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Badger Reformulating Sunscreens For Babies, Kids As Recall Unfolds

This article was originally published in The Tan Sheet

Executive Summary

Testing shows the products are contaminated with potentially infectious microorganisms: Pseudomonas aeruginosa, Candida parapsilosis and Acremonium fungi. Badger says it is moving to a different contract manufacturer “to eliminate any processing factors that may have contributed to this situation.”

W.S. Badger Co. Inc. says it is reformulating its Baby Sunscreen Lotion SPF 30 and Kids Sunscreen Lotion SPF 30 for improved shelf-life stability, following an announcement that the natural products firm is voluntarily recalling batches of the products due to contamination concerns.

The recall covers all lots of the sunscreen for babies and one lot of the product for kids, representing approximately 30,000 units in total, according to a Sept. 23 release. Testing has shown that the affected products are contaminated with potentially infectious microorganisms: Pseudomonas aeruginosa, Candida parapsilosis and Acremonium fungi.

The recalled sunscreens are sold in the U.S. and Canada online and through major retailers, independent co-ops and pharmacies, the firm says. No adverse reactions have been reported, but Badger is advising consumers not to use the products and either to contact the company or return the items to retailers for refunds.

Badger says it is investigating the contamination, but believes its sunscreen products were compromised due to “external factors during processing of select lots.” The firm said it is moving to a different contract manufacturer “to eliminate any processing factors that may have contributed to this situation.”

At the same time, the company is “rethinking” its preservative system and collaborating with expert chemists and microbiologists to strengthen the system for next year’s sunscreen season.

A full investigation of its sunscreen production procedures, quality-control mechanisms, ingredient sourcing and ingredient testing protocols is also under way, Badger says.

“As a father and grandfather, the safety and well-being of children is my highest priority,” Badger founder and CEO Bill Whyte states in the release, noting that the recall is the first in Badger’s 18-year history.

In a Sept. 25 email, Marketing Brand Manager Deirdre Fitzgerald said testing protocols under Badger’s quality-assurance program go “above and beyond what is required by FDA.”

In addition to subjecting products to full stability, shelf-life and microbial-challenge testing prior to market release, the firm tests individual lots for microbial contamination at production and in finished packaging, and retains samples from production runs that are tested regularly to ensure continued product purity, according to Fitzgerald.

“Because of these rigorous testing protocols, we were fortunate to learn of the contamination early with minimal product in the marketplace,” she said.

In the release, Whyte noted that recalled lots of sunscreen products passed Badger’s microbiological testing prior to sale. “It was during routine retesting that we discovered that the preservative system in several lots had been compromised,” he explains.

Firm “Rethinking” Preservative System

On its website, Gilsum, N.H.-based Badger touts Baby Sunscreen Lotion SPF 30 and Kids Sunscreen Lotion SPF 30 as offering “safe, chemical-free, broad-spectrum protection from UVA and UVB” via non-nanoform zinc oxide. The products – priced at $17.99 for 4 ounces – are certified by the Natural Products Association as 100% natural and by NSF International as 87% organic.

Badger prides itself on the “gentle” natural preservatives in its sunscreen formulations and the excellent safety ratings it has received from the Environmental Working Group, which evaluated 14 Badger formulas and awarded them scores of either 1 or 2 (low hazard) in its 2013 Sunscreen Guide (Also see "EWG Supports Nano-Engineered Mineral Sunscreens In 2013 Report" - Pink Sheet, 27 May, 2013.).

The firm says its baby and kids sunscreen lotions are primarily preserved with Leuconostoc ferment filtrate and gluconolactone, and the products’ 12% uncoated zinc oxide also contributes antimicrobial activity.

The efficacy of natural preservatives in cosmetics has come under question as industry works to meet rising demand for green formulations without compromising product safety.

For years, NGOs have called on manufacturers to reduce or discontinue their use of parabens, for example, as preservatives in personal care products. However, groups like the Competitive Enterprise Institute maintain that alternative preservatives are significantly less effective and eliminating parabens from formulas can actually increase consumers’ risk of experiencing adverse health effects due to contamination (Also see "“Extremist” Groups Needlessly Alarm Consumers About Cosmetics – Report" - HBW Insight, 24 Oct, 2011.).

[Editor’s note: This story was contributed by Elsevier Business Intelligence’s “The Rose Sheet,” your source for personal care product and cosmetics industry news. Call 1-800-332-2181 for a free trial – no credit card required.]

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