US FDA announces final rule on sunscreen labeling

Brianne Rothrock
Suncare Research Laboratories, LLC
July 2011

Like in many years before, as the dawn of summer 2011 approached, consumers were left to their own devices to decide which sunscreen products are most effective. With manufacturers, dermatologists, politicians, scientists, advocacy groups and the media all contributing their own sometimes conflicting opinions, the consumer has been left in the dark in determining which products are truly effective.

That is until 10am on June 14, when the FDA held a press conference to announce the much anticipated regulations on sunscreens. The FDA’s announcements included:

• A Final Rule for sunscreen labeling and testing;
• A Proposed Rule;
• An Advance Notice of Proposed Rulemaking (ANPR) for Dosage Forms; and
• A Draft Enforcement Guidance for Industry.

Final Rule for Labeling

Sunscreen products that meet the current standards for effectiveness can now be labeled with information that assists consumers in selecting the best products that, when used with other sun protection measures, help prevent sunburn as well as reduce the risk of skin cancer and premature skin aging. The final regulation allows for sunscreen products that pass the FDA’s test for protection against both ultraviolet A (UVA) and ultraviolet B (UVB) rays, which both contribute to sunburn, skin cancer, and premature skin aging, to be labeled as “Broad Spectrum.” Under the new standards for labeling, sunscreens that meet the criteria for both “Broad Spectrum” labeling and have a SPF of 15 or greater, can claim that “sunscreen reduces the risk of skin cancer and early skin again when used as directed” (U.S. FDA). Manufacturers must comply with these label changes by June 2012.

Other important label changes address application and water resistance. Now, regardless of the formula, no label can contain the terms “waterproof,” “sweat proof,” “sunblock,” or “all day protection” (U.S. FDA).  Now, labels must also state the time (40 or 80 minutes) that the product remains water resistant and that reapplication is required every two hours. The improved, informative Drug Facts Box and new product labeling are a welcome improvement.  

Changes in Testing

Testing requirements for UVA protection claims have also been revised. In vivo UVA testing is no longer required; and the four star UVA labeling system and descriptors have been done away with. A simple critical wavelength spectrometer reading has replaced the previous extensive in-vitro UVA testing. Procedures for SPF testing have also been modified. The required number of test subjects has been dropped from 20-25 to 10.

The Proposed Rule, ANPR, and Draft Enforcement Guidance for Industry

In addition to the final rule on sunscreen labeling, three additional important regulatory documents were released. The proposed rule would limit the maximum SPF value to “50+” on sunscreen labels because there is no significant data to demonstrate that products with SPF values greater than 50 provide better protection for consumers than products with a SPF value of 50. According to Shelly Burgess of the FDA, the ANPR “will allow the public a period of time to submit requested data addressing the effectiveness and the safety of sunscreen sprays and to comment on possible directions and warnings for sprays that the FDA may pursue in the future, among other issues regarding dosage forms for sunscreens.” The Draft Enforcement Guidance for Industry provides information to assist sunscreen product manufacturers understand how to properly test and label their products in accordance with the new final rule and other regulations.

Despite various media claims that sunscreens cause vitamin D deficiency and assorted other dangers that leave us vulnerable to medical problems and cancers, there is no evidence that sunscreen causes any adverse effects. According to Warwick Morison, MD, MB and Steven Wang, MD,  “When used as directed, [sunscreen] can reduce the risk of actinic keratosis, the most common skin precancer, and squamous cell carcinoma, the second most common skin cancer” (Morison). The jury is still out on basal cell carcinoma and melanoma, the most deadly form of skin cancer. Because current sunscreen products have been on the market for many years without proven danger, the FDA does not have any reason to believe that these products are not safe for consumer use. However, the FDA is currently re-examining the safety information that is available for active ingredients in current sunscreen products.

The Sunscreen Labeling Protection Act of 2011

The FDA’s announcement came after many years of years of pressure from six U.S. senators. In a May 25 letter to Commissioner Hamburg and Director Lew of the FDA, Senators Jack Reed (RI), Tom Harkin (IA), Charles Schumer (NY), John Kerry (MA), Patrick Leahy (VT), and Kirsten Gillibrand (NY) urged the FDA to release the final monograph that they promised to release by Fall of 2010. The primary concern of the senators’ letter, urging for “clearly and accurately labeled sunscreen products, containing comprehensive information that includes UVA and UVB protection,” was, surprisingly enough, what the FDA delivered just shy of a month later (Reed).  Senator Jack Reed has served as the leader of the cause, pressuring the FDA to “finalize [the] monograph without further delay so that Americans will no longer be deceived into thinking they are truly protected from the sun when that isn’t the case” (Reed). Reed released a statement June 14, the day of the FDA’s press conference, saying, “This is a victory for consumers that is long overdue…These new sunscreen standards are going to give consumers better, more accurate information” (Reed).

