05/01/2010 05:12 am ET | Updated Nov 17, 2011

Let The Sun Shine: Cosmeceutical Science Part 2

Vitamin D3 is not only great for your bones, but it helps prevent illnesses such as heart disease, high blood pressure, cancer, Type 1 diabetes, rheumatoid arthritis, multiple sclerosis and other conditions often caused by a poor immune system. In spite of this, many adults have low blood levels of vitamin D3. As we drink less and less fortified milk and get less sun exposure, we tend to be more dependent on vitamin supplements for vitamin D3. Unfortunately, multivitamins do not contain the form of vitamin D3 the body produces and necessarily needs.

Here in the US, there are an estimated 10 million Americans over the age of 50 who are diagnosed with osteoporosis because of vitamin D3 deficiency. Vitamin D3 is needed to absorb calcium from the diet. Without such adequate calcium, osteoporosis will result. Low levels of vitamin D3 have also been reported in people who live in areas with heavy cloud cover or high air pollution, both of which can screen out the sun's ultraviolet (UV) rays.

Many people living in the Southern United States can get enough vitamin D by getting about 10-15 minutes of sun exposure on their arms and/or legs a few times a week -- as long as they don't use sunscreen, which blocks some of the UV rays necessary to make the vitamin. Along with geography, factors such as age and skin pigmentation are important in determining vitamin D needs. Dark pigment in the skin reduces the skin's ability to synthesize vitamin D3 from sunlight by up to 95 percent. You may ask, what about the dangers of sun exposure that dermatologists often warn us about? Moderate sun exposure to arms and legs for short periods of time does not increase the risk of serious skin cancer. If one chooses the oral route, 200 IUs (international units) is currently the recommended dose for those up to age 50. However, these doses must increase with age because older skin produces less vitamin D3.

Unfortunately, this daily dosage recommendation was developed in the late 90's and currently the US Institute of Medicine Dietary Reference Intakes states that the safe upper limit for vitamin D3 ingestion is 2,000 IUs for children, adults, and pregnant and lactating women. Some experts have suggested increasing this recommended upper limit to more than 2,000 IUs daily but large doses can be potentially harmful. Putting the upper limit aside, the current recommendations for infants and adults are to take a daily vitamin D3 supplement of 1,000 IUs or to get safe sun exposure to maintain proper blood levels of vitamin D3 and reduce the risk of common cancers, type-1 diabetes, multiple sclerosis, rheumatoid arthritis, and inflammation associated with cardiovascular diseases.

Sunlight will only produce as much vitamin D3 as you need, so there is no fear of overdosing from the sun. Indeed, sunshine and supplements -- not food -- are the best sources of vitamin D (providing of course that you choose a supplement with D3.) Sunlight is the easiest -- it's free, and your body is very efficient at making vitamin D3 from the sun. Good dietary sources are fortified foods such as milk, yogurt, margarines, etc; but diet alone won't work unless you're an Eskimo who loves fish and milk. So get limited exposure to sunlight and take a vitamin supplement.

Now, before you run around the beach without sunscreen on or throw your baby out into the midday sun, all the above is saying is that some degree of sun is beneficial and one need not be covered from head to toe with sunscreen and live in a cave 24 hours a day. Remember, the availability of good sunscreens is critical for the public's health. This is necessary to protect the skin from cancer, melanomas, and other forms of skin cancer, and photo-aging. Recently, the journal "Nature" released elegant genetic data that supports the contribution of the sun to the formation of melanoma.

The question at the center of dermatology today is when will the FDA issue guidelines for sunscreen use? After a 32-year delay, the FDA will hopefully release labeling soon to finally give consumers a better idea of the sun protection they're getting when they buy a sunscreen. For the first time, sunscreen manufacturers will be required to provide information on the amount of ultraviolet A protection their sunscreen provides. Ultraviolet light is composed of the shorter, sun burning rays also known as UVB and the longer rays that penetrate more deeply into the skin and can possibly do more damage to the body as a whole are called UVA.

To prevent a "numbers game", sun protection factors (SPF) of more than 50 will be eliminated. These rules were supposed to have been finalized before the end of 2009. Once these rules are implemented, the sunscreen manufacturers will have a year to 18 months to make the label changes or provide scientific evidence justifying a higher SPF rating. No longer will words like "sunblock", "waterproof", "sweat-proof", "all-day protection" or "will prevent pregnancy" be allowed on sunscreen labels. Furthermore, labels will more than likely have to advise consumers to limit their time in the sun, wear protective clothing and reapply sunscreen at a minimum of every two hours, especially after swimming or perspiring.


