Our Commitment to Healthy Skin: Sunscreens
For more than 50 years, sunscreens in the U.S. have safely and effectively protected people from the harmful, cancer-causing effects of the sun.
Overview
In most countries, sunscreens are considered cosmetics, but in the U.S., sunscreens are regulated as over-the-counter (OTC) drugs by the U.S. Food and Drug Administration (FDA), requiring them to meet some of the same standards as other drug products. As an innovative industry, we have worked for decades with world-renowned scientists and thoughtful regulators to use modern, ethical, non-animal alternatives that ensure product safety, including working with the FDA through the regulatory process to provide consumers with a variety of safe, effective sunscreens that meet their needs.
PCPC and our member companies are committed to ensuring the safety and efficacy of sunscreens while also advocating for the ethical treatment of animals. We believe that mandating new animal tests is unnecessary given the fact that many of these products have been used for decades in addition to advances in non-animal testing methods to ensure product safety. Our member companies remain at the forefront in advocating globally for regulatory acceptance of cruelty-free testing and advancing innovation in sunscreen products for consumers.
Sunscreen Timeline
The FDA begins to regulate sunscreens as OTC drugs, initiating a comprehensive and lengthy review process.
Industry begins developing scientifically valid alternatives to animal testing with grant to establish the Johns Hopkins Center for Alternatives to Animal Testing (CAAT).
The last FDA approval of new sunscreen ingredients, limiting U.S. sunscreen manufacturers 16 UV filters, compared to Europe’s 36.
The Surgeon General’s Call to Action to Prevent Skin Cancer calls on partners in prevention from various sectors across the nation to address skin cancer as a major public health problem.
Congress passes the Sunscreen Innovation Act to expedite the FDA review and approval process for OTC sunscreens. Despite this, no new filters were approved.
PCPC presents on sunscreen formulation and the safety assessment framework at a public advisory panel convened by the FDA.
The FDA revises sunscreen active ingredient requirements and requests new safety data.
The FDA publishes Maximal Usage Trial (MUsT) data.
PCPC submits an initial work plan for the data request with the FDA.
Congress passes the CARES Act, which includes language to reform the rulemaking process for OTC drugs, changing the FDA monograph process to an Administrative Order.
PCPC submits human dermal studies to the FDA.
The FDA publishes the current requirements for marketing OTC sunscreen products and proposed requirements for the future.
Despite decades of safe use worldwide, the FDA mandates extensive new clinical (human dermal) and non-clinical (animal) testing for existing sunscreen ingredients.
PCPC member companies reiterate commitment to continue developing scientifically sound non-animal tests including using computer modeling and lab-grown cells.
PCPC and our member companies continue to stand for safety, science and a future free from animal testing, advocating for global acceptance of validated non-animal safety tests.
This year marks the 10-year anniversary of the Sunscreen Innovation Act; however, despite Congress passing the Act, the FDA has not approved any new filters since 1999.
