For makers of over-the-counter (OTC) products, business is very good these days. Some estimates suggest that the US OTC skincare segment may be worth as much as $12.3 billion, with projections that number will continue to grow to around $22.6 billion by 2028. And yet skincare is but a small part of the overall OTC market: more that 100,000 products currently sold in the US market contain one or more of over 1,000 distinct ingredients spanning more than 80 therapeutic categories.
If professional medical providers struggle to stay abreast of the latest developments in OTC products, imagine the confusion among consumers. The variety of products that lines pharmacy and big box shelves is simply dizzying, and this does not even account for the explosion in availability of these and more products through online purchasing. Moreover, companies that develop and sell OTC products are not beholden to the same standards with respect to safety and effectiveness claims as pharmacy brands, leading to sometimes unfortunate and speculative promises for better health, more vibrant skin, and anti-aging effects.
Instead, purveyors of OTC products are subject to a different set of pressures, including, but not limited to, consumer demand, market forces, and competition. Yet, while each of these may explain why some marketers rely on outlandish claims to drive sales, they can also have a positive impact on the kinds of products that filter through to consumers. Consider the veritable explosion in men’s skincare lines. About a decade ago, brands designed for and sold to men were almost non-existent, but by the year 2022, that segment of the market may be worth as much as $122 million annually. Innovation and portfolio expansion are thought to be key drivers behind continuous incremental annual growth.
Demand for men’s skincare products is echoed in other specialized segments, including products specifically designed for sensitive skin, skin of color, and others. And all of that may be very good news for consumers, as the growing array of products will better reflect the diversity of skincare needs inherent to the multicultural US population.
The intense competition among OTC brands might also have a more direct impact on the products consumers purchase and use. Competition among major brands has fostered a race to improve ingredient science, because, ultimately, results matter. If consumers are not seeing a benefit for a product, they will not only discontinue use, they may also tell a friend or share their story on social media. In a world where marketers are not only concerned with what consumers buy and use today, but also what they purchase tomorrow, brand reputation is exceedingly important.
The development of retinol-containing products, which have become a staple in dermatologic practice for a variety of reasons, provides an example. In the past, products were hitting the shelves boasting the inclusion of retinol or retinoic acid, but consumers were not really getting the kinds of results promised on the packaging. As the science informing the ability for such products to penetrate the skin has unfolded, however, it has led to development of better vehicles that help the active get to where it needs to be.
“One of the issues with retinoids and why they worked okay but not great in the past is that they’re lipophilic. You have to get them through the skin. But now that they’re packaged better with better moisturizers, they’re converted and oxidized through the skin much more efficiently,” says Diane Madfes, MD, a New York City dermatologist.
The case of retinol provides but one example in the OTC skincare world where ingredient science results in products that are, truly, incomparable to what has historically been possible. Instead of OTC products serving as competition for what dermatologists do in terms of helping patients achieve healthier skin, treat conditions, and achieve a younger looking appearance, the proliferation of this category has enhanced the need for professional expertise to guide product selection.
Daily Skincare Regimens
With the multitude of products that line pharmacy and beauty store shelves promising sometimes extraordinary results for healthy and beautiful skin, patients often need help with product selection for basic skincare needs. Dr. Madfes says she listens for the patient’s chief complaint and concerns, but also notes it is important to make an overall assessment of the health of the skin. An individual expressing concern about wrinkles but who has acne, for example, will need to be directed to effective treatment options for both.
OTC skincare brands are recognizing the need for multifunctional products. Consider the evolution of the CeraVe brand, which initially launched as a ceramide-rich moisturizer to help support barrier function, especially for eczema prone skin. Today, the line inludes a moisturizing facial lotion (with SPF), Skin Renewing Day Cream with encapsulated retinol plus SPF, and a benzoyl perozide-based acne cleanser that also delivers ceramides, niacinamide, and hyaluronic acid (HA) to the inflamed skin of acne patients.
Understanding the full picture of the patient’s skin health will direct OTC recommendations. “If someone has a history of eczema,” Dr. Madfes says, “then I know that my over-the-counter products have to have a better moisturizing base—I need more Shea butters, I need more glycerines, more hyaluronic acids. So these are things that I will focus on with those patients. And if people have been taking great care of their skin for years with over-the-counter, they are going to need more prescription products or more invasive treatments and lasers or chemical peels or something else.”
Key, she says, is to keep things simple at the start, especially for the individual without a daily regimen: “Those are people whom you want to start with a retinol product that has a little mild exfoliation but that’s not going to be too drying.”
Manhattan’s Jeannette Graf, MD is also a proponent of streamlined and simplified daily care routines. She explains to patients that the skin functions differently during the day, when it is primarily a protective barrier against the environment, and at night, when skin it is renewing. A gentle cleanser is the cornerstone of both morning and evening routines. One thing she has found success with in her practice is the use of micellar cleansers. “I’ll suggest that they have it on their night table so if they realize they forgot to cleanse and they see it they can do it in bed because you have to create convenience and simplicity,” she says.