(According to the Environmental Working Group)

As more Americans than ever are aware of the danger to their skin from UV radiation, they are using sunscreen to protect themselves from sunburn and guard against skin cancer. It stands to reason that the top choices include products with high SPF ratings and that are waterproof or that advertise "broad spectrum" protection. We unwittingly trust that the claims on the package will ensure that these products truly protect our skin and our health. Sadly, that is for the most part a lie. How long has the FDA been working on mandatory sunscreen safety standards? Only for the past 30 years!!! Furthermore the FDA expects manufacturers to follow safety standards voluntarily. I for one know manufacturers do nothing voluntarily. The FDA issued its latest draft in August 2007, which included a proposal for first-time ever UVA standards, but still has failed to finalize the standards to make them mandatory. Instead of enforceable standards, each sunscreen manufacturer is free to decide on test methods, advertising claims, and the level of protection they are supposedly providing consumers. While health authorities recommend sunscreen, we are left wondering which of the hundreds of sunscreens will really protect us.

The FDA is violating a Congressional mandate that required the agency to finalize sunscreen safety standards by May 2006. How is it possible that the FDA ignores Congress and consumers? Why has the FDA procrastinated so long in setting standard?

One wonders if Big Pharma is not thee reason behind this. Why are private organizations such as "The Skin Cancer Foundation" allowed to endorse sunscreens and the FDA does not? Individuals who run the Skin Cancer Foundation" are known to receive large grants and sponsorship from Big Pharma. Doesn't that bring into question their recommendations?

With no guidelines or mandatory sunscreen standards, companies are free to use marketing terms that the FDA has said are unacceptable, misleading or confusing. They are free to sell products that would be considered misbranded if the Agency finalized its guidelines. These terms include "chemical-free," "non-chemical," "help prevent skin damage," "all day protection," "mild as water," and "blocks all harmful rays" as well as terms like "sunblock," "reflects," "shields," "protects," "filters," "screens sun's rays," "sun's harmful rays," and all SPF designations greater than 50. Questionable product claims are widespread. Until the FDA sets an effective date for these standards to be a reality, industry is free to use hyped claims. Without labeling restrictions, consumers are buying products that don't deliver what they promise.

The FDA faces pressure from states and Congress to set UVA standards and approve new UVA sunscreens to protect the public. A number of legal actions have resulted from this delay and from companies' decisions to inflate claims, including 9 class-action false-advertising lawsuits, a State Attorneys General petition in 2006 requesting the Agency to set standards and the Congressional mandate for the FDA to finalize the sunscreen standards. At least two subsequent written requests from seven Senators urging the Agency to finalize the monograph have gone unheeded. Furthermore, the number of sunscreens has increased at an alarming rate, with over 3000 products available at present.

Most sunscreens protect from UVB, or sunburn radiation. Far fewer brands contain ingredients that block UVA radiation, even though a growing number of studies show it is even more harmful than UVB radiation. UVA radiation hastens the progression of skin cancer, suppresses the immune system, and causes photoaging of the skin over time. Despite the fact that 74 % of sunscreens now contain UVA filters, 1 in 10 products confers dangerously low levels of UVA protection.

No single strategy -- except of course, permanently staying inside away from windows -- accomplishes perfect sun protection. Nonetheless, sunscreen has improved substantially over time. Decades ago, it protected only against UVB, the sun's short-wave radiation ranging from 290 to 320 nanometers (nm). Research had clearly linked UVB to sunburn and skin cancer. However, exposure to UVA, long-wave radiation between 320 and 400 nm, was considered of little consequence.

Then UVA was shown to be the primary cause of premature skin aging (photoaging) and to exacerbate UVB's carcinogenic effects. UVB was considered the primary offender in sun damage and skin cancer until studies were published showing that UVA and UVB combined were more damaging than UVB alone. Due to such findings, broad-spectrum UV protection was born as manufacturers added chemicals broadening sunscreen coverage into the UVA range. Unfortunately, no standard exists in the U.S. to measure UVA protection. It does in Europe but the FDA has never approved one. The standard we have, SPF (sun protection factor), is a holdover from when sunscreens shielded against UVB alone; it only measures UVB protection.
People buy high-SPF sunscreens assuming they've purchased products that maximize sun protection. High SPF products do protect you from sunburn but they don't necessarily block UVA rays. These rays are the more deeply penetrating radiation linked to skin aging and wrinkling, immune system suppression and possibly skin cancer.

In an analysis of 1,740 name-brand sunscreens on the market as of summer of 2009, the Environmental Working Group (EWG) found that 60% of sunscreen products offer inadequate protection from the sun, or contain ingredients with significant safety concerns. Leading brands were the worst offenders.

