Questions andAnswers: FDA announces new requirements for over-the-counter (OTC) sunscreenproducts marketed in the U.S.
On June 14, 2011the U.S.Food and Drug Administration (FDA) announced new requirements for sunscreenscurrently sold over-the-counter (OTC) (i.e. non-prescription). Theserequirements support the Agency's ongoing efforts to ensure that sunscreensmeet modern-day standards for safety and effectiveness. The new requirements,as well as several proposed changes for future rules, are outlined in fourregulatory documents that include a Final Rule, a Proposed Rule, an AdvanceNotice of Proposed Rulemaking, and a Draft Guidance for Industry.
The following questions and answers providea brief overview of the recent regulatory actions and highlight the mostimportant information for consumers to know when buying and using sunscreenproducts.
Q1.Why is FDA making changes to how sunscreens are marketed in the United States?
Q2.When will these changes take effect?
Q2.When will these changes take effect?
A. The Final Rule will take effect by the summer of 2012, butconsumers may begin to see changes to sunscreen labels before the effectivedate.
Q3.What does the SPF value on sunscreen labels indicate?
Q4.Does FDA believe sunscreens are still safe and effective? Do consumers need tothrow away the sunscreens they are currently using?
Q5.What do consumers most need to know when buying and using sunscreens?
Q6.What are the main points of the new Final Rule?
Q7.Does the Final Rule apply to cosmetics and moisturizers containing sunscreen?
Q8.What does the Proposed Rule address?
Q9.What is the purpose of the Advance Notice of Proposed Rulemaking (ANPR)?
Q10.Why is the Advance Notice of Proposed Rulemaking (ANPR) requesting additionaldata on sunscreen products in the form of sprays?
Q11.What is included in the Draft Guidance for Industry?
Q12.Why isn't FDA finalizing all the proposed sunscreen changes under one rule?
Q13.Where can I find more information on these various regulatory actions?
Q14.Where can I find more information on sunscreen use?
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingOver-the-CounterMedicines/ucm258468.htm
Sunscreen
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingOver-the-CounterMedicines/ucm239463.htm
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