.
  • To outline the new framework for over-the-counter (OTC) monograph drugs, including sunscreens.

Main Methods:

  • Review of legislative changes introduced by the CARES Act.
  • Analysis of the FDA's revised responsibilities and timelines for sunscreen GRASE (generally recognized as safe and effective) status.

Main Results:

  • The CARES Act eliminated the original November 2019 deadline for the final sunscreen monograph.
  • Sunscreens will be considered GRASE if they meet new FDA-defined conditions.
  • The FDA is mandated to propose revised GRASE requirements within 18 months and will sunset by FY2022.

Conclusions:

  • The CARES Act modernizes OTC drug regulation, impacting sunscreen approval processes.
  • New pathways for sunscreen GRASE status are established under the CARES Act.
  • The regulatory landscape for sunscreens has been significantly reshaped by recent legislation.