After much anticipation, the US Food and Drug Administration (FDA) published its Final Rule for Sunscreens on June 17, 2011, ushering in new testing and labeling requirements that would take effect in time for the 2012 sun care season. With Memorial Day Weekend 2012—the official summer kick-off here in the US—just weeks away, marketers are shipping products that meet those requirements, including claims about UVA/UVB broad-spectrum protection and skin cancer prevention and new terminology for water resistance (see box below).
But even as these newly compliant products reach shelves in time for the market’s most critical selling season, other aspects of sun care formulation and marketing remain adrift, namely dosage and the proposed SPF cap. Both issues were outlined in FDA’s Proposed Rule and Advance Notice of Proposed Rulemaking (ANPR), which were also released that same day in last June.
According to Dr. Reynold Tan, a scientist in FDA’s Division of Nonprescription Regulation Development, the agency has received information from various industry sources related to raising the SPF cap beyond 50 and popular dosage forms including sprays as well as towelettes andpowders.
But as this issue went to press, Tan asserted that FDA had yet to publish any further sunscreen rulemakings and it wasn’t ready make any announcement related to the Proposed Rule related to the SPF 50 cap issue and the ANPR related to dosage forms.
Raw Elements USA’s sun care products were lauded by the Environmental Working Group.
“In the dermatologic community, we see it as positive step,” said Dr. Steven Q. Wang, director of Dermatologic Surgery and Dermatology at Memorial Sloan-Kettering Cancer Center in Basking Ridge, NJ.
Specifically, Wang pointed to the rule’s critical wavelength testing criteria and labeling issues, such as the back panel drug box, and verbiage related to skin cancer and water resistance claims, as positives.
BabyGanics is rolling out two new sun care products this season.
This year, Wang is determined to reach even more consumers via his new website, www.sunscreenguide.com, which relays information on sunscreen basics, current regulations, application and other issues.
Giving Them What They Want
As FDA continues to grapple with the Proposed Rule and ANPR, sprays and SPF levels above 50 remain on stores shelves—and on launch pads too as marketers push ahead with new rollouts even though they are “in limbo,” as one industry executive told Happi. And that’s because these products resonate with consumers, say marketers from the largest shareholders to niche players in this multi-million dollar industry.
“The number one interest for consumers is a product that protects, and is also convenient and easy to use,” said Dr. Patricia Agin, scientific affairs leader at the Coppertone Solar Research Center. “The more convenient and more aesthetic you can make the product, the more likely consumers are to use it and to reapply it.”
When it comes to convenience alone, sprays rule the roost and are big business for sun care marketers, who continue to expand their offerings. In a sure nod to the growing popularity of this delivery form, Panama Jack has swapped out its 8oz lotion for a new spray gel formulation for 2012.
Hampton Sun is rolling out a new kids product.
Driven by the need for hands-free application, sprays are especially popular delivery methods in the sport-oriented sun care sector, and formulators are going beyond the basics, adding performance and feel characteristics to lure outdoor enthusiasts.
New sprays this season include Aveeno Hydrosport SPF 30; BullFrog Mosquito Coast SPF 30, Chattem’s continuous spray product designed to protect and keep insects at bay; and Banana Boat Sport Performance CoolZone, a continuous spray sunscreen that provides active UVA and UVB protection that instantly cools skin on contact, according to the brand, which is owned by Energizer Personal Care.
Coppertone’s roster of launches for 2012 also includes continuous sprays (SPF 15, 30 and 50+) within its Sport Pro range. Coppertone Sport Pro Series with DuraFlex is billed as “high performance equipment” for active sports enthusiasts as it is said to move with your skin even during vigorous workouts.
According to Dr. Agin, DuraFlex is “a dual-polymer system, offering more strength, more flexibility and holds sunscreen on the skin as it allows the skin to breathe.”
Newpolymer technology is also driving expansion of “wet skin” application products—amust-have for parents with children who aren’t willing to sit still for thefirst dose of sunscreen, much less towel off for reapplication.
You’re All Wet
Coppertone Wet ‘n Clear kids is a broad spectrum SPF 45+ product that can be applied to wet skin.
Tackling that issue head-on is Coppertone with its Wet ‘n Clear Kids SPF 45+. This continuous spray sunscreen visibly cuts through water and sprays on clear without towel drying, offering broad-spectrum UVA/UVB protection that is water resistant for 80 minutes. It has a new polymer system that addresses certain skin issues such as feelings of dryness or tightness, concerns consumers had about some continuous spray formulations, noted Dr. Agin.