Because the skin acts as a barrier in daytime hours, daily use of sunscreen is critically important, experts continue to stress. If the skin is dry, Dr. Graf recommends a product with HA. If it is an ingredient in a brand of moisturizer the patient finds cosmetically elegant, that will eliminate the need for an additional product. Nonetheless, she says, the right moisturizer, beyond helping hydrate the skin, can support sebum and vitamin E production.
At night, skin renewal becomes the focus, which calls for a retinol product after cleansing to help that process. However, she adds a word of caution regarding the specific type of vitamin A derivative used: retinyl palmitate is not as effective as retinol; even though retinyl aldehyde is closer to the final product in the skin, it does not penetrate as effectively as retinol.
“Retinol penetrates immediately. It doesn’t matter whether you occlude it or not. Every single vitamin A, including retinyl or tretinoin, has to become all-trans-retinoic acid before it can exert any activity. Once it becomes all-trans-retinoic acid, it is recognized by over 50 DNA ligands. Because is it recognized by DNA, it is responsible for the molecular repair of skin,” says Dr. Graf.
As most dermatologists know, moisturizers come in a variety of formulations and types and are used for a wide assortment of purposes. Some lines, such as the Toleriane line, offer a variety of cleansers and leave-on formulations, such as lotions and creams, and even offer sensisitve skin cosmetics, like mascara.
In recent years, there has been some suggestion that individuals with different skin types need to use specific types of moisturizers. For instance, there is some evidence that skin of color loses moisture more quickly than lighter skin tones. While the data is conflicting, at least some studies have shown differences in the physiological properties of skin by ethnicity, including varying levels of ceramides, potential to react to exogenous insult, overall water content, and rate of transepidermal water loss. Such differences would suggest differing capacity for skin of color to react to environmental factors that might cause or exacerbate dry skin. If skin of color has different physiology compared to lighter skin, it might also have implications for the kind of moisturizer patients will gain benefit from.
There may be another context in which skin of color affects the potential to develop xerosis. There is strong evidence that in individuals with darker skin, the stratum corneum and the epidermis undergo less photoaging-related changes over time compared to lighter skin types. Because increasing age is a risk factor in developing xerosis, the suggested protective benefits of melanin against ultraviolet light might have an indirect influence on the xerotic process.
In his experience, Seemal Desai, MD, of Plano, TX, says he does not see a whole lot of evidence to support the notion that darker skin is any different in terms of moisture retention or loss, but he does point out that the protective aspects of melanin have definite implications for how harmful effects of sun damage might influence the health of the skin. In his view, it’s not necessarily the case that darker skin has any different structure or function related to moisture retention specifically; however, darker skin is less prone to be damaged by the sun, and, in turn, sun-damaged skin has greater potential to lose moisture.
OTC Pearls
Sunscreen Use in Skin of Color: Popular Myths Are Harmful
Is it true that patients with darker skin are protected against the harmful effects of sun damage and therefore don’t need to use sunscreen?
“That’s a myth,” says Seemal Desai, MD. “We need to keep educating that darker skin type patients do need UV protection because UV has been linked to basal cell and squamous cell carcinoma.”
One of the prevalent concerns from patients with skin of color is that sunscreens containing zinc or titanium, regardless of how micronized it is, tend to leave the skin looking white and pasty. In some cases, negative attitudes about the experience with those products may lead to poor compliance.
“One thing I do suggest a lot of times with darker skin type patients, and we dispense these in our office, and I encourage patients to try them, are the tinted sunscreens. A lot of times my darker skin type patients like the physical blockers with the tint because they blend into their skin tone much more evenly.”
Rethinking the Concept of Adjunctive Therapy
“Adjunctive therapy” is classically defined as an additional modality given to maximize effectiveness. In patients with acne, however, the concept may take on a different context.
“Adjunctive treatment is not going to help the efficacy; it’s going to help the tolerability. And if you increase the tolerability, you increase adherence,” says Leon Kircik, MD.
When to Say “No” to OTC
The science behind over-the-counter products has advanced tremendously, and as a result, patients can expect to see better results compared to what they would have experienced in the past. But that doesn’t mean that OTC is always the best choice. One of the important roles dermatologists can serve in educating patients about OTC products is in using their professional judgement to determine when a different approach may provide a benefit closer to their treatment goal.
“We’re lucky because as technology gets better, the over-the-counter products get better and then compliance is better for our patients at the same time,” said Diane Madfes, MD. But, she adds, “you have to be careful with patient expectations in terms of what their objectives are. Sometimes an over-the-counter is not going to be beneficial, and that’s really our judgment call. But if you don’t think it’s going to help, don’t waste the patient’s time or money on the over-the-counter.”
Sun Protection Strategies: What Else?
What are the three most important things patients can do to help keep their skin looking young and healthy? Apply sun protection in the morning, reapply sun protection a few hours later, and continue to apply sun protection throughout the day. Yet, some patients continue to resist the need to apply, reapply, and maintain a barrier. Are there other practices patients can adopt to reduce the potential for photodamage?
