408 JOURNAL OF COSMETIC SCIENCE SUNSCREEN COMBINATION PRODUCTS - SENSE OR NONSENSE? Ken Klein Cosmetech Laboratories Inc., Fairfield, NJ The publication of each of the sunscreen monographs (Proposed in 1978, Tentative Final in 1993 and Final (sort off) in 1999) initiated an SPF race/marketing frenzy by almost every seller of sunscreen-finished goods. Generally they ignored the SPF maximums set by the agency and produced products with SPFs as high as 100! (If a person's MED is 20 minutes an SPF of 100 corresponds to approximately 33 hours of noonday sun.) Eventually marketers realized that just having another very high SPF wasn't really enough to entice/excite consumers. What we have now begun to see is the advent of combination sunscreen products. This paper will examine the claims, science, regulations and meaning of several combination sunscreen products including: Sunscreen/insect repellent Sunscreen/hydroquinone Sunscreen/AHA Sunscreen/Skin Protectant Sunscreen/moisturizer Sunscreen/DHA S unscreen/antiacne Sunscreen/anti-oxidant While some of these combinations are reasonable and provide a real consumer benefit, others are no more than marketing hype, designed to take advantage of consumer ignorance. In some cases the combination products crosses the paths of two FDA drug monographs while in others it involves two completely separate government agencies. The sunscreen/insect repe!lant combination is perhaps the most logical one that comes to mind and has been thought of, worked on and more recently marketed for more than 30 years. There are two major factors to be considered when developing this combination product: Regulatory considerations: two separate Governmental agencies (FDA and EPA) have rules that must be considered Technical considerations: will the sunscreen efficacy be inhibited by the presence by high concentrations of an outstanding solvent (Deet)? Will the performance of the Deet be affected by the sunscreen? Sunscreen/hydroquinone: This is a reasonable combination and has been used by companies for many years. Sunscreen/AHA: It is well known that the use of AHA products can increase a person's sensitivity to UV radiation. The FDA has conducted several studies that clearly show this correlation.

2001 ANNUAL SCIENTIFIC SEMINAR 409 Sunscreen/Skin Protectant: While this product crosses the lines of two FDA monographs, the FDA has said that this is a reasonable and proper combination product that has enjoyed popularity for many years. Sunscreen/Moisturizer: Many companies have marketed products of this type for several decades and consumers have come to almost expect sunscreen protection from their moisturizer products. Quite often the difficulty comes in as regards improper labeling of these products. When a cosmetic claim is made for a sunscreen product, combination drug and cosmetic labeling must be adhered to. The sunscreens must be listed separately using their drug designations and the other ingredients must be listed in decreasing order by % w/w using their INCI designations. How many of us have seen products of this type list the water as "purified water" i.e.: drug water? Which is clearly incorrect! Sunscreen/DHA: This combination product is a most interesting one. The FDA has said that if one used DHA and refers to "tanning", which of course has nothing at all to do with the action of DHA products, and does not incorporate a sunscreen or claim an SPF, then a warning statement must be displayed informing the consumer that "this product does not contain a sunscreen" and does not protect from the sun. This means that the FDA is now regulating the label of a cosmetic product and requiring a warning label because it does not contain a drug! While this seems silly at first glance, the FDA believes (and they are correct) that consumers who purchase DHA self "tanning" products expect that they will be protected (to some unknown extent) by having their skin "tanned" and this is essentially not true. Thus this cosmetic product makes an implied drug claim without having any drug action and would be mislabeled if it did not contain the warning statement. Sunscreen/Antiacne: There is much confusion regarding this combination product. Certainly, use of some antiacne drugs, such as tetracycline increases a person's sensitivity to UV in general and UVA in particular. However, there are some combinations that are questionable such as sunscreen and benzoyl peroxide. Sunscreen/Antioxidant: While it is commonly believed, with much supporting data, that antioxidants play a beneficial role in acting as free radical scavengers to protect the skin from the ravages of singlet oxygen, the FDA has not commented on whether this is a drug action. Keep in mind that something becomes a drug (according to the FDA) if it is intended to affect the structure or function of the body/skin or is to be used in the cure, diagnosis or mitigation of a disease. Based on this definition are antioxidants drugs? I for one hope, and think, not.