No-Ad Products has added No-Ad Splash Broad Spectrum SPF30 Sunscreen with WetSkin Tech, which is water resistant for up to 80 minutes. The formulation features a “super water-repellent polymer originally developed for surgical use in the medical field,” according to the Cocoa, FL-based brand.
At Johnson & Johnson there are new lotion and stick formulations within its Neutrogena Wet Skin line. Encompassing a unique blend of water-repelling emollients and polymers, the formulation allows UV filters to set up quickly to provide the same waterproof protection as when applied on dry skin, according to the brand.
Ingredients Out, Ingredients In
Even as science delivers performance and aesthetics consumers want, groups such as Environmental Working Group (EWG) are taking issue with modern sunscreen formulations. For better or worse, EWG’s scrutiny of sun care ingredients—including those with long histories of use in the marketplace—has prompted firms to reformulate existing products.
Ocean Potion, for example, has this year eliminated oxybenzone from its products with SPF 50 or lower, balancing out the formulation with other filters including octocrylene.
According to Sam DeAngelo, senior VP at Ocean Potion, “while oxybenzone is FDA–approved, and has been available for 20 years, the Environmental Working Group continues to make assertions regarding the safety of the sunscreen claiming it possibly prompts the production of harmful free radicals. While we feel the compound is safe and it is still recommended by the Skin Cancer Foundation, we have chosen to offer the consumer an alternative to the usual sunscreen.”
As consumers take greater interest in what’s inside their sprays and lotions, big brands are touting their use of mineral-based materials. Banana Boat, for example, is rolling out new Natural Reflect sunscreen lotion, which features zinc oxide and titanium dioxide (TiO2).
Nowhere is the call for mineral-based ingredients like zinc oxide and TiO2 louder than in the juvenile sun care market, a category fueled by parents’ desires to use more “natural” products.
Hicksville, NY-based BabyGanics is delivering two new SKUs this season that connect with modern parents’ sun care needs. BabyGanics Cover Up Face & Body Sunscreen Spray SPF 50+—which is free of PABA, parabens, sulfates, phthalates, nanoparticles and retinyl palmitate—contains octinoxate, octisalate and 11.2% zinc oxide for broad spectrum UVA/UVB coverage. Also new from the firm is BabyGanics Smooth Moves Moisturizing Lotion with SPF 15, a fragrance-free product that incorporates octinoxate 1.15% and zinc oxide.
Neutrogena’s new Pure and Free Baby Faces Sunscreen SPF 50 follows the trend too as it is a formulated blend of titanium dioxide and zinc oxide in a proprietary tear-free formula.
Sharks and Minnows
Ingredients aside, for many parents, sun care is a numbers game—and they tend to gravitate to higher SPFs.
“Parents are looking for a high SPF—with parent-friendly details like a formula that can be applied to wet skin or a travel twist cap,” said Salvatore Piazzolla, owner and president of S&G Hampton Sun LLC, which is adding a new Kids SPF 70 product to its collection this season, despite the uncertainties surrounding FDA’s SPF cap.
Overall, Piazzolla sees the Final Rule as a plus for his growing firm, which saw sales double between 2010 and 2011 and is now expanding internationally.
DuraFlex technology is new at Coppertone.
Another company looking to grow its sun care business is Raw Elements USA. After a pilot launch last year in New England and south Florida, this start-up is going national this year, according to president/founder Brian A. Guadagno.
Guadagno’s road to Raw Elements is a common tale among new firms in personal care; the brand was born from his own experience with the sun care products he used as a lifeguard.
“At the end of the day after applying commercial brands with high SPF numbers five or six times, I was still disappointed with how I looked when I got home. As a career lifeguard, I felt a bit foolish. I never took the time to look into what I was using, how it worked and what I put onto my body,” he said.
Dissatisfaction turned to “obsession,” as Guadagno began a quest to develop products that would meet his own demands. Now after a year in the marketplace, he’s well aware of the challenges Raw Elements faces as a minnow among the market’s sharks.
“Our arsenal is small, but social media is a tool to attempt to help level the playing field,” he told Happi.
What may also help is the brand’s rating from EWG. Last summer, EWG’s Sunscreen Guide gave Raw Elements Eco Formula 30+ and Eco Stick 30+, No. 1 ratings, which should help drum up business.
“It’s an honor to have a No. 1 rating for safety and efficacy,” Guadagno said. “The work EWG does is really fantastic and is a great foundation for awareness, especially in the sunscreen category.”
Industry executives insist it is important for people to find a product they connect with, be it a big brand or niche offering like those from Raw Elements.
“Sunscreen isn’t one size fits all,” Guadagno explained. “Consumers have different needs, different skin types. It is important for them to find a product that they identify with and works for them.”
