SPF Claim Support & Photobiology

In Vivo and In Vitro Methods, FDA, ISO, UVA, and UVB Testing, Photobiology and Photostability

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Published by our sponsorsSee case studies

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18-week hyperpigmentation study, NCT07136766 ↗

12-week eye cream study, NCT05807620 ↗

VISIA-CR imaging system in the VCS laboratory

SPF, UVB, UVA, and Visible Light Testing

Validated Claim Support can help support high volume static and Water Resistant output based on the multitude of various international standards currently available. Our partner network is extremely strong, and we work with domestic and foreign experts in photobiology.

Sun Protection Factor Testing (SPF) Explained

SPF is a highly regulated and sought after claim in the industry that represents a relative added protection factor offered by a consumer grade, OTC product against the UV radiation emitted from the sun.

As defined by Cancer.gov and the Center for Disease Control (CDC) the different UV radiation components are as follows:

UVA (315 to 400 nm) reaches deepest into the skin and is linked to skin aging and skin cancer. Broad spectrum claims rest on UVA protection.
UVB (280 to 315 nm) is the main cause of sunburn and plays a key role in skin cancer. SPF mainly measures protection against UVB.
UVC (100 to 280 nm) is absorbed by the ozone layer, so it does not reach the ground from sunlight. Exposure comes only from artificial sources such as germicidal lamps.

General UV Radiation Testing

Invisible rays are part of the energy that originates from the sun. Skin specialists recommend that people use sunscreens that allow protection of the skin from ultraviolet radiation. Ultraviolet A radiation also originates from special lasers or lamps and is utilized to treat particular skin conditions like vitiligo, psoriasis, and skin tumors of cutaneous T-cell lymphoma in medicine.

UVB Testing Services

UVB represents one of the most energetic wavelengths emitted from the sun, and is historically the main cause of reddening and inflammation after sun exposure.

Ultraviolet B radiation causes darkening, sunburn and thickening of the outer layer of the skin, and melanoma and other types of skin cancer. It may also cause problems with the eyes and the immune system, also referred to as UVB radiation.

UVB is the only wavelength that is tested in the traditional SPF in vivo analysis, and is determined with a comparison of treated skin to untreated skin with a controlled dose of radiation. The MED or Minimum Erythemal Dose as graded by a trained technician and the time it takes to become visible represents the SPF rating.

UVA Wavelength Implications

UVA is the most prevalent form of radiation that is not absorbed by the Earth’s ozone layer and magnetic field.

Ultraviolet A radiation also originates from tanning beds and sun lamps. Ultraviolet A radiation could cause premature aging of the skin & skin cancer. It might also cause problems with the immune system and the eyes. Skin specialists recommend that people use sunscreens that have their skin protected from ultraviolet radiation.

Although UVA radiation is weaker in comparison to UVB, it penetrates much deeper into the skin and is more continual throughout the year.

UVC Implications

UVC radiation is the highest energy portion of the UV radiation spectrum that is emitted from the sun. While UVC radiation from the sun does not reach the earth’s surface because it is blocked by the ozone layer in the atmosphere, that doesn’t necessarily make it any less dangerous.

We are still learning about the long- term effects of UVC exposure, and there is not a lot of documented research about how much makes it through the atmosphere. Additionally, there is little to no documented research about what products protect against UVC, and it is not currently tested for in any traditional SPF in vivo tests supported industry wide.

UV Testing Standards Supported

VCS can help support all major international standards including:

JCIA UVA
Current HDRS Hybrid Methods
Australia/New Zealand
Colipa Water Resistant and Very Water Resistant
ISO 24442, 24443, 24444
FDA Static, 40 and 80 min Water Resistant

Custom Protocol are available to test conditions like:

Wet Application
Towel/Abrasion Resistance
Sand Resistance
Salt Water
Chlorinated Water

Please note that the secondary claims noted above may or may not be approved by regulatory bodies throughout the world. Always consult your legal team when developing your claims.

