Manufacturing Sunscreen Products



Days are getting longer, the sun is shining, temperatures are rising and it’s days like these that get people in the mood for a little sun worship. But, did you know that skin cancer is the most common form of cancer in the United States? More than 3.5 million skin cancers in over two million people are diagnosed annually[1]. Facts like these compel the common consumer to run for the sunscreen. This causes a chain reaction because skincare companies want a piece of the action, but they also know that consumers want a sunscreen product that is “natural” and doesn’t contain chemicals of concern.

It is certainly compelling for small skincare manufacturers who want to gain market share by offering “natural” sunscreen. However, use of the term "sunscreen" or similar sun protection terminology in a product's labeling generally causes the product to be subject to Food & Drug Administration (FDA) regulation as a drug. Some ingredients approved as "sunscreens" may have alternate purposes in a product, such as titanium dioxide to make the product white. To avoid consumer misunderstanding, if a cosmetic product contains a sunscreen ingredient and uses the term "sunscreen" or similar sun protection terminology anywhere in its labeling, the term must be qualified, in accordance with 21 CFR 700.35(b), by describing the benefit to the cosmetic product provided by the sunscreen ingredient (for example, "Contains a sunscreen to protect product color."). Otherwise, the product may be subject to regulation as a drug (21 CFR 700.35)[2].

There are two basic types of sunscreen products on the market: products that penetrate the outermost layer of skin to absorb ultraviolet rays, and products which coat the surface of the skin to act as physical barriers to ultraviolet rays. Both of these types are rated with a sun protection factor (SPF), which lets the consumer know how much protection against UVB rays the product provides. Any product that declares a SPF on the label, qualifies as a sunscreen and is beholden to FDA requirements for Over The Counter (OTC) drug products. OTC monographs define the safety, effectiveness, and labeling of OTC active ingredients. If a drug is in the OTC final monograph, companies can manufacture and market that OTC product without FDA pre-approval[3].

Regulatory hurdles pose the greatest barrier to entry into the Sunscreen Manufacturing industry[4]. In order to sell a sunscreen product, your company must follow one of two avenues:

To manufacture and sell your own sunscreen, you must follow the Food & Drug Administration guidelines for OTC drug products:

  • FDA Registration: Sunscreen manufacturers must register with the FDA, work under GMP guidelines, and update their list of drug products twice annually.
  • Labeling rules: All sunscreen ingredients must be listed separately in the ingredient list under "active ingredients" together with the concentration used in the product.
  • Validation of claims: Claims made on the label suggesting that the product offers sun protection (UVA and/or UVB) must be substantiated with clinical and/or in-vitro testing.   

Alternately, there are numerous private label manufacturers who can manufacture sunscreen products according to FDA guidelines and package those products under your company name. This process ensures the following:

  • FDA Registration: Sunscreen “distributors” are not required to register with the FDA. This is the responsibility of the sunscreen manufacturer. As long as you are distributing a sunscreen manufactured by a qualified contract manufacturer, it is that manufacturers responsibility to register the manufacturing facility and the formula. They must work under GMP guidelines and update their list of drug products twice annually.[5]
  • Labeling rules: All sunscreen ingredients must be listed separately in the ingredient list under "active ingredients" together with the concentration used in the product. Your contract manufacturer should provide you with labels that follow FDA labeling guidelines for OTC drugs.
  • Validation of claims: It is the responsibility of the contract manufacturer to ensure that the claims made on the label suggesting that the product offers sun protection (UVA and/or UVB) are substantiated with clinical and/or in-vitro testing. Your contract manufacturer should be able to provide you with documentation corroborating any product claims.