Hilary Daly, senior brand manager, Banana Boat, echoed that sentiment. “No two consumers are exactly alike, so choice is probably the biggest key attribute…we feel like it’s important to offer a full spectrum of products, and hopefully help the consumer make an educated decision.”
And that’s a rising tide that can lift all boats. Choice can help increase sun protection compliance (good news for the medical community and consumers’ health)—and drive sales at retail as well.
FDA's Final Rule
• Here is a look at the main points of the new Final Rule, as outlined by the US Food and Drug Administration.
The new final rule includes the following requirements:
• Broad Spectrum designation. Sunscreens that pass FDA’s broad-spectrum test procedure, which measures a product’s ultraviolet A (UVA) protection relative to its ultraviolet B (UVB) protection, may be labeled as “Broad Spectrum SPF [value]” on the front label. For Broad Spectrum sunscreens, SPF values also indicate the amount or magnitude of overall protection. Broad Spectrum SPF products with SPF values higher than 15 provide greater protection and may claim additional uses, as described in the next bullet.
• Use claims. Only Broad Spectrum sunscreens with an SPF value of 15 or higher can claim to reduce the risk of skin cancer and early skin aging if used as directed with other sun protection measures. Non-Broad Spectrum sunscreens and Broad Spectrum sunscreens with an SPF value between 2 and 14 can only claim to help prevent sunburn.
• “Waterproof,” “sweatproof” or “sunblock” claims. Manufacturers cannot label sunscreens as “waterproof” or “sweatproof,” or identify their products as “sunblocks,” because these claims overstate their effectiveness. Sunscreens also cannot claim to provide sun protection for more than two hours without reapplication or to provide protection immediately after application (for example “instant protection”) without submitting data to support these claims and obtaining FDA approval.
• Water resistance claims. Water resistance claims on the front label must indicate whether the sunscreen remains effective for 40 minutes or 80 minutes while swimming or sweating, based on standard testing.
Sunscreens that are not water resistant must include a direction instructing consumers to use a water resistant sunscreen if swimming or sweating.
• Drug Facts. All sunscreens must include standard “Drug Facts” information on the back and/or side of the container.
• Here’s a look at some new launches that blur the line between skin care and sun care.
For acne-prone consumers, Neutrogena Clear Face Liquid Sunscreen Lotion contains a blend of natural ingredients consisting of three plant extracts proven to cleanse excess oil, reduce inflammation and sooth irritated skin.It was clinically tested on acne-prone skin to provide superior broad-spectrum UVA/UVB protection while helping keep skin clear of sunscreen breakouts.
At Ocean Potion, it’s all about olives. The brand has introduced Anti Skin Aging Face Potion Broad Spectrum SPF45 Daily Lotion with Olive Extract, which features maslinic acid (pentacyclic triterpene), a new molecule extracted from olives to protect and regenerate cells, and Olive Squalene for maximum hydration. The formulation also contains vitamin K to reduce the appearance of dark under-eye circles, vitamins A and E to neutralize free radicals and repair cell membranes, and 200 IU of vitamin D3 to help promote good health, according to the company.
Jurlique is also going for sun protection and anti-aging repair. Purely Sun-Defying Moisturizer with SPF 15 Sunscreen features a non-whitening formula that contains ingredients like buriti oil to improve skin elasticity and regenerate the hydrolipid barrier and natural red sea algae to help protect against UVA-induced stress and photoaging in addition to zinc oxide and TiO2.
HydroPeptide’s SPF 30 Anti-Wrinkle Skin Enhancing UV Protection is an SPF 30 day cream with skin-matching technology that the firm says provides “a touch of warmth that is flattering to all skin tones with adequate SPF coverage.” The formula contains self-adjusting color-changing spheres as well as niacin, aloe, green tea and acne-fighting galanga root.
And while many of these products are designed for the face, there’s another area that warrants daily sun protection: the scalp. The Hair Loss Control Clinic is touting a new broad spectrum SPF 46 sunscreen developed just for this delicate, but often overlooked region. The formulation, which is sprayed directly onto the scalp or hair part, goes on white to ensure complete coverage before it dries clear. It contains transparent micro zinc oxide and octinoxate in a non-comedogenic formula free of fragrance, parabens, colorants and sulfates.
More States Aim to Keep Teens Away From Indoor Tanning
• Prom season is just around the corner, which has thousands of teenage girls swarming department stores shopping for cocktail dresses and shoes, figuring out which couples to share a limo or party bus with, and looking to liven up their pale winter complexions. Unfortunately, to take care of the latter, many will look to indoor tanning salons to “get some color” for the big event.
