FDA announces new requirements for over-the-counter (OTC) sunscreen ...............

[Chris Ryser]

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in fourregulatory documents that include a Final Rule, a Proposed Rule, an AdvanceNotice of Proposed Rulemaking, and a Draft Guidance for Industry.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Q11.What is included in the Draft Guidance for Industry?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

[chip anderson]

Kind of wish they had UV in side windows of cars, having just had an ugly squamous cell carcinoma removed from my left arm. Not to mention some skin cancers show up on the left side of my head. Doctors say this is from sun hitting left side in the car.
Until now I have concidered UV filters be so much BS.

Chip

[rinselberg]

Shops that tint car windows.. think they can put a UV film on side windows that won't darken your view.

[chip anderson]

Unfortunately, the good doctor said the problem occured about 50 years ago and finally came to fruation. Don't think UV was concidered a danger 50 years ago.

Chip

[Chris Ryser]

Unfortunately, the good doctor said the problem occured about 50 years ago and finally came to fruation. Don't think UV was concidered a danger 50 years ago.

50years ago..............UV was considered a danger at high altitudes that could induce snow blindness or keratitis. We used to sell skigoggles with leather side shields and very dark round glass lenses.

Keratitis is the medical term for inflammation of the cornea. The cornea is the dome-shaped window in the front of the eye. When looking at a person's eye, one can see the iris and pupil through the normally clear cornea. The cornea bends light rays as a result of its curved shape and accounts for approximately two-thirds of the eye's total optical power, with the lens of the eye contributing the remaining one-third.. Only the very thin tear film lies between the front of the cornea and our environment.

The cornea is about 0.5 millimeter thick. The back of the cornea is bathed in the aqueous fluid that fills the anterior chamber of the eye. The cornea has a diameter of about 13 millimeters (½ inch) and, together with the sclera (the white part of the eye) forms the entire outer coat of the eye.

50 years ago..................we also sat on front of home UV lights to keep healthy and get a little tan and get a heathy body by the influence of UV

only a few years ago..................OptiBoarders still told me on several occasions all this bit about UV was BS and unimportant.