Offering sunscreen products is not an unattainable goal, but it is imperative that your small business be aware of the requirements prior to marketing this class of products. Failure to comply with FDA guidelines may result in regulatory action including (but not limited to) your product being classified as misbranded, mandatory product recalls and fines.[6]

References:


Allison B. Kontur is an inventive scientist and educator specializing in natural cosmetic formulation and short-run, private label skincare. Since 2005, she has worked as chief cosmetic formulator, business consultant and CEO of various skin care companies. Allison is the co-founder of AliMar Labs, LLC, (www.alimarlabs.com) a private label manufacturer specializing in ultra-low minimums, as well as co-founder of the Vegan skincare line, Sydni Monique (www.sydnimonique.com).

Clever Ways To Connect to Your Customers Through Email


Email marketing can be one of the most cost-effective means of reaching your customers, but given that New York Times estimates that corporate workers get at 105 emails each day, an effective strategy starts with getting your email noticed among the sea of electronic communications. Here are four clever ways to connect with your customers through email.
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  1. Tease with a provocative headline.  An email’s subject line is akin to a headline in a newspaper article: To catch reader attention, it must be  relevant, interesting, and to the point. Before you send out your next email, don’t just tell people what it is with stale phrases like “coupon inside” or, “new product announcement”; consider what the email ultimately does for the recipient. In the case of a coupon, for example, telling them the actual dollar amount they stand to save—and presenting the coupon once they open the email may be more impactful to your click through rate efficacy. Even if you’re simply sharing great “insider” content, tease them with the ultimate “payoff,” whether the information is geared toward making them feel more beautiful, creative, healthy-- or more wealthy, in the subject line.
  2. Ask your readers what they think.  The fact that it’s free and easy to use isn’t the only reason that social media has become a powerful form of marketing for small businesses; it has everything to do with the fact that its two-way communication facilitates critical customer relationship building that leads to loyalty, and referrals. Instead of just delivering an email and telling them your message, think about ways you can get them involved, and invite them to share opinions on the topic of conversation to other social media channels like Facebook, Twitter, Pinterest or Instagram.
  3. Say less, show more.  You may have a lot you want to tell your audience—but consider using more white space, and fewer words. Additionally, using color to communicate a mood, and the desired call to action, can be an emotionally impactful way to reach readers through email. If your promoting a new line of product that involves exotic or exclusive ingredients, for example, enhance design elements in your email with purple to evoke such a mood. If the email message is practical in nature, such as apologizing for a customer service snafu or announcing a change in prices or policy, stick to grays, blues, and browns to communicate intellect and stability.  If you want customers to buy, integrating yellow and orange hues into email design communicates a carefree and airy mood.
  4. Take advantage of professional tools.  The key to effective email marketing as a small business is to have a strategy and purpose to your messages, including when you send them. Though you probably don’t want to bombard customers with emails every day, you’ll benefit by building some kind of predictability to your email releases, whether they arrive in the inbox every Sunday morning, Friday afternoon, or the first of each month. If you don’t have enough worthy content to share on a regular schedule (or the time to develop it), turn to technology! Scoop.it, a content curating publishing platform, recently announced a new functionality that works in tandem with the email marketing tool MailChimp, allowing you to create professional, magazine-worthy newsletters using a variety of content from sources you select from the web—in addition to the option to include your own proprietary posts and promotions. The best part? Both offer free basic subscriptions.

How The SBA Can Help You



The Small Business Administration will celebrate its sixtieth anniversary in July.  It was established as an independent agency of the federal government to help start new businesses and provide tools to help them grow.  It accomplishes its mission through direct action to counsel, aid, assist and protect small business interests.  It has formed partnerships with many public and private organizations, and maintains an extensive network of field offices to deliver its services throughout the United States.

The SBA has a wide array of assistance programs that focus on the four primary functions outlined below.

Business Financing

The SBA does not loan money directly, but establishes guidelines for loans with partner institutions that are guaranteed by the federal government.  As a general rule, the SBA only backs such loans if a business is unable to obtain other financing on reasonable terms.  Applying for an SBA loan is similar to applying for a standard commercial loan except there’s no risk to the lender.  Loan requirements may change as federal priorities and fiscal policies are adjusted to deal with current economic conditions.