“A very important thing that I like to do is to tell patients, especially if they’re going away on vacation, is use SPF treated clothing,” says Jeannette Graf, MD. “They don’t have to get the bamboo organic materials, but some form of protection is a good idea, and a regular dark t-shirt, which is probably equivalent to an SPF around 9, or a white shirt that is equal to about a 3 to 5 SPF, isn’t going to be enough.”
Diet and Skin Microbiome
The skin microbiome has garnered a lot of attention recently. There is some suggestion that commensal bacteria have a pivotal role in healthy skin physiology, whereas dysbiosis of the native microbial community on the skin sets the stage for development of a variety of skin disorders. But what can patients do to restore the balance?
“Some OTC products have active cultures in them that may help to restore the microbiome, but people can also do that via taking in a healthy diet,” says Todd Schlesinger, MD.
While the role of diet in treating or preventing acne flare-ups is controversial, epidemiologic studies have consistently found that, compared to Western cultures, the prevalence of acne is far lower in non-Westernized individuals and among populations that historically subsist on hunter-gatherer diets. The microenvironment of the skin is, indeed, influenced by a number of factors beyond diet, including lifestyle, age, community, environment, and genetics. At the same time, there is also evidence that fibrous carbohydrates such as asparagus, Jerusalem artichokes, garlic, oats, and soybeans contain prebiotics that encourage microbial diversity and promote growth of healthy bacteria that contribute to the health of the skin.
OTC Helps Address Access to Care Issues
One of the more subtle aspects of the advent of OTC products in skincare is that they can help address issues related to access to care. With a number of patients either uninsured or underinsured, cost concerns have become a relevant factor in whether treatment is ever pursued. The simple fact is, if patients cannot afford safe and effective medications, they may not use them.
“One of the things that has been revolutionary for the treatment of acne is the fact that adapalene is over-the-counter,” says Susan Taylor, MD. Adapalene is one of the three retinoids FDA approved for acne. Prescription tretinoin, tazarotene, and adapalene can be expensive and not always covered by insurance. Adapalene gel 0.1% is now available OTC. Dr. Taylor thinks, “it is just revolutionary to have that active available over-the-counter.”
The Unintended Consequences of OTC
The availability of over-the-counter acne medications has inarguably improved access to safe and effective treatments, but may also have the unintended consequence of reducing interactions with professional dermatologists. That may have very real implications for the overall success of treatment.
Julie Harper, MD, says she has noticed three common mistakes patients make with their acne treatments: 1.) They use it incorrectly—usually using too much of a topical, which increases the risk for irritation, in turn prompting the individual to give up on treatment; 2.) Performing spot treatment instead of treating the whole area to try to prevent; and 3.) Quitting too soon.
“I think that’s probably a risk with the over-the-counter approaches, because if patients can easily access those, and they don’t have to come to me for a refill, they may be missing out on an opportunity for me to say, ‘Keep going, you haven’t seen all that this medication can do yet. This is not going to happen overnight,’” she says.
“You could generalize that maybe [patients with darker skin] have less wrinkles and fine lines than lighter skin type individuals,” Dr. Desai said. “We think it’s those effects of photo damage that actually help to modulate the biology of not only water in the skin but also ceramide content of the outer layer and integrity of the epidermis and stratum corneum, and also those visible photoaging changes.”
But does that mean patients with skin of color require a different approach to daily skincare ? As it turns out, the answer is nuanced. On the one hand, there may be essential building blocks for the daily regimen that are applicable to all patients: a high-quality cleanser that helps remove impurities, oils, and toxins, and balances skin pH; use of broad-spectrum sunscreen, preferably at a minimum of SPF 30; and a moisturizer. For patients concerned about signs of aging, retinol is a good addition. Where the nuance comes in, Dr. Desai says, is in choosing the right elements: sunscreens that contain zinc or titanium have a heavier texture and may not be as cosmetically elegant for skin of color patients. As well, retinol-containing products can be irritating to the skin; patients may take precautions to reduce the risk. Applying retinols at night, for example, reduces sun exposure that can exacerbate irritation. In sensitive skin, applying a moisturizer prior to the retinol is a short-term strategy to mitigate peeling and desquamation. Patients can start using a retinol every other day before transitioning to everyday use.
“If we give a retinol product that’s irritating, either prescription or cosmeceutical, we need to make sure that we counsel these patients on how to alleviate some of those cutaneous side effects, because irritation can even lead to post-inflammatory hyperpigmentation in darker skin type patients. You’re trying to treat something and make their skin better with a retinol, and you may create a different issue,” says Dr. Desai.
Anti-Aging
One popular notion around OTC anti-aging products is that they are intended to slow the appearance of aging yet are largely ineffective at treating the underlying cause. That is simply not the case, according to Dr. Graf. While cosmeceutical and physician-dispensed brands might have higher potency, and hence, are likely to be more effective and work more quickly, there are options for patients who prefer to use consumer brands. For example, she said, retinol-containing products, in addition to cell repair, help to even out photodamaged skin. A specific product she likes for sunspots is Aveeno Positively Radiant, containing an unpasteurized, non-fermented soy ingredient.
