Coppertone ‘Assurance Assessment’ Anticipates Criticism From Sunscreen Reviews

Bayer shares results from a consulting firm's assessment of its operations, procedures and testing at the root of Coppertone SPF claims and other labeling aspects. The firm could get in front of a conversation that tends to arise this time of year regarding sunscreen safety, effectiveness and truthfulness in marketing.

Bayer AG gets in front of consumer advocacy groups' annual sunscreen product rankings and shopping recommendations with an independent review of label claims for its Coppertone line.

The German firm's US consumer health product business recently released a consultant's “assurance assessment” intended to bolster consumer confidence in Coppertone labeling, countering advocacy groups' criticism that the industry sees as often based on hazily defined testing approaches and contentious ingredient safety positions.

“Consumers are receiving information about sun protection from a variety of often contradictory sources, which is causing confusion. They want assurance that product performance claims are based on legitimate scientific testing,” said Michael Tune, vice president at Bayer consumer's personal care development center.

“As a leader in the US sun care industry, we wanted to utilize our long-standing leadership to meet the changing expectations of consumers by voluntarily conducting – and sharing – this independent assurance assessment,” he added in an April 24 release.

Bayer commissioned global consulting and standards firm AccountAbility to audit the firm’s internal processes, systems, controls, performance guidelines and associated data that inform its sunscreen labeling, focusing specifically on 10 top-selling Coppertone products in the US.

According to Eduardo Ruvolo, director of US and international medical affairs for sun and skin care products, the results show that Coppertone products “consistently and reliably provide the level of sun protection that our consumers expect and trust us to deliver.”

That aspect of the assessment could serve as a proactive defense against any pending allegations from Consumer Reports, which has issued findings over the past four years suggesting many sunscreen products on the US market do not deliver on their SPF promises. (Also see "PCPC Scorches Consumer Reports Test Methods In Assessing SPF Claims" - Pink Sheet, 25 May, 2015.)

While Coppertone Water Babies SPF 50 was among products that made the Consumers Reports' “recommended” list in 2016, industry generally has questioned Consumer Reports’ testing methods, and brands in past years have been compelled to retest products, verify challenged SPF claims and reassure their customer bases.

AccountAbility also deemed Coppertone compliant with FDA’s testing and labeling guidelines, as well as relevant international standards for product safety, efficacy and quality assurance, Bayer says.

The consulting firm reached its conclusions after reviewing the firm’s product development and manufacturing quality-assurance procedures in the US for the 2016 period, with access to Bayer/Coppertone facilities, records and personnel.

It specifically combed through documentation for 10 selected Coppertone spray, lotion and stick products, as well as the brand’s new “whipped” formulations. (Also see "Coppertone Innovates With Texture, Launching ‘Whipped’ Sunscreens" - HBW Insight, 7 Apr, 2017.)

The review considered data from the company’s final formulation testing – and the sun protection factor, water resistance, stability and broad-spectrum claims constructed around those test results – assessing against US and international standards.

AccountAbility also examined Bayer/Coppertone’s internal supplier audit processes and controls and performance metrics for third-party testing labs and contract manufacturing organizations, among other elements of its operations.

The consulting firm notes it did not test or re-test Coppertone sunscreen products.

However, “nothing has come to our attention that causes us to believe that Bayer has not [for the 2016 period] complied, in all material aspects, with its internal guidelines designed to ensure the quality, safety and efficacy of the products.”

Further, the company’s records overwhelmingly affirm that it “accurately tested and implemented quality assurance procedures, based on its reasonable interpretation of market regulation for the United States,” to ensure the accuracy of its labeling claims, AccountAbility says.

The firm notes that at the time of its report, Bayer, which acquired Coppertone in 2014, still was locating results from FDA-required critical wavelength testing conducted by the brand’s former owner, Merck & Co. Inc. The missing test results – to support broad-spectrum protection claims – pertain to a single selected “legacy” product sample, according to the report.

“Bayer’s archiving of testing results conducted by Merck is part of an on-going post-integration process. Once located, Bayer will formally archive the testing results in its central file depository system and, once provided, AccountAbility will update this report,” it says.

Among the firm’s recommendations for Bayer is “improving documentation references for easier access to records.”

EWG Score Not Likely To Improve

The independent assessment may not offer defense against another NGO report that tends to command significant consumer attention on an annual basis – the Environmental Working Group’s Guide to Sunscreens – which has included Coppertone products in previous years’ “worst” lists based on ingredient concerns that industry says are unwarranted and labeling practices permitted by FDA.

Overall, EWG rates the Coppertone brand a 3-10 (moderate to high hazard) on its Skin Deep scale.

Coppertone's recently launched Whipped sunscreens, including Clearly Sheet, were included in AccountAbility's audit of internal processes, systems, controls, performance guidelines and associated data that inform Bayer's sunscreen labeling.

Specifically, EWG has faulted the brand for using oxybenzone, which it links to hormonal effects and sensitization risks, and antioxidant retinyl palmitate, which the group maintains can have carcinogenic effects when exposed to sunlight. Industry refutes such assertions based on the bulk of available scientific evidence.

Moreover, EWG marks down Coppertone for labeling sunscreen products with SPFs higher than 50.

FDA is examining whether to cap SPF values at 50+ due to concerns that high-SPF products may give consumers an inflated sense of confidence that is not proportionate to the incremental clinical benefit that such offerings provide. However, industry members have contested those assumptions, and the agency is still considering stakeholder comments on what currently is only a proposed rule. (Also see "FDA Considers Capping SPF Values At 50+ Despite Efficacy Data" - Pink Sheet, 20 Jun, 2011.)

Even if the AccountAbility report doesn’t earn Coppertone points with EWG in those departments, the investment could prove a savvy one, serving as an authoritative marketing asset and a ready exhibit for the brand to point to if it comes under fire from detractors.

In the digital era, with a growing premium on consumer trust, NSF International is looking to provide a similar independent vetting service to cosmetics firms concerned about “consumer assurance.” (Also see "NSF International Launches Cosmetic Verification Program For ‘Consumer Assurance’" - HBW Insight, 18 Apr, 2017.)

"Coppertone has continued its commitment to quality, excellence, innovation and truth in labeling, backed up by science, clinically relevant data and robust testing," Ruvolo asserts.

The company is touting the move as further transparency from the brand that first introduced US consumers to commercial sun-care products in the 1940s and went on to set the standard for SPF labeling.

From the editors of The Rose Sheet.