Clinical photography camera in the VCS laboratory

Konica Minolta color measurement device in the VCS laboratory

In Vitro Claims (UVA and Broad Spectrum)

VCS and our collaboration with Helioscience allow us to offer a variety of UV analyzers at the in vitro level, and can help to support Broad Spectrum and UVA claims.

Helioscience will be offering a wide range of in vitro studies and then moving on to the newer HDRS hybrid methods as they start to become more industry standard.

We are aware that there is a belief that in vitro doesn’t correlate well to in vivo, and that’s always been based on the multitudes of different product types and the way some ingredients form films on PMMA plates.

The data that we’ve seen from Helioscience appears to have a very strong correlation, and the timelines are attractive. Of course, for the time being, a final in vivo test is needed for the SPF label claim, but if you were to do the UVA in vitro test first and screen SPF simultaneously during the road to a final formulation, this could be a great tool.

Helioscience is proficient with ISO 24442, 24443, and 24444 testing and also has in vitro models to demonstrate PA+ protection.

By measuring the absorption and transmittance of UV radiation through a PMMA or glass substrate with the product applied, it is possible to determine the UVA passthrough and thus the protection offered by individual products.

In vitro claim support can also help to provide some comparative data at the SPF/UVB level prior to engaging in vivo testing, although it is important to note that In Vitro UV data is not recognized by any international regulatory authorities at this time.

Water Resistance Testing and Claim Support

VCS maintains a custom developed spa/water resistance lab with 8 individual treatment tubs. All tubs have been customized with in line continuous heating and water flow parameters traceable to international standards.

All 8 VCS tubs are single capacity to ensure accuracy and hygiene.

Secondary Clinical Studies Training

Onsite SPF and UVA training conducted by Dr. Curt Cole (President, Sun and Skin Consulting) and Solar Light Company, America’s premier manufacturer of Precision Lightsources and the inventor of the first Solar Simulator in 1967.

https://solarlight.com

Phototoxicity Testing Services

A method designed to determine the UV degradation/alteration of a given product when applied to the skin. Phototoxicity presents a serious concern when products are designed to be warn in just about any climate throughout the world. Pairs immediate irritation testing (24/48 hour patch) with UV exposures.

For products that are designed for long term or pediatric use, it is imperative to determine that products don’t break down and cause irritation after continued exposure to the sun or secondary UV radiation.

Calibrated skin measurement probes in the VCS laboratory

Product applied to forearm test sites in a photo-allergy study

Photo-Allergy Maximization Clinical Studies

A more involved method that effectively pairs continuous application, repeat insult patch testing and multiple UV exposures. Photo-Allergy Maximization is more robust than Phototoxicity and incorporates sensitization/allergenic potential as well as UV exposures.

This provides a measure of the most demanding aspects of both Repeat Insult Patch Testing along with a continuous UV exposure to simulate the effect of the sun on a product over time.

As per CDC Guidelines, SPF is Not Necessarily Enough

Avoid Indoor Tanning. Indoor tanning is dangerous particularly, for younger users; people who start indoor tanning throughout early adulthood or adolescence have a higher risk of developing melanoma.
Use sunscreen with sun protection factor (SPF) 15 or higher, for both UVA & UVB protection.
Wear wrap around sunglasses that block both UVB and UVA rays.
Wear a wide-brim hat to shade your neck, face, head, and ears.
Consider options to protect your children.
Wear clothes that cover your legs and arms.
Stay in the shade, especially throughout midday hours.

Clinical photography

Before & After Photography: Custom Teaneck NJ Studio

Clinically Validated, High Resolution Before and After Images and Analysis Over Time. Validated Claim Support uses high-resolution clinical photography to document how a product performs over a treatment timeline or product usage cycle.

See our before and after photography Get a quote See the gallery

BaselineWeek 2

Redness reduction: 44% less redness from baseline to week 2. The lower circle shows the average skin color in the treated area. Drag to compare.