In the development of sunspots, melanin is carried by melanosomes into the keratinocyte, with the pigment ultimately yielding the hallmark darkening associated with sun-damaged skin. The soy in Positively Radiant counteracts this by fostering activity of protease inhibitors that function to prevent melanosome introduction into the keratinocyte, thereby preventing or minimizing the appearance of pigment on the skin’s outer layer. As it turns out, OTC products are designed to address the underlying biology of aging.
Dr. Madfes suggests a three-pronged approach to sun-damaged skin: reducing the effect of the color change means using products that contain vitamin C to reduce melanin in the skin and have a secondary effect of acting as tyrosinase inhibitors, thus increasing cell turnover. Ideally the product will also contain glycolic, lactic acid, or salicylic acid to further aid in exfoliation, which is the second element. And the last part is a topic that dermatologists everywhere are very familiar with: SPF. “Without good sun protection, none of the over-the-counter products are going to work long term,” she says.
When it comes to fine lines and wrinkles on the face, a different approach is needed. In this case, Dr. Madfes sees benefit in hyaluronic acid, and specifically products formulated with both high- and low-molecular weight hyaluronic acid. The higher weight component will stay on the skin’s surface to increase hydration, while lower molecular weight penetrates to stimulate endogenous production. Several lines of evidence support this kind of approach. First, the humectant properties on the surface of the skin (i.e., higher molecular weight) provide a benefit for smoother, softer, and more radiant skin. Levels of both skin hydration and HA are known to decrease with age—an apparent factor in the development of wrinkles and fine lines. Yet, while such high-molecular weight ingredients sit on the surface of the skin, there is evidence that they still stimulate production of proteins and peptides and signal enzymes within the skin that initiate and maintain collagen production. Correspondingly, HA has a functional role in supporting and organizing elastin and collagen fibers, effects that are diminished in older skin and as levels of HA decrease. Furthermore, studies support the idea that low-molecular weight- and nano-sized particles of HA affect greater anti-wrinkle efficacy relative to high-molecular weight, supporting a model in which the benefit from the topical application is proportional to molecular weight dependent percutaneous absorption.
Dr. Graf is also a fan of HA for fine lines and wrinkles. She points to Neutrogena Rapid Wrinkle Repair as an example of a product that has been carefully formulated to provide multiple benefits for this purpose. In addition to hyaluronic acid, Rapid Wrinkle Repair also contains retinol, which acts as a gentle exfoliant to remove dead skin cells and thereby facilitate penetration. As well, among its active ingredients are avobenzone and homosalate, which absorb UVA, and octisalate, which absorbs UVB, and included in the inactive ingredients are peptides that serve to send signals to stimulate neocollagenesis. The sophisticated formula science aside, it’s what the product does for her patients that most excites her. “It plumps up the skin and makes the wrinkles look less apparent,” she says.
Obviously, not all signs of aging appear on the face, and there are important differences in the skin on the body, the hands and feet, and the face. Thus, products used to address aging signs on the face may not always be effective for other body sites. However, some dermatologists are cautious about making specific recommendations for products used on non-facial sites. For one, adding an additional product adds complexity to the regimen, which might affect compliance. For another, cost may be a factor. Thus, while it is important to make body-site specific recommendations—hand lotions with high fatty acid content may penetrate better, for example—offering them as an option might be a judgement call.
OTC in Medical Dermatology
In addition to their role in good skincare practices and for addressing signs of aging, certain OTC products may also play an important role in some of the more prominent skin disorders treated in the dermatologist’s office, such as psoriasis or eczema. In both cases, treatment guidelines offered by the American Academy of Dermatology (AAD) list certain types of OTC products as treatment agents, supportive or additive to prescriptions and in-office procedures, and as agents that provide symptomatic relief.
While psoriasis and atopic dermatitis are each characterized by an inflammatory process, there are important differences in their respective inflammatory pathways, and, fundamentally, how the separate disease processes affect the skin. In psoriasis, one important treatment goal is to support the skin’s barrier function while facilitating desquamation and removal of scales. That, in turn, provides the rationale for the role of keratolytic agents like urea, mandelic acid, glycolic acid, lactic acid, and tar products. Keratolytics may also serve an adjunctive role in enhancing penetration of prescription topical applications, as well as for patients undergoing light-based therapies.
“Tar has an immunosuppressive role as well as a regulatory role for the keratinocyte, and that’s why we use it for psoriasis. It helps reduce itch and it may even be antibacterial,” says Charleston, SC dermatologist Todd E. Schlesinger, MD. “There are some topical tar treatments that can be helpful as long as that’s being done without irritation, and that’s the drawback with some of the keratolytics as well.”
