Labeling Claims

By: David C. Steinberg, Steinberg & Associates

Posted: July 30, 2009, from the August 2009 issue of Cosmetics & Toiletries.

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The number of sunscreens that actually used PABA, or Aminobenzoic acid (the correct US drug name), were few since it was a poor sunscreen active that was too water-soluble and oil-insoluble; it also stained fabrics and required application at least 30 min before sun exposure to work. On the positive side, it is found in nature—Health Canada still lists it as a permitted natural health product active—and for about 25 years, it was the only UV filter universally allowed.

The sunscreen used at that time had an INCI designation of Octyl Dimethyl PABA (drug name: Padimate O; current INCI: Ethylhexyl Dimethyl PABA). When the first US sunscreen rules were published in 1978, this was the most popular UV filter in use. Marketers were allowed to claim that products containing octyl dimethyl PABA contained PABA, although these are different chemicals. The biblical saying, “People who live by the sword, die by the sword,” came true when marketers of the potential competition for Padimate O, octyl methoxycinnamate (OMC; drug name: Octinoxate; current INCI: Ethylhexyl Methoxycinnamate), began claiming PABA-free on product labels, inferring that something was wrong with PABA. This carried over to Padimate O and led to a domination of the sunscreen market by OMC, as well as the near disappearance of Padimate O from the market.

The labeling of sunscreens as PABA-free became almost automatic and the FDA addressed this in its 1993 proposed rules stating that PABA is not the correct ingredient name.³ In addition, the FDA noted that PABA was a safe and effective Category I sunscreen; however, the PABA-free labeling still inferred it was not. In the 1999 Final Monograph, the FDA allowed the claim for Aminobenzoic acid (PABA)-free but as of yet, to this author’s knowledge, no sunscreens have been marked with this claim.

Since the PABA-free claim worked, marketers began using other negative claims: oil-free, silicone-free, fragrance-free, chemical-free, phthalate-free, preservative-free, and the latest, paraben-free. Marketing would probably claim uranium-free or even battery-acid free if they thought it would sell products. The mentality is always the same: our products are safer than our competitors’, which contain “unsafe” ingredients.

With each new free-from claim, consumer press started to ask questions: How many people were killed or injured until this dangerous ingredient was removed? What other dangerous ingredients are being used that have not been disclosed yet? Shouldn’t the FDA pre-approve all cosmetic ingredients since so many are dangerous? This is why nongovernmental organizations (NGOs) call for more and stricter regulations on cosmetics and their ingredients. Why doesn’t the Personal Care Products Council add a requirement to its Consumer Commitment Code that cosmetic companies refrain from this practice of free-from marketing?