# Label Requirements



## Timberline

Question for those of you who make and sell items that go with soaps, like lotions and lip balms. Do you have all the required things (ingredients in descending order, warning statement, safe usage directions etc) on your labels? I'm trying to figure out how to add the warning label so it meets the requirements for font size and placement, without distracting from my product or worse, scaring off customers. Any ideas? 
Regulations on this site:

http://www.cfsan.fda.gov/~dms/cos-toc.html

Also, according to what I read here, if you list vitamins (like Vit E), then you are risking having your product classified as a drug. I can't imagine what a nightmare that would be.

I make just simple lip balms and hand creams, no actual lotions (with with water and ewax, preservatives, etc.). but they are still classified as cosmetics. I have always made these things just for my own use, but have been invited to bring them into a year round farmer's market and don't want to do anything wrong. I also make and sell soaps, but they are exempt from the cosmetics regulations unless you claim they alter skin appearance, etc. 

I appreciate any experiences/advice.
Thanks.


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## Jen H

Yep, my labels comply with the FDA