Other ways OTC products come into play for psoriasis patients include use of emollient moisturizers, with ceramide- and triglyceride-based formulations being the most prevalent types. HA, another important ingredient, is used in various forms to restore and maintain skin hydration and in some cases may have anti-inflammatory and antimicrobial effects via modulation of skin innate immune functions. Emollients are an important part of promoting the skin’s protective capacity in patients with atopic dermatitis, as well. Because the innate immune system is somewhat compromised in atopic skin, other components of treatment may include topical antibacterial agents and those containing hypochlorous acid, which is known to exhibit microbicidal properties. There is at least some evidence that hypochlorous acid, especially combined with sodium hypochlorite, reduces S. aureus load on the skin of patients with eczema, thus helping to balance the microbiome. Some OTC products contain either hypochlorous acid alone or combined with sodium hypochlorite.
“The AAD produced guidelines a number of years ago for the treatment of AD which note a general lack of high-quality evidence to support use of antimicrobials and antiseptics to treat it. However, they recommend bleach baths as one of the only topical anti-bacterial options that, when combined with other measures, can improve disease severity,” Dr. Schlesinger says.
Dr. Schlesinger says he does not routinely use other bath formulations, but that the concept of bleach baths does have a rationale. Not only does an imbalance of S. aureus increase the risk of infection, but the severity of atopic response is driven, at least in part, by the inflammatory response to the bacteria. That inflammatory response has implications for filaggrin integrity. Mutations within the filaggrin gene may be present in a large number of individuals with severe forms of dry skin, including those with eczema. Thus, any further stress on these essential proteins serves to compromise their important role in skin structure (i.e., supporting barrier properties in holding keratinocytes together) and function (filaggrin has a suggested role in releasing amino acids that facilitate water retention).
The need to remove dirt and other debris from the skin is important for patients with atopic skin conditions. However, because of the compromised nature of the skin, gentle cleansers are needed, and so the active and excipient (inactive) ingredients need to be considered.
“In some patients, preservatives or propylene glycol can be irritating. So sometimes we tell patients to avoid cleansers or moisturizers that have different kinds of preservatives or things like that or fragrances that can irritate their skin,” Dr. Schlesinger says. “Our practice uses professional products like the Avene TriXera line, which is thermal spring water based and may even help improve the skin’s microbiome. What is important is to apply moisturizers frequently and in sufficient amounts to avoid dry skin.”
Acne Treatment: A Role for OTC?
FDA approval for adapalene to be sold over-the-counter in 2016 likely changed the way some dermatologists treat acne. The topical retinoid joins the class of OTC benzoyl peroxide containing products, some of which are improved from decades ago. Effaclar Duo, for example, combines micronized BPO 5.5% with exfoliating LHA in a moisturizing base. Altogether, the expanding options for OTC acne treatments expands access; however, some in the field caution that OTC will not always be suitable as a standalone option.
The pathogenesis of acne is multifactorial and thus requires a multi-pronged approach. When it comes to OTC products, they are obviously useful for good skincare practices in terms of repairing barrier function. And when it comes to treatment, products containing retinoids and benzoyl peroxide can be foundational to the overall treatment approach. Adapalene has been a mainstay of acne treatment since the mid 1990s and the move to OTC has encouraged companies to innovate new formulations—in addition to Differin, La Roche-Posay also offers 0.1% adapalene products (Effaclar). Likewise, there are a number of benzoyl peroxide products that exhibit efficacy in acne.
“I have a tendency to lean toward PanOxyl, because it’s a line I’ve used for a long time; they have a 4% creamy wash and a 10% foaming cleanser. Depending on where I’m using those on the body, I find either of those works just fine,” says Julie Harper, MD, a dermatologist in Birmingham, AL.
The biggest issue, she says, is the potential for skin irritation, which is why these kinds of products may not be best used as “leave on” products. Incorporating these actives into cleansers and washes provides an added boost to whatever else is being done with a prescription.
Sunscreen Selection Tips
Sunscreen. Such a seemingly simple product and concept, yet it seems to continually engender confusion and consternation.
Ask most dermatologists and they will say that patients need to use sunscreen on a daily basis, reapplying throughout the day to provide protection against sun damage. But ask most patients, and they will say there is massive confusion about what products to use, which are most effective, and what to look for on the label and packaging.
In one survey, 79 percent of consumers said they use sunscreen, but only 19 percent used it on a daily basis. A third of respondents said they didn’t know if they were using mineral or chemical sunscreens. But the particular ingredients may not ultimately matter: more than 60 percent of sunscreen purchases are based on the level of SPF in the product. In the end, what may be most problematic for consumers is the amount of information proliferating through the marketplace. About two-thirds of respondents to one survey said they found the topic confusing, and almost three quarters said that varying information on safety and effectiveness only stifles the ability to choose the right products.
And yet, there is urgent need for better sources of information. Each year, roughly 3.5 million individuals are diagnosed with skin cancer, and cases of melanoma and deaths from melanoma continue to increase year over year. Moreover, there is growing evidence that the level of UV radiation to which Americans are exposed to on a daily basis is increasingly rapidly, thereby underscoring the need for sun protective habits.
In the midst of all the confusion, including bans on sunscreens containing oxybenzone and octinoxate in some parts of the world, some dermatologists have decided to make specific recommendations for products they find safe and effective.