The SBA has a program to guarantee surety bonds for businesses that can’t get them through normal commercial channels.  A surety is someone who assumes responsibility for paying the debt of another.  A surety bond is a three-party agreement where the surety assures completion of a project if the contractor is unable to perform successfully.  This program guarantees the surety that the SBA will cover a portion of any loss if the contract is breached.  This provides an incentive to sureties to provide bonding for contractors, increasing their opportunities to win contracts.  The bonds cover bid, performance and payment for contracts up to $5 million.  In limited cases, the bonds may cover contracts up to $10 million.

The Small Business Investment Company (SBIC) program engages private investment companies to provide venture capital for small businesses.  The SBICs have two sources of capital funding: government-licensed private investors and low-cost debt that’s guaranteed by the federal government.  SBICs are limited to investing in promising small businesses that qualify based on their need for equity or debt financing.

Federal Procurement

The SBA’s government contracting office has a statutory goal of awarding 23% of federal prime contracts to small businesses.  This office establishes goals with departments and agencies to achieve the overall objective of maximizing contract awards for these businesses.  It also sponsors outreach programs, training, and subcontracting opportunities.  The training includes detailed instructions on how to qualify for government contracts.

The SBA is heavily engaged with the Department of Defense and General Services Administration to create set-asides for small businesses in their contracts.  In addition, it maintains a national small business database that federal agencies can use to search for companies offering specific products and capabilities.  The Central Contractor Registry is a dynamic marketing resource for those seeking qualified small businesses.

There’s also a disadvantaged business development program to help businesses compete with non-disadvantaged small businesses on an equal basis.  This program has been expanded to include minority-owned and disabled veteran-owned businesses.

Advocacy

The Office of Advocacy is an independent voice for small businesses, advancing their views and concerns to all branches of the federal government.  Its operations are directed by the chief counsel who is appointed by the president.  The office reviews proposed Congressional legislation and its regulatory effect on small businesses.  It supplements these reviews with comprehensive research on the small business environment, using the results when testifying before federal and state governmental bodies and legislative committees. 

Advocacy attorneys seek the input of small business owners and work with federal agencies to determine how to minimize the impact of new laws and regulations.  They consider and analyze alternative policies and publish their findings for public comment.  They also work with state policymakers to promote regulatory flexibility and cost savings for small businesses.  The office publishes a quarterly report with small business performance indicators, small business profiles for all 50 states, and the Small Business Economy report.

Education & Training

The SBA counsels and advises small businesses at no charge through personal meetings and via the internet.  It also offers low-cost training programs designed to assist aspiring entrepreneurs and businesses that are already up and running.  Its training centers are spread throughout the U.S. in over 1,800 locations.  These programs provide financial management and technical assistance that are keys to successfully operating any business.

The SBA also maintains associations with private organizations such as the Service Corps of Retired Executives, now known as SCORE.  This nonprofit is dedicated to helping small businesses get started and grow through its mentorship and education programs.  Its membership is comprised of 12,000 volunteers who have business experience in 62 industries across the country.  Most services are provided free of charge or offered at a nominal cost.  These include personal mentoring, confidential counseling, business newsletters and tools, online webinars, and workshops at 348 local chapters.

Bottom Line

The scope and breadth of SBA programs far exceed the summary contained in this article.  Check sba.gov for the latest information regarding ongoing assistance programs and how you might qualify.  The SBA is a valuable resource that should be an early stop for startups and entrepreneurs with ideas for new businesses.  Their advice and support can help you get your business off the ground and increase your chances of success.


Geoffrey Michael (www.geoffreymichael.pro) is a freelance writer specializing in business, marketing, personal finance, law, science, aviation, sports, entertainment, travel, and political analysis.  He graduated from the United States Air Force Academy and is also licensed to practice law in California and New Hampshire.  Geoffrey wrote this feature article exclusively for DebbieMay.com, an organization dedicated to helping small businesses succeed.