This is skin insanity in that Americans are using sunscreen to protect themselves from sunburn and to guard against skin cancer. To use products that are ineffective is like applying the emperor's new cream. Only 7% of 1,740 products tested blocked both UVA and UVB radiation, remained stable in sunlight, and contained few, or no, ingredients with significant known or suspected health hazards. This is a reflection of the rampant problems in the pharmaceutical/cosmetic industry. The fact that the FDA does not require that sunscreens guard against UVA radiation is a significant problem. These deficiencies in sunscreens persist because of the FDA's delay in finalizing the standards contained in the monograph.

An ideal sunscreen would be stable in the sun. Some active ingredients are more stable than others, but nearly all ingredients break down to some extent in the sun. Many sunscreen ingredients break down in the sun in a matter of minutes or hours, and then let UV radiation through to the skin. Forty percent of products on the market contain ingredients that may be unstable alone or in combination. The FDA has not proposed requirements for sunscreen stability.

Most sunscreen chemicals are far from innocuous. Many of the sunscreen products on the market present obvious safety and effectiveness concerns to the public. In sunlight, some release free radicals that can damage DNA and cells, promote skin aging and possibly raise risks for skin cancer. Some act like estrogen and may disrupt normal hormone signaling in the body. Others may build up in the body and the environment. Some sunscreen ingredients absorb into the blood, and some are linked to toxic effects. The FDA has not established rigorous safety standards for sunscreen ingredients nor fully examined these effects.

Additionally, some sunscreens contain nano-scale ingredients that raise potential concerns. Micronized and nano-scale zinc oxide and titanium dioxide are present in many of the available "chemical free" sunscreens. While skin absorption of these products has not been a problem, studies of other nano-scale materials have raised concerns about the toxic effects of these agents on the lungs from powder and spray sunscreens. What's more, the FDA has failed to approve many effective UVA filters available in Europe that, if approved here, could replace these nano-scale ingredients.

Now with the approval of Mexoryl and Mexoryl SX, we have effective UVA blockers with photostability. These specific UVA blockers had to undergo an approval process at the FDA unlike one that had never been seen before in the cosmetic world. One wonders if Big Pharma was the reason behind this?

What seems quite ridiculous is that the FDA has approved just 17 sunscreen chemicals for use in the U.S., while 29 are approved in the E.U. Furthermore, the FDA has approved only 5 chemicals effective in the UVA range for use in the U.S., and has failed to approve new, more effective UVA filters available in the E.U. and Asia (except for the recent approval of Mexoryl /ecamsule.) Effective sunscreens not approved in this country are in widespread use elsewhere in the world. The FDA sorely needs to improve its sunscreen review process to give consumers access to the best products possible.

Sunscreens with SPF 50 - 100+ might tempt you to stay out longer in the sun, but they block just 1-2% more of the sun's rays than an SPF 30 sunscreen and aren't required to block UVA. Hundreds of all-day moisturizers advertise SPF, but 1 in 5 offers little protection from harmful UVA rays. Some break down well before the day's end. A new government report attributes an increasing incidence of malignant melanoma among people who work indoors to UVA rays shining through windows onto unprotected skin. Lip cancer is most common on the bottom lip where sun exposure is most direct. Two of 5 lip balms with advertised SPF offer poor UVA protection.

Oxybenzone is a hormone disruptor used in some sunscreens. Nine per cent of oxybenzone applied to the skin absorbs into living tissues and blood vessels below the surface. In EWG's database of 2,073 sunscreen brands, at least 25% fewer products contained oxybenzone in 2009 compared to 2008. EWG recommends that consumers avoid sunscreens with oxybenzone.

In summer 2008, less than one third of sunscreens on the market contained any of the 4 strong UVA filters that the FDA has approved for use in sunscreens (avobenzone, Mexoryl, titanium dioxide, and zinc oxide).

By summer 2009, this number had risen to over two thirds. Many manufacturers reformulated their products to include UVA filters, and others introduced new UVA-blocking products to the market. Unfortunately, avobenzone (parasol1789) unless stabilized quickly breaks down on exposure to the sun and nano-sized titanium and zinc dioxide are potentially problematic if breathed into the lungs. Are there products I recommend?

Yes there are ... I look for products with a stabilized parasol 1789 or Mexoryl (ecamsule.) Are there sunscreens that have these? Yes there are and in 2010 we need more than 2 families of good products in the USA! The FDA must wake-up!

Remember that no matter how good a sunscreen is, some UV reaches the skin. Sunscreen is only one vital part of a comprehensive sun protection program that includes UV-blocking sunglasses, a wide-brimmed hat, and other sun-protective clothing, as well as shade, especially between 10 a.m. and 4 p.m. But please don't just read this but write, call, scream Just do something that will awaken the FDA to this critical issue. Remember an ounce of good sunscreen is worth its weight in gold.