“One of my favorite sunscreens is not a drug store product, it’s a doctor’s product, and that’s the Elta line,” says Jeannette Graf, MD. “I like EltaMD, which is a zinc oxide, because you can put it on the skin around the eyes and it doesn’t burn.”
Other zinc oxide-based products, like Helioplex, are also a consideration, but Dr. Graf says she does not favor them as much on sensitive skin, such as skin around the eyes. Other popular options are the Anthelios products from La Roche-Posay, which boasts the inclusion of antioxidants designed to protect from the formation of free radicals.
However, the Anthelios line sold in the United States differs from those available in Europe, which is actually a common theme for brands distributed globally. While there are seven different ingredients offering protection against UVA approved for use in Europe, FDA has so far only deemed two to be safe and effective enough for sale in US markets—zinc oxide and titanium dioxide. Although there are not necessarily known safety concerns with other ingredients, there is simply more data on their sun protective properties than related to their potential toxicity and bioavailability. Consider Mexoryl, which has been regularly used in European sunscreens since the early 1990s. La Roche-Posay's Anthelios SX, SPF 15 is available in the US after being approved by the FDA under a new drug application (it cannot be altered in any fashion). Unfortunately for US consumers, additional formulations containing mexoryl are now stuck in a regulatory quagmire. FDA has asked for more information on safety before reviewing applications for use of mexoryl in other sunscreen formulations, including those with higher SPF. Those sorts of studies, though, could take years to complete—years in which Americans will continue to be exposed to low-energy UVA radiation that ages the skin, suppresses immune system responses, and contributes to melanoma.
Dr. Graf calls the FDA decision unfortunate, while also acknowledging it as a reality that must be dealt with. Without access to ingredients believed to offer superior protection, sunscreen producers are limited as to what they can offer US consumers. And so, the focus turns to finding cosmetically elegant products that will build compliance in the hopes of creating practices that provide at least a modicum of broad-spectrum protection.
One consideration in this regard is the growing array of tinted sunscreen options that blend naturally into the skin.
“The Elta line has a tint that patients love and it’s a universal tint so it tends to adjust to your pigment,” says Dr. Graf.
On the other hand, the white, pasty appearance associated with physical blockers can sometimes be an issue for patients with skin of color. The experience around the product, particularly if it is negative, factors into compliance—and sun protection is too important an issue to ignore. Tinted sunscreens with physical blockers may be a consideration, but in certain situations, like the patient with skin of color being treated for acne who is displaying post-inflammatory hyperpigmentation (PIH), the need to gain patient buy-in may supersede the desire for what may be considered optimal protection strategies.
“We tend to migrate to the chemical sunscreens because the chemical sunscreens don’t, in general, leave that white hue on the skin and tend to be less sticky, thick, whatever adjective you want to use. Those are the ones that I often will recommend for people with skin of color,” says Susan Taylor, MD.
In light of new data suggesting that visible light can prolong and worsen melasma and PIH, Dr. Taylor says that she has started to recommend sunscreens that contain iron oxide. Of course, even that is not as straightforward as it may seem: “Iron oxide confers a tint to the sunscreen, so you have to find a sunscreen that approximates the patient’s skin hue,” she says.
There are also products that patients like to use for cosmetic purposes that additionally provide some sun protective benefits. For example, a number of the beauty or blemish balms, or BB creams, and color correcting products, or CC creams, are formulated to provide broad-spectrum protection. Similarly, a number of daily-use moisturizers contain ingredients intended to block UV radiation, providing hydration to the skin and physical blockage of the sun’s rays. Use of such products, though, come with an important caveat: reapplying sun protection throughout the day is essential, and so it may not be possible to discontinue the need for two separate products entirely.
One of the biggest sources of confusion for consumers, and probably equally so for dermatologists, is the FDA’s proposed changes to sunscreen regulations, announced in 2019. In its proposed guidelines, FDA clarified its stance that two ingredients are “generally recognized as safe and effective” (GRASE)—zinc oxide and titanium dioxide—declared that two others did not meet the GRASE standard—PABA and trolamine salicylate—and appealed to industry for more information on a list of other active ingredients.
If there is good news in the FDA’s proposed changes, however, it is that the agency supported the pursuit of new delivery mechanisms and vehicles, such as sticks, sprays, oils, lotions, creams, butters, and gels. Some of these vehicles have been criticized for the ability to create incomplete coverage or a false sense of protection among users. Others, though, embrace them because of their inherent convenience.
“My recommendation is to put sunscreen on every single day, including a weekend where you’re not even planning on going out, because it creates a habit, and repetition is important. So is convenience. For the body, I tend to like sprays, and there are a number of options, such as sports sprays, which you don’t have to rub in, and wet sprays that you can put on but won’t release from the skin when you get in the pool,” says Dr. Graf.
Others say the availability of OTC acne products is compelling from the perspective of access, but they feel most simply are not effective enough to be considered a crucial part of the overall treatment approach. According to Loiusville, KY dermatologist, Leon Kircik, MD, one of the key reasons why patients show up in his clinic for treatment is because OTC approaches have largely been ineffective. But, he adds, there still may be rationale for using certain OTC products as an adjunct to prescriptions.
