Sunscreen Lotion with SPF 100?????

Formulating

Sunscreen Lotion with SPF 100?????

Posted by paoloferino on July 1, 2019 at 7:29 am

Good day!

I’m eyeing to develop a lotion SPF100, do you have any recommendation on what active RM’s should I use. Is there any manual computation to verify the SPF in the formula? BTW, is SPF100 feasible?

MarkBroussard replied 5 years, 4 months ago 5 Members · 12 Replies
12 Replies

MarkBroussard

Member
July 1, 2019 at 11:27 am

@paoloferino

https://www.sunscreensimulator.basf.com/Sunscreen_Simulator/login

Load up all of the appropriate sunscreen actives at the maximum percentage allowed by the FDA. Neutrogena markets a 100 SPF-rated sunscreen so you can check its LOI
paoloferino

Member
July 2, 2019 at 1:18 am

MarkBroussard said:

@paoloferino

https://www.sunscreensimulator.basf.com/Sunscreen_Simulator/login

Load up all of the appropriate sunscreen actives at the maximum percentage allowed by the FDA. Neutrogena markets a 100 SPF-rated sunscreen so you can check its LOI

@MarkBroussard Thank you for your response, This will be very useful in my project. Again, many thanks!
paoloferino

Member
July 2, 2019 at 1:27 am

@MarkBroussard

Hello. Already opened the link you’ve sent to me. Where do I input the ingredients? I can’t find it the page.

Thank you for your response.
Microformulation

Member
July 2, 2019 at 1:46 am

,"y","w":492,"h":95,"abs_x":384,"abs_y":1650}”>Uf you look at the new proposed monograph in the US, it is advocating SPF 60+ as the highest and requiring a New Drug Application for 80+. There is a great article in HAPPI. https://www.happi.com/issues/2019-04-01/view_sunscreen-filter/fda-proposal-part-i-is-the-wait-finally-over/
paoloferino

Member
July 2, 2019 at 3:08 am

Microformulation said:

,"y","w":492,"h":95,"abs_x":384,"abs_y":1650}”>Uf you look at the new proposed monograph in the US, it is advocating SPF 60+ as the highest and requiring a New Drug Application for 80+. There is a great article in HAPPI. https://www.happi.com/issues/2019-04-01/view_sunscreen-filter/fda-proposal-part-i-is-the-wait-finally-over/

Thank you for the information. Is this already being implemented since it was only a proposal? Just to be clear, the SPF 60++ should be the highest SPF claim for a cosmetic product? If the SPF is raised up to 80, it will be a drug application?
OldPerry

Member
July 2, 2019 at 3:38 am

All sunscreen products in the US are drug products.
paoloferino

Member
July 2, 2019 at 4:08 am

Perry said:

All sunscreen products in the US are drug products.

Thank you Sir Perry. So if US FDA implements that all sunscreen products are drug products, I assume the ASEAN community also follows the provision when incomes to sunscreen products? We only have a license to operate as a Cosmetic Manufacturer meaning we need to apply for a Drug manufacturer.

Many Thanks!
Microformulation

Member
July 2, 2019 at 12:46 pm

It is not yet fully approved, but if you read the full report and their reasons behind the standards, you will see that it is based on some good Science. Also, and I have been in this situation, you don’t want to position yourself in the market with a product which may later be disallowed. Or do you? It does create a lot of fast reformulation, which keeps Chemists busy. Good for the Formulator, not so much for the product line though.

As Perry pointed out, in the US all sunscreens are Over the Counter Drug products. The New Drug Application referenced in the article would be a request to the FDA to go higher in SPF.

What is your “added value” for going above SPF 60?
Sponge

Member
July 2, 2019 at 3:06 pm

@Microformulation re: limited UVA protection mentioned in the article. That’s really interesting. In all the reading I’ve done about sunscreen, this has never been presented as a potential problem. I never really thought about it until now.
MarkBroussard

Member
July 2, 2019 at 7:09 pm

@sponge:

UVA protection is a much bigger problem than UVB protection from a skin damage perspective which is why it’s now a focal point of the FDA.
paoloferino

Member
July 3, 2019 at 1:32 am

Microformulation said:

It is not yet fully approved, but if you read the full report and their reasons behind the standards, you will see that it is based on some good Science. Also, and I have been in this situation, you don’t want to position yourself in the market with a product which may later be disallowed. Or do you? It does create a lot of fast reformulation, which keeps Chemists busy. Good for the Formulator, not so much for the product line though.

As Perry pointed out, in the US all sunscreens are Over the Counter Drug products. The New Drug Application referenced in the article would be a request to the FDA to go higher in SPF.

What is your “added value” for going above SPF 60?

Thank you for your information. I just added moisturizers and anti-irritants in the formulation. As per Sir Perry, all sunscreen products are products. Does it mean that regardless of the SPF 15 or 100, it is considered as Drug?

I just need the information so that I can raise it to the management I’m working in.

Many thanks!
MarkBroussard

Member
July 3, 2019 at 2:22 am

@paoloferino:

In the US, all sunscreen products are regulated as OTC drug products. So, at present, regardless of whether it is SPF 15 or SPF 80, both are regulated the same.

Per the proposed new monograph, all sunscreens SPF 80 and below would be regulated as OTC drug products. But, sunscreens SPF 80+ would be regulated as drugs and would require a New Drug Application.

Keep in mind that Hawaii and other jurisdictions have recently passed bans on Oxybenzone and Octinoxate as sunscreen ingredients, so you will not want to include those in any new sunscreen formula.

Given that it is highly likely that the new monograph will go into effect, you might want to target something in the SPF 60 to 80 range as opposed to going up to SPF 100.