The FDA’s final rule on labeling, however, did not satisfy the senators in their quest for a final rule on sunscreen products.  On the same day as the release of the letter to the FDA, Senators Reed, Schumer, Kerry, Leahy, and Al Franken (MN) submitted a bill to “make effective the proposed rule of the Food and Drug Administration relating to sunscreen drug products, and for other purposes” (US Congress). If passed, the SUN Act will make the FDA’s proposed rules become law 180 days from passage of the Act, unless the FDA issues the final rules.

References:

“Labeling and Effectiveness Testing; Sunscreen and Drug Products for Over-the-
Counter Human Use (Final Rule).” Federal Register 76.117 1-15. Web. 05 Jul
2011.

Morison, Warwick L. and Wang, Steven Q. “Sunscreens: Safe and Effective?” The Skin
Cancer Foundation Journal. 29 (2011): 55-58.

Reed, Jack. “After Years of Prodding from Reed, FDA Strengthens Sunscreen
Standards.” 14 Jun 2011. Senator Jack Reed. Web. 08 Jul 2011.

Reed, Jack; Harkin, Tom; Schumer, Charles; Kerry, John; Leahy, Patrick; Gillibrand,
Kirsten. Letter. 25 May 2011. United States Senate. Print. 08 Jul 2011.

Shaath, Nadim. "Finally...The Final Rule On Sunscreen Labeling." The Sunscreen Filter.
Household And Personal Products Industry, July 2011. Web. 05 July 2011.

United States. Cong. Senate. 112th Congress, 1st Session. S.1064, Sunscreen Labeling
            Protection (SUN) Act of 2011. 112th Cong, 1st sess. Congressional Bills, GPO
            Access. Web. 08 Jul 2011.

United States Government. Food and Drug Administration. FDA Announces Changes to
            Better Inform Consumers About Sunscreen. U S Food and Drug Administration
            Home Page. US Food and Drug Administration, 14 June 2011. Web. 06 July
2011.

UVA Protection: An Update

Joe Stanfield
Suncare Research Laboratories
December, 2010

UVA Radiation
The longer ultraviolet wavelengths in sunlight are known as UVA radiation (320-400 nm). Until a few years ago, the shorter wavelengths, known as UVB (290-320 nm), were considered the most important contributor to skin damage resulting from excessive sun exposure. New studies have provided evidence of greater UVA involvement in skin tumor development, suppression of immune function and premature aging, than previously realized. [1]

UVA comprises 90-95% of terrestrial radiation, and penetrates deeply into the dermis, whereas the shorter UVB wavelengths, are up to a thousand times more effective in producing sunburn, but penetrate the more superficial epidermis only. UVB is associated primarily with damaging to cellular DNA, while UVA damages DNA to a lesser extent, and is primarily associated with indirect damage to skin cells through production of free radicals. Sunlight is always a mixture of UVA and UVB, and laboratory tests that separate the effects of UVA from those of UVB can distort the relative importance of UVA protection. Perhaps the most important reason for "balanced" UVA and UVB protection is to assure that sunscreen products protect over the broad range of solar spectra that occur with varying sun angles due to latitude, season and time of day. [2]

The new marketed sunscreen products, with SPFs up to 100 offer vastly improved protection against solar UVA, as well as UVB, yet the FDA has not published a Final Rule for SPF labeling or UVA protection labeling.

Recommendation of the European Communities (EC)
In 2006 the Commission of the European Communities (EC) recommended that sunscreen products have a UVA protection factor (UVAPF) that is at least 1/3 the SPF and a critical wavelength [3] of at least 370 nm.[4] The Commission also endorsed the use of in vitro methods for measuring the UVA protection factor. The European Cosmetics Association (Colipa) has since published a Guideline for in vitro measurements of the UVAPF/SPF and critical wavelength. [5]

UVA Protection Test Methods
Earlier proposed methods, in addition to the Critical Wavelength, include the persistent pigment darkening (PPD) test [6] and the Boots Star Rating, which is still used in the UK. [7] The Critical Wavelength method proposed by Diffey requires mathematical integration of the in vitro product absorbance spectrum from 290 to 400 nm to determine the wavelength below which 90 percent of the cumulative area of the absorbance curve resides. If the Critical wavelength is 370 nm or greater, the product is considered "broad spectrum," which denotes balanced protection throughout the UVB and UVA ranges.