“The acne medicines that we use are quite irritating. Acne patients also have impaired epidermal barrier by nature, and the drugs that we give them actually impair the barrier even more. That means we are using something for treatment, but it’s actually making their condition worse,” says Dr. Kircik.
A strategy that Dr. Kircik uses with many of his acne patients is to recommend starting with a cleanser, and specifically one that maintains the skin’s acid mantle but “not a soap that suds; anything that produces suds is going to be high pH.” A moisturizer is typically added, but again, choice of product matters, as occlusive vehicles will only serve to cause more acne. However, contrary to popular thinking, the order in which patients apply their moisturizer and acne treatment may not matter.
“We always thought in the old days that you use the medicine first and then the moisturizer; we assumed if you put the moisturizer first the medicine would not go in,” says Dr. Kircik. “Now studies show that it really didn’t matter. If you actually use the moisturizer first, then you tolerate the medicine better. Not only that, there is no difference in efficacy.”
Philadelphia’s Susan Taylor, MD, says non-comedogenic moisturizers help balance the potential for skin drying with just about any acne ingredient or product. She often recommends them in her practice, particularly for patients with skin of color. “I think most acne medications, prescription and over-the-counter, have the potential to cause dryness and irritation, and, hence, post inflammatory hyperpigmentation in individuals with darker skin tones. I think that’s across the board,” she says.
A multitude of factors may contribute to irritation, including some that may not be as obvious, such as the ambient temperature. She has noticed that patients tend to present with dry, irritated skin more frequently in winter months compared to summer. Other factors are more obvious: 2% benzoyl peroxide has less potential to cause irritation than 10%, for example, even though studies indicate no difference in effectiveness. That may suggest a benefit for recommending patients start on a lower concentration and titrate if needed. Another potential point for patient education is the role of the vehicle in preventing or mitigating post-inflammatory hyperpigmentation (PIH).
Minding the Microbiome
The concept of the skin microbiome has garnered a lot of attention in recent years. But what is it? And why does it matter for skincare?
Microbiome refers to the collection of microorganisms in a particular environment. In the context of the skin, which is one example of a microenvironment, it refers to the commensal microbiota on the surface of the skin; this view, while sharing aspects of the literal definition, also speaks to the fact that microorganisms on the skin have a relationship with the host organism—deriving nutrition from that source without hurting or helping. In an expanded view, the microbiome also considers the genetic material of the microorganisms in a given environment.
By a strict understanding of commensal, the local flora on the skin, most often referring to the diversity of the bacterial species, does not help or hurt the host, but in the case of the skin microbiome, the constitution of local species has implications for health. That is, when certain native bacterial species proliferate, they help to maintain the health of the skin. Thus, the interaction is mutualistic (both host and microorganism benefit) rather than truly commensal, because dysbiosis of the local flora establishes conditions for compromised health of the skin.
Atopic dermatitis provides an explanatory model with respect to the impact of dysbiosis in the microbiome. Several lines of evidence show that skin of patients with atopic dermatitis is more likely to be colonized with S. aureus, at both lesional and non-lesional sites. Furthermore, the severity of the manifestation at the lesion site is directly proportional to the abundance of S. aureus, thereby implicating a loss of microbiome diversity in the pathogenesis. In turn, overabundance of S. aureus has implications for innate and adaptive immune functions, thus exacerbating inflammation and allergic reactions. S. aureus penetrance to the layer of the dermis secondary to disruptions in skin barrier function may also be consequential for triggering inflammatory pathways, whereas restoration of skin barrier function via cholesterol, ceramides, and free fatty acids improves clinical symptoms associated with atopic dermatitis. But skin of patients with atopic dermatitis is also more likely to be inhabited by other bacterial species that can serve as nutritional sources for the diverse array of fungal species that have been implicated in causing and exacerbating infections. On the other hand, colonization of beneficial bacteria on the skin, such as S. epidermidis, can have positive effects for the health of the skin. Beyond the ability to out-compete harmful species for nutritional sources in a Darwinian survival model, S. epidermidis exhibits anti-inflammatory properties, enhances production of antimicrobial peptides against pathogenic species, and is functional in amplifying immune responses in tissue and wound repair.
All of the above, however, is a vastly simplified overview of the evolving scientific understanding of how the microbiome functions in maintaining skin health. Equally complex models have been constructed to explain the role of the skin’s microbiome in other skin conditions such as psoriasis and acne. There is also promising research unlocking the implications for dysbiosis of the skin flora for exhibiting signs of aging.
With this evolving science as a precursor, attention has turned to the potential to develop pre-, pro-, and postbiotic formulations that might restore the native microbiome diversity, as well as to understanding the role of diet and other factors in this process. In a similar fashion, some research has elucidated the potentially harmful unintended consequences of topical antibacterial use (i.e., in eliminating commensal bacteria) and the unexpected benefits of adjunctive treatment strategies like dilute bleach baths (i.e., in eliminating pathogenic microbiota).
