Formulate Clean SPF

SPF is an essential part of an effective skincare routine. As you may know, sun (UV) rays cause permanent damage to skin and accelerate the process of skin aging. Besides skin cancer, UV exposure from the sun causes wrinkles and hyper-pigmentation, which are effects we typically try to reverse with skincare products.

While using moisturizers and a variety of skincare serums can help to reduce the signs of aging, the best way to prevent wrinkles and hyper-pigmentation in the future is to wear sunscreen (Source)! 

Since sunscreen is so essential, you may be thinking about formulating your own clean SPF product and selling it on the market. In this blog we will go into what ingredients to use and not to use in your clean SPF formulation as well as the benefits (and drawbacks) of formulating a clean SPF product. At the end, we will get into what services Genie Supply offers for individuals trying to create their own skincare product. Let’s go!

Why should you use “clean” SPF? 

Clean is a common term used in the skincare industry meaning a product is a product that is safe, non-toxic, and has transparent labeling of ingredients. There are different clean standards used; mainly Clean at Whole Foods, Clean at Sephora, and Clean at Credo. For more information on the different clean standards check out the “What is Clean Beauty?” tab on our website. 

In terms of SPF, is it important to use a clean formula as many SPF products are not clean and can cause damage to your own skin and the environment as a whole! Since SPF is meant to be applied everyday it is important to choose an SPF that does not contain any harmful ingredients. Some unclean active ingredients such as oxybenzone, octinoxate, and octisalate, soak into the skin and cause health complications in the future.

Octinoxate, for example, can cause hormonal imbalances specifically in adolescent aged individuals, and has been found to be harmful to aquatic life (Source). This  is even more troubling given the fact that most people apply SPF when visiting the beach (where aquatic life lives).

These are just a few disadvantages to using unclean SPF ingredients, and there are many more! For a comprehensive look at the danger of unclean active SPF ingredients check out the Environmental Working Group’s Sunscreen Guide.  

Ingredients to Use and Not to Use

As mentioned above, oxybenzone, octinoxate, octisalate, octocrylene, homosalate and avobenzone are all harmful active ingredients in sun protection products that can cause harm to the user and the environment when used (Source). 

For this reason it is important to choose a clean active ingredient for your SPF, the most commonly researched and verified non-toxic active ingredients for sun protection are titanium dioxide and zinc oxide.

These are both mineral sunscreens, as opposed to chemical sunscreens, that soak into the skin at much lower rates and cause substantially less damage to the user and the environment (Source). 

One issue with these ingredients to be wary of is when used in sprays inhalation of these ingredients can be cause for concern, but when applied topically they have been classified as safe and effective by the FDA (Source). 

Formulating SPF Special Characteristics

Although SPF is considered skincare, there are much stricter regulations when formulating with SPF due to the fact that it is considered an over-the-counter drug by the FDA.

SPF can be included in moisturizers and many other skincare products, however this makes the formulating process much more complex and costly. If you are up for the challenge, however, it may be the perfect product for you to formulate!

There are a few special characteristics to formulating and selling SPF product due to their over-the-counter drug status. Below we will get into the special considerations and processes involved in formulating and selling an SPF product:

• FDA Labeling Regulations

  First, the FDA offers guidelines which the label must follow in accordance with FDA regulation  21 CFR 201.327 (Source). This includes displaying the strength of the SPF in the ingredient (ex: SPF 50), directions, uses, and warning somewhere visible on the label.

  These sections, obviously, must be completely truthful and have evidence backing up the claims.

  The labels must first be approved by the FDA before being released to market, which can cost time and money during the formulating process. The FDA offers a great resource outlining exactly what the label must be included on the label.

• Subject Patch Testing

  Also all SPF products must pass a series of tests proving their efficacy and safety of use. The product must be tested on a minimum of 10 individuals in a professional testing facility with tests being performed on an at least a 30 cm2 area of the back with many other specifications for application during testing such as application sites being at least 8cm apart (Source). 

• SPF Testing

  Another test that must be performed on an SPF product before being released to market, in accordance with FDA guidelines, is the broad-spectrum test. This test measures a sunscreen drug product’s transmittance/absorbance of ultraviolet (UV) radiation across both the UVB and UVA regions of the spectrum.

  This test, similar to subject testing, has many specifications for how the testing is performed and what results constitute an SPF product ready to be released to market (Source). 

Keep in mind that it is not uncommon for a product to fail 1 or more of the tests needed for the product to be approved by the FDA. In this case the formulator must “go back to the lab”, as some would say, and adjust the formulation to meet FDA regulations.

Each time the formula is adjusted it must go back through the entire testing process, even if it passed one of the tests previously. This can quickly increase costs as 1 round of SPF effectiveness testing can cost $4500 US dollars and 1 round of subject testing can cost $3000 US dollars. 

One way to mitigate these costs is to perform patch testing on a small group of subjects to see if it performs well before paying the full cost of a full panel of subjects, however this may extend the timeline of developing the product. 

In total, you can expect to spend:

• $5,000 - $50,000 on R&D

• $10,000 - $25,000 on testing

• $100,000+ on manufacturing (most manufacturers have 25k unit mins/formula)

Too Pricey? Not Ready for SPF formulation? Start off With Basic Skincare and Work Your Way Up!

Clean SPF is a good choice to formulate or custom label if you have the time and money, and patience for it. SPF formulations are commonly more expensive because of the testing and other complex processes that must be used to create an SPF product that is safe and legal to take to the market.

While SPF is essential and a product that can, and should, be used with a wide variety of skin types, it is also difficult to introduce an SPF product to market, especially if you have limited time and money. 

If SPF doesn't feel right for you right now due to time and budgetary constraints, you could  try formulating your own non-SPF product for substantially less input costs.

Genie Supply offers a wide variety of custom formulating services that can be used to help create a custom formula for you, for a lower cost than an SPF product.

Check out our custom formulating page to get more information on custom formulating at Genie Supply, and even book a free 15 minute consultation with one of our sales representatives about your product idea! 

If custom formulating is also out of your price and time range we always recommend that individuals new to the market check out private labeling options as well! With private labeling at Genie Supply, we have already done the hard work for you by formulating and testing all of our private label formulas so they are ready to be manufactured (only after you place your order) and sent out for you to sell!

When you private label with Genie Supply,  you can start off by ordering only 500pcs, which can help get you familiar with the market without spending too much money on your first launch! For more information on private labeling with Genie Supply, check out our Private Label page or order samples to try out the products for yourself! 

Questions? Comments? Feel free to reach out to us at customerservice@geniesupply.com or give us a call at 812-329-1105.