Nearly 30 million people in the US, including 2.3 million teens, use tanning booths annually despite warnings from public health agencies about their potential to cause skin cancer, according to healthcare advocates. Studies show that exposure to UV radiation from artificial tanning devices is associated with a 75% increased risk of melanoma, the deadliest form of skin cancer, and non-melanoma skin cancer, such as squamous cell carcinoma and basal cell carcinoma.
According to the Skin Cancer Foundation, new research has shown that those who make just four visits to a tanning booth per year can increase their risk for melanoma by 11%, and their risk for the two most common forms of skin cancer, basal cell carcinoma and squamous cell carcinoma, by 15%.
California currently is the only state in the US to have legislation that bans teens from indoor tanning. In October 2011, Gov. Jerry Brown signed Senate Bill 746, which prohibits minors (under the age of 18) from using tanning beds.
Now, more state governments hope to follow in the footsteps of California, with the most recent additions being Idaho and Maryland, both of which introduced similar legislation last month.
Maryland State Senator Jamie Raskin, Delegate Kirill Reznik and Delegate Mary Ann Love joined 11 additional legislators in the Maryland State Senate and House of Delegates in co-sponsoring Senate Bill 213 and House Bill 207 to prohibit use of tanning devices by minors under the age of 18.
Under current Maryland law enacted in 2008, minors are permitted to use a tanning device at a tanning facility if a minor’s parent or legal guardian signs a consent form. (Interestingly, Howard County in Maryland joins California as the only jurisdictions in the nation to currently prohibit access to tanning facilities by minors under 18.)
A few weeks after Maryland, House Bill 486 came in the Idaho legislature, which would ban the use of indoor tanning devices by minors under 18.
The bill, which is chiefly supported by Rep. John Rusche, MD, (D-Lewiston), the House Minority Leader and Ranking Minority Member on the Committee, is currently being considered by the House Health & Welfare Committee.
Advocates say a ban for minors is essential because parental consent laws are not working.
According to Dr. Lindsay D. Sewell, president of the Idaho Dermatology Society, “we do not allow children to smoke tobacco if they have parental consent. We should protect our children from other cancer-causing agents, such as UV radiation from indoor tanning devices.”
In addition to Idaho and Maryland, Arizona, Connecticut, Florida, Iowa, Illinois, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Washington, Vermont and West Virginia are considering a similar proposal.
In February, a report released by leaders of the House Committee on Energy and Commerce stated that tanning salons are routinely not providing accurate information about skin cancer and other risks to teens seeking their services. The report found that the vast majority of tanning salons contacted by committee investigators provided false information about the serious risks of indoor tanning and made erroneous claims about the health benefits that indoor tanning provides.
Committee investigators representing themselves as fair-skinned teenage girls contacted 300 tanning salons nationwide.The investigators asked each salon a series of questions about its policies and the risks and benefits of tanning.Committee investigators also reviewed the print and online advertising of tanning salons.
When asked whether tanning posed any health risks for fair-skinned teenage girls, 90% of the salons stated that indoor tanning did not pose a health risk.When asked about the specific risk of skin cancer, 51% of the salons denied that indoor tanning would increase a fair-skinned teenager’s risk of developing skin cancer.Salons described the suggestion of a link between indoor tanning and skin cancer as “a big myth,” “rumor,” and “hype.” Four out of five (78%) of the tanning salons claimed that indoor tanning would be beneficial to the health of a fair-skinned teenage girl, according to the report.
All Kidding Aside
• Around the kiddie pools of America, parents are religious about slathering sunscreen on their babies, toddlers and grade-schoolers. But as kids age and wearing sun protection becomes more of their own business, they may slack off or worse yet, look to intentionally get tan—and that has dermatologists concerned.
A study published online by Pediatrics, the official journal of the American Academy of Pediatrics, shows that many pre-adolescents aren’t using sunscreen on a regular basis.
Data were analyzed from 360 participants in a study conducted among fifth grade children in 2004 and again in 2007. In 2004, 53% of the students reported having at least one sunburn during the previous summer, and this proportion did not significantly change by 2007, whereas liking a tan and spending time outside to get a tan significantly increased.
In 2004, 50% of students reported “often or always” use of sunscreen when outside for at least six hours in the summer; this proportion dropped to 25% at the follow-up evaluation, according to the study.
“This is an alarming trend,” said Steven Q. Wang, director of Dermatologic Surgery and Dermatology at Memorial Sloan-Kettering Cancer Center in Basking Ridge, NJ.
With at least 50% of children experiencing sunburn before age 11 and again 3 years later, targeting children in pediatric offices and community settings regarding unprotected UV exposure may be a practical approach, according to the authors. Because periadolescence is a time of volatility with regard to sun behaviors, learning more about children who receive sunburns versus those who avoid them is a critical research task.