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Summary of Key Points on Over-the-Counter Sunscreen Products
FDA is proposing a new regulation that sets standards for formulating, testing and labeling over-the-counter (OTC) sunscreen drug products with ultraviolet A (UVA) protection.
- May 1999. FDA published final rule setting standards for formulating, testing, and labeling of over-the-counter (OTC) sunscreen products that protect against ultraviolet B (UVB) rays, which cause sunburn.
- Regulations concerning UVA were delayed until reliable testing methodologies could be developed.
- UVA and UVB rays comprise the ultraviolet light that is emitted from the sun. Both rays contribute to premature skin aging, skin cancer and other skin damage.
- August 2007. FDA proposes new sunscreen regulations that focus on sunscreen protection from UVA light. The proposed regulations address manufacturing, testing and labeling of UVA sunscreens.
- UVA proposed rule introduces consumer-friendly, four-star rating system that would rate the level of UVA protection from “low” ( one star) to “highest” ( four stars). For example, a sunscreen product providing medium UVA protection would be labeled like this:
- Sunscreen products found to provide no UVA protection would be required to be labeled “No UVA Protection” upfront, near the SPF value.
- Under the August 2007 proposed rule, the UVA protection rating of a sunscreen would be determined by conducting two tests. One test will determine a sunscreen’s ability to reduce the amount of UVA light that passes through it, and the other test will determine a sunscreen’s ability to prevent tanning. The results will be combined to generate a single UVA rating, which will be the lower of the two values.
- For the first time, under the proposed rule, manufacturers would be required to print a Warnings statement in the Drug Facts box that reads:
UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen.
- The proposed rule renames “SPF” from “sun protection factor” to “sunburn protection factor,” which is the rating for UVB protection.
- Under the proposed rule, sunscreen product labels would be required to include “UVB” alongside “SPF” so that consumers know that SPF values reflect UVB sunburn protection.
- Under the proposed rule, SPF values would increase from SPF 30 to SPF 50+. SPF values higher than SPF 50 can not be substantiated with current, available testing methods.
- Under the proposed rule, sunscreen product labels would direct consumers to apply sunscreens “liberally” or “generously” and to reapply frequently, at least every two hours, “to avoid lowering protection.”
- The rule will allow manufacturers to formulate their products with avobenzone in combination with either zinc oxide or ensulizole.
- Because of the potential risk of nanoparticle ingredients penetrating consumers’ skin, FDA is soliciting public comment on the safety and effectiveness of sunscreen ingredients formulated in particle sizes as small as a few nanometers.
- FDA is also inviting public feedback on appropriate ways to test the effectiveness of novel sunscreen dosage forms, including mousses, foams, sprays, and towelettes.
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Date created: August 23, 2007
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