Persistent Pigment Darkening (PPD) Test
The PPD test is a laboratory evaluation on human subjects that yields the ratio of the UVA dose required to produce a defined skin darkening response (Minimal Persistent Pigment Darkening Dose, MPPDD), with and without a sunscreen product on the skin. The response is evaluated 2 to 4 hours after administration of UV doses. The ratio of the MPPDD with the sunscreen product on the skin to that without the sunscreen is called the UVAPF, or the PFA.

The PPD test produces rapid results with moderately low doses of UVA. Product UVA protection may be categorized based on the UVAPF. The PPD response is stable and reproducible; however its clinical significance is questionable, because the action spectrum for PPD is not defined for wavelengths shorter than 320 nm, and the response is masked during outdoor sun exposure by other skin responses to UV. Thus it is impossible to relate the PPD protection factor directly to the degree of protection is sunlight.

Boots Star Rating
The Boots Star Rating [7] involves in vitro measurement of the product absorbance spectrum and calculation of a ratio of average UV absorbance to average UVB absorbance. The ratio is used to assign products among 3 categories of "broad spectrum," protection, denoted by stars. (Now 3 to 5 stars, depending on the UVA/UVB ratio before and after irradiation with a UV dose of 17.5 J/cm2.

FDA Star Ratings
The FDA does not permit a numeric UVA protection at present. On August 27, 2007, the FDA published a proposed Sunscreen Monograph Amendment (8) that outlines a UVA rating system based on "stars" similar to the Boots Star Ratings (See above). To label a product with one or more stars, the sunscreen must be tested on 20 human subjects for protection against PPD (See above). The proposed ratings are as follows:

• For one star (Low) the UVAPF must be 2 to under 4.
• For 2 stars (Medium)the UVAPF must be 4 to under 8.
• For 3 stars (High) the UVAPF must be 8 to under 12.
• For 4 stars(Highest) the UVAPF must be 12 or more.

• For 1 star (Low) the ratio must be 0.20 to 0.39.
• For 2 stars (Medium) the ratio is 0.40 to 0.69.
• For 3 stars (High) the ratio is 0.70 to 0.95
• For 4 stars (Highest) the ratio must be greater than 0.95.

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2. Lim H, Rigel D. UVA: Grasping a better understanding of this formidable opponent. Skin & Aging. 2007;15:62-67.
3. BL Diffey. A method for broad spectrum classification of sunscreens. Int J Cosmet Sci 16:47-52, 1994.
4. The Commission of the European Communities. Commission Recommendation of 22 September 2006 on the efficacy of sunscreen products and the claims made relating thereto. Official Journal of the European Union, L265/39, 26.9.2006.
5. In vitro UV Protection Method Task Force, In vitro method for the determination of the UVA protection factor and critical wavelength values of sunscreen products, Colipa, 2009.
6. Chardon A, Moyal D, Hourseau C. Persistent pigment darkening as a method for the UVA protection assessment of sunscreens. In: Protection of the Skin Against Ultraviolet Radiations, Rougier A, Schaefer H, eds. John Libbey Eurotext, Paris 1998, pp. 131-136.
7. Measurement of UVA:UVB ratio according to the Boots Star rating system (2008 revision). Boots UK Limited, Nottingham, NG2 3AA, UK. January 2008.
8. U. S. Food and Drug Administration. Sunscreen Drug Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph; Proposed Rule; 21CRF Parts 347 and 352. Federal Register 72 (165) August 27, 2007. 49070-49122.
9. Sayre R, Dowdy J. Photostability Testing of Avobenzone. Cosmetics & Toiletries. 1999;114 (1):85-91.
10. Sayre R, Dowdy J,Gerwig A, Shields W, Lloyd R. Unexpected photolysis of the sunscreen octinoxate in the presence of the sunscreen Avobenzone. Photochem Photobiol, 2005;81:452-456.
11. Bonda C, Pavlovic A, Hanson K, Bardeen C. Singlet quenching proves faster is better for photostability. Cosmetics & Toiletries 2010;125(2): 40-48.