You Want Success, So What’s Stopping You?


Is it possible that your thoughts can actually prevent you from being successful? Sure it is!

Your belief system dictates how you act, what you do, and the amount of emotional risk you are willing to take. In fact, I used to believe that if I ever became “successful” my life would change in ways that felt uncomfortable and undesirable to me.  And one day I realized just how limiting my subconscious beliefs had become.

While developing an exercise for one of my workshops it hit me that my image of successful people was, well, very limiting shall we say? I wasn't fully conscious of this image until then, and it sure kept me stuck!  After all, who would want to turn into some form of an unapproachable, unfriendly snob? {Laughing!} Yup, that’s what I believed; subconsciously at least.  

But how can a simple vision of an unappealing future keep me from success? And how did I know that it was, indeed, limiting my success? Well, I wasn't attracting enough clients, money was slipping through my fingers and I felt stuck and fearful about taking the risks associated with growing my business. Fear of unpleasant change can do funny things to a person; and I saw success as unpleasant!

So I took myself through my own process. That’s right: I walked the walk and talked the talk!

Below are some of the questions I asked myself to reveal my limiting beliefs. Before asking them of yourself, take a moment to think about where you might be stuck. Do you make excuses or procrastinate on certain things in your life or business? Do you feel uncomfortable when you imagine success in your life? Have you been spinning your wheels instead of making progress? These questions will help you to find out.

Think of one goal, desire or dream that you have not yet achieved and answer these questions:
  • What are the negative consequences that may occur when I achieve my desire? (You heard me right: negative consequences!) 
  • Who will I be when I achieve this dream or goal? What will change?
  • What will I expect of myself once I accomplish this goal?
  • What will others expect of me?
Your answers may provide insights around your limiting beliefs, but that's just the beginning.  How do we change these beliefs and knock down the seemingly impenetrable barrier to your success?

Sometimes the awareness alone is enough to create a break through, but as I found out in my next discovery, we need help to eliminate strong limiting beliefs. We can't always change with shear willpower because the things that keep us from moving forward are stored at the cellular level. That's right, the negative thoughts, worry, and stress can come from a level deep inside of us that we can't simply decide to change. These come from negative life experiences which are literally downloaded into our cellular memory. They become a part of who we are-- and letting go isn't always easy.

There are a few methods that address this problem; the method that I use in my life and as a coach is called The Emotional Freedom Techniques, or EFT Tapping. The success rate with EFT is very high and I find that its results are usually permanent.

Whatever method you choose, it's important that you understand that the procrastination, fear, and stress that comes from these embedded beliefs do not make us weak or inferior in any way. We all build walls around ourselves at some point in our life; it's just the way the human mind works. It's OK to reach out for help; breaking through the walls all by yourself is not easy. In fact, sometimes it's impossible.

Are you ready to create change, once and for all? Great! Hopefully the questions you’ve answered here will get you on your way. Again, once you make the decision to change, understand that you may need some “outside interference”. Coaches, therapists and successful mentors are all good resources. Try to avoid staying in the family and your circle of close friends; they love you too much to be objective.  

Go ahead. Shape those limiting beliefs into positive, uplifting images of a successful future, beginning now!

Marla Tabaka is an entrepreneurial coach who inspires entrepreneurs around the world to attain what she calls, The Million-Dollar Mindset. As a result, many of her clients have achieved – even surpassed – the million dollar mark in annual revenues and are living the life of their dreams. In addition to running a thriving practice, Marla is a columnist for Inc. Magazine on-line, and hosts two international on-line radio shows, The Million Dollar Mindset and Million Dollar Mindset Tapping. Marla wrote this feature article exclusively for Debbie May.com (http://www.debbiemay.com/), an organization dedicated to helping small businesses succeed. If you would like to consult with Marla to learn how she can help you grow your business and better your life, contact her at Marla@MarlaTabaka.com.