Before and after case studies

Hair Growth Efficacy And Clinical Density Improvement →

Hair Density And Hair Growth Clinical Imaging Side Profile →

Acne lesion, baseline compared with result

Full Face Acne Reduction Lesions With Analysis →

Dry Scalp And Dandruff Improvement Clinical Study Photo →

Anti-Aging, Wrinkle Reduction And Clinical Claim Support Imaging →

Full Face Before And After Anti-Aging And Fine Line Reduction →

Pore Size Reduction Clinical Photograph →

Blemish redness, baseline compared with day 3

High Resolution Redness Reduction →

Expert Clinical Grading

Trained graders score visible change

Supports claims like “Clinically proven to reduce the appearance of fine lines and wrinkles”

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Biomarkers and Microbiome

Tape strips, swabs and collections

Supports claims like “Microbiome friendly” and “Won’t disrupt the skin’s natural microbiome”

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Biophysical Instrumentation

Hydration, TEWL, elasticity, color

Supports claims like “Hydrates by up to 87% in as little as one use”

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Peer-Reviewed Writing

Clinical and scientific publications

Scientifically validated study summaries for publication in peer-reviewed medical journals

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Before and After Photography

Controlled, reproducible clinical imaging

Supports claims like “Up to a 44% reduction in redness in as little as 2 weeks”

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Consumer Perception

Panelist questionnaires and self-assessment

Supports claims such as “97% of women agreed their skin felt smoother and more supple”

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Where to next

Keep exploring

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Tell us about your product, your intended claims, and your timeline. Our business development team will review your needs and follow up with a customized proposal, typically within one business day. There is no cost for the initial consultation or study design review.

Get a quote Call (201) 331-9300

FAQ

SPF Testing: frequently asked questions

What SPF and sun care testing does Validated Claim Support offer?

Validated Claim Support refers SPF and sun care testing to its partner photobiology labs: Normec Schrader Institute, HelioScience and KosmoScience. Through those partners, brands can support SPF, UVB, UVA and visible light claims using in vivo and in vitro methods, including static and water resistant SPF, broad spectrum and UVA testing, photobiology and photostability. VCS makes the introduction to the right lab for your project.

How is SPF measured in an in vivo test?

UVB is the only wavelength tested in the traditional in vivo SPF analysis. Treated skin is compared with untreated skin under a controlled dose of radiation, and the minimal erythemal dose, or MED, graded by a trained technician, together with the time it takes to become visible, determines the SPF rating.

Which international SPF standards can VCS support?

Validated Claim Support can help support all major international standards, including FDA static and 40 and 80 minute water resistant, ISO 24442, 24443 and 24444, Colipa water resistant and very water resistant, Australia and New Zealand, JCIA UVA and current HDRS hybrid methods.

How does VCS test water resistance?

Validated Claim Support has a custom-built spa and water resistance lab with 8 individual, single-capacity treatment tubs, each with in-line continuous heating and water flow parameters traceable to international standards. Custom protocols can test wet application, towel and abrasion resistance, sand, salt water and chlorinated water.

Can in vitro testing replace in vivo SPF testing?

Not for the SPF label claim. A final in vivo test is still needed, and in vitro UV data is not recognized by any international regulatory authority at this time. In vitro testing with Helioscience is useful for broad spectrum and UVA claims, PA+ models, and screening SPF while a formulation is still being developed.

What are phototoxicity and photo-allergy testing?

Phototoxicity testing pairs 24 or 48 hour patch irritation testing with UV exposure to check that a product does not break down and irritate the skin in the sun, which matters for long-term and pediatric products. Photo-allergy maximization is more robust, combining continuous application, repeat insult patch testing and multiple UV exposures to measure sensitization potential.

Who trained the VCS team on SPF and UVA testing?

Onsite SPF and UVA training for Validated Claim Support was conducted by Dr. Curt Cole, President of Sun and Skin Consulting, and Solar Light Company, the manufacturer of precision light sources that invented the first solar simulator in 1967.