Friday, July 29, 2011

Sunscreens now can not claim that they are water proof

New regulation for sunscreen products will be in effect in one year.

On 29-Jul-11 united states department of health and human services issued a note that now sunscreens marketed in the country must not claim as “water proof”, “sun block “ or may not claim sun light UV protection immediately after application or instant protection .The new proposed regulations about sunscreen products will be effective in a year.
The fact is that all sunscreens products tend to get washed out when they come in contact with water after some time, some formulations do sustain in water but not for the time the user feels after reading the term “Water resistant”, which makes user susceptible for sunburn and premature aging of skin , skin flare and sunburn , urticaria due to sunburn and skin cancer.

Sunscreen manufacturers may claim the product as water resistant but the product label is required to mention that the product is water resistant for how much time it remains after a contact with water, the such time will have to be derived from the actual experimental data (also see clinical trials), and a clear direction for its re application in event it get washed off in water will be now required to be mentioned on the product label.

Us FDA has also provided guidelines for consumers, it mentions that consumers should read the label carefully all the back label as well as front label for the details and to decide which product is best suitable. The new regulations will include following point so as to provide consumer better protection form sunburn and skin cancer due to exposure to sun light they include.

1.The label mentioning or reflecting the actual conditions which will help get the desired effect based on the test results by establishing standard for testing effectiveness of the sunscreen product .

2.It will be proposed to limit the higher limit of a sunscreen to sfp 50+.

3.Safety and efficacy data will be asked from manufacturers in case of the product is accidentally inhaled and as in case of sprays ,

4. Guidelines will be issued to manufacturer for how to test and label the product so as to comply the new regulations on sunscreen products.

The guidelines will decide which sunscreen product can be termed as broad spectrum depending up on the sun light protection (the product which will provide protection from both UV A as well as UV B radiation) ( broad spectrum and SPF 15).

The sunscreen product with SPF from 2 to 14 will be required to provide a warning on the for possible sunburn , and warning about skin cancer from sunlight light.

What is sunscreen product:
When our skin is exposed to sun, the sun rays can induce burns and damage the skin, UV B rays in the sun rays are capable of burning and inducing damage to DNA , which may cause skin cancer, therefore it is required that we protect our skin while our body is exposed to sun rays , specially on the beaches and while swiming and out door activities which requires one to work under sun light.

Chemical sunscreen agent:
Some products are developed to provide protection from sunlight and UV light , they contain a ingredients which are able to absorb the harmful radiation in the sunlight the by protecting our skin from its harmful effect, these chemicals are termed as chromophores, which contain a peculiar double bonds in the molecule which absorb UV light and protect the covered surface from UV light.
Examples of chemical sunscreen agents are
Avobenzone , Homosalate, Octyl methoxycinnamate

Formulating them in different composition provide different range of SFP values.
Physical sunscreen agents:
They consist of ingredient which hinder or occlude sun light physically from reaching the surface of the skin up on application, example is titanium dioxide, zinc oxide.
Measurement of efficacy of UV light protection:

1.Sun protection factor (SPF)
Sun protection factor is one of the measure used to rate the ability of a sunscreen agent to provide protection from harmful effect of sunlight and UV light, a sun protection factor SPF of 15 and more is considered to be a good sun protective agent. In this method UV-B range wavelength 290–320 nm is used to find out the sun protection factor SPF. In this method time required to produce erythema or reddening on skin up on which a sunscreen agent is applied is measured, with a control.

2.Persistent pigment darkening (PPD):
Sunlight also contain UV-A Range wavelength 320 to 400 nm which do not cause apparent skin damage but is of great importance as it may cause DNA damage and skin cancer therefore in this method of evaluation of sunscreen agent by persistent pigment darkening (PPD) in this method a sunscreen is tested for its efficacy against UV-A Range wavelength 320 to 400 nm. In this method instead of measuring erythema or skin reddening , a time required to produce persistence darkening or tan on skin is measured.
You will get all pharma regulatory affairs pharmaceutical  validation guidelines, pharma process validation, cleaning validation, clinical trail regulatory guide here on, which has turned in to the worlds most popular pharmaguideline. website or blog.

Also see

What is blow fill seal technology in sterile dosage form

Aspects of Validation of Aseptic Process and Sterilisation , Sterilization of Equipment, Containers, and Closures

What is pharmaceutical product information manual (Pharmaceutical product dossier) for registration of  pharmaceutical product to foreign countries

US FDA limits dosage of acetaminophen to 325 mg per unit dosage form,Requires boxed warning on labels

What is an Isolator in pharmaceutical manufacturing

What is a Laminar Air Flow Cabinet?

21 cfr part 11 FDA guidelines .

Media Fill Run To Ensure Sterility In Sterile Dosage Forms

What is HEPA filter?

 Jobs in Pharma company Find best Pharma sales job

No comments: