The Personal Care Products Council and Consumer Healthcare Products Association Submit Joint Comments to FDA on the Sunscreen Tentative Final Monograph


Lisa Powers, (202) 466-0489,
Mike Tringale, (202) 429-3520,

Washington, D.C. – The Personal Care Products Council (PCPC) and Consumer Healthcare Products Association (CHPA) submitted comments to the U.S. Food & Drug Administration (FDA) in response to the Sunscreen Tentative Final Monograph (TFM).

The industry organizations note sunscreens are important products that protect consumers from the harmful effects of ultra-violet (UV) radiation and, most importantly, play a critical role in the fight against skin cancer – the most common form of cancer in the United States. FDA recently said, “given the recognized public health benefits of sunscreen use, Americans should continue to use sunscreen with other sun protective measures as this important rulemaking effort moves forward.”

The comments submitted by PCPC and CHPA, together with their member companies, outlined suggestions to the TFM that will help the industry continue to formulate a broad range of innovative sunscreen products that help protect consumers from the harmful effects of the sun’s UV rays while accommodating their product preferences. The Executive Summary can be found here.

Industry is committed to continue working in partnership with FDA to develop a work-plan for identifying existing data and generating additional data to support the safety of sunscreen active ingredients. Ultimately, having a greater number of sunscreen filters allows manufacturers to formulate safe and effective products to meet the diverse needs of individuals and their families, while providing necessary protection against the damaging effects of the sun.

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Based in Washington, D.C., the Personal Care Products Council (PCPC) is the leading national trade association representing global cosmetics and personal care products companies. Founded in 1894, PCPC’s approximately 600 member companies manufacture, distribute and supply the vast majority of finished personal care products marketed in the U.S. As the makers of a diverse range of products millions of consumers rely on and trust every day – from sunscreens, toothpaste and shampoo to moisturizer, lipstick and fragrance – personal care products companies are global leaders committed to product safety, quality and innovation. For more information on cosmetics and personal care products, please visit

 The Consumer Healthcare Products Association (CHPA) is the 138-year-old national trade association representing the leading manufacturers and marketers of over-the-counter (OTC) medicines and dietary supplements. Every dollar spent by consumers on OTC medicines saves the U.S. healthcare system more than $7, contributing a total of $146 billion in savings each year. CHPA is committed to empowering self-care by preserving and expanding choice and availability of consumer healthcare products.


MYTH: European Cosmetics are Safer than those Manufactured in the U.S.

Lisa Powers
EVP, Public Affairs & Communications
Personal Care Products Council

In today’s media environment, where repeated misinformation and myths can start to become ‘reality,’ it’s important to step back and more deeply examine the facts. One example is the oft-cited myth that cosmetics and personal care products are more strictly regulated in the European Union (EU) than in the United States. In fact, however, the approach to regulating cosmetics in the EU and U.S. is fundamentally the same.

Cosmetics are widely considered to be very low-risk to consumers; consequently, neither the EU nor the U.S. require regulatory approval prior to marketing. Instead, both jurisdictions require manufacturers to substantiate the safety of their products and ingredients before offering them to consumers. Both systems also authorize regulatory bodies to ban or restrict the use of certain ingredients and to require warnings and instructions for use on product labels. Independent expert scientific bodies have been established in both the EU (Scientific Committee on Consumer Safety [SCCS]) and U.S. (Cosmetic Ingredient Review Expert Panel [CIR]) to review test data and provide opinions on the safety of cosmetics ingredients. Both jurisdictions also require substantiation of product claims.

One of the most commonly cited myths is that European products are safer because the EU has banned over 1,400 ingredients, while the U.S. has banned less than 20.  Close examination of the EU Annex II banned list, however, reveals the vast majority of those chemicals are not, have not, and never would have been, used in cosmetics in either the U.S. or in Europe. The EU banned list includes substances such as jet aircraft fuel, pesticides, barbiturate drugs, the cancer drug Methotrexate, antibiotics, arsenic, strychnine, cyanide, rat poison, and carbon monoxide. Clearly, these are not ingredients that would ever be used in a cosmetic.

All cosmetic ingredients undergo strict scientific safety assessments using internationally recognized methodologies, whether these ingredients are used in cosmetics sold in the U.S. or the EU. Consumers can be confident of the high levels of product safety and quality on both sides of the Atlantic.

For more information, please visit, where you can find science-based safety information about the ingredients used globally in cosmetics and personal care products.