In truth, the clinical applications for impacting the health of the skin via targeting of the microbiome is likely a few years off in the future. However, it is an area of research so rich in promise that it proffers truly transformative strategies for improving patient outcomes.
“The vehicle does have an impact,” Dr. Taylor says. “In general, solutions are much more drying; a liquid solution can be much more drying than a cream or a gel for example.”
As it turns out, even if patients are using OTC products, expert advice from dermatologists is needed to guide patients toward usage strategies most likely to produce the result they want while avoiding unwanted side effects—and in fact, that sort of expertise may be even more crucial when it comes to cleansers, washes, and the like that are available in the local pharmacy, beauty supply retailer, or big box store. After all is said and done, whether or not OTCs are used exclusively, adjunctively, supportively, or as part of an overall treatment approach, individualized treatment is still paramount.
That kind of personal touch may be even more enhanced in individuals with specialized skin needs, which can be understood to encompass a wide variety of issues. Dr. Desai says that a lot of his skin of color patients come to the clinic with later stage acne, but they are not always focused on clearance as the ultimate goal. “A lot of my patients aren’t even bothered by the bumps and the breakouts. They’re more worried about the color of the skin, the pigment, the scars,” he says. “I think we have to take the time to counsel our skin of color patients that we’ve got to treat the bumps and the lumps before we treat the dark spots and the scars. Otherwise you’re just going to be chasing one dark spot for another.”
Because of the overriding concern about pigmentary changes in these patients, Dr. Desai prefers to avoid use of stronger retinoids, such as tazarotene, early in the treatment process, instead opting for tretinoin or adapalene and working up to stronger agents if necessary. Azelaic acid is another option. Because it is a tyrosinase inhibitor, azelaic acid addresses pigmentation in addition to its anti-inflammatory properties.
For patients presenting with concerns about pigmentation in addition to acne, one strategy may be to combine a hydroquinone lightening product with a retinol, with the latter both amplifying the effect of the former on the pigment as well as preventing further acne. When inflammatory lesions are present, with or without signs of early PIH, oral antibiotics added to a regimen of a retinol and azelaic acid along with a cleanser and a toner to quell the inflammatory process, might be necessary.
Another way OTC products may be helpful in the context of PIH is when used in combination with office-based procedures. One strategy Dr. Desai uses is topical azelaic acid, benzoyl peroxide, and, if the patient has oily skin, a topical retinoid used for six to eight weeks prior to a series of sequential chemical peels. “A lot of times what I’m doing now is combining an alpha- and a beta-hydroxy acid together,” Dr. Desai says.
Using appropriate sun protection is an important part of the PIH treatment process—sunscreens do not function as a treatment, per se, but they protect from further discoloration. With that as a starting point, topical treatments, such as hydroquinones, can be started to reverse areas of PIH. Prescription 4% concentration hydroquinone is likely the most effective option for this indication, but OTC lighteners may be a consideration.
“They take longer, but they can indeed be helpful,” Dr. Taylor says about 2% concentration OTC products. “Then there are a whole host of other over-the-counter products like azelaic acid, kojic acid, vitamin C, glycolic acid, all of which can help a little bit to reversing the post-inflammatory hyperpigmentation.”
Notably, newer options may soon become available to help address PIH. Thiamidol (Beiersdorf), available in Europe, Latin American, and Asia, has shown promise for hyperpigmentation.
Value of Expertise
Prescription products (and even physician-dispensed brands) are available at a greater strength or potency compared to OTC products, and there are significant differences in the testing and scrutiny of consumer brands versus pharmaceutical products. But consumers are using OTC products whether their dermatologist accepts them or not. They need help and guidance regarding what products to pick, how to use them, and which ones to avoid.
“We need to always remember the value of our expertise, and we need to be sure that we can take that expertise, not just with the prescription products, but be sure that we maintain some awareness of what is available to our patients over-the-counter that can help them,” says Dr. Harper.
In fact, she says, that is a big reason why she added a Skin Bar Boutique to her practice. Although most of her practice is medical dermatology, at least 25 percent of Dr. Harper’s practice is cosmetic, and so the ability to not only tell patients what they should be using, but actually putting it in their hands during a visit, is a way to be a full-service provider for patients’ needs.
That same idea led Dr. Graf to start an OTC skincare line under her name. “What inspired me,” she says, “was the fact that there was a gap between what you could get over-the-counter and what you could get in a doctor’s office in terms of efficacy and concentration.”
Thanks in part to the intense competition in the quickly growing OTC market, and also owing to tremendous advances in ingredient and formulation science, that gap is narrowing. In medical dermatology, better delivery systems and vehicles, coupled with introduction of new actives, has helped carve out a role for OTC products as treatment modalities, as well as adjunctive and palliative measures. For providers of cosmetic services, the convenience of OTC products can have myriad benefits, from improving the health and appearance of the skin to helping maintain the results after an in-office procedure to laying the foundation for good skincare practices.
Indeed, the proliferation of OTC has been very profitable for producers and distributors of these kinds of products. But in the end, it may be the case that patients are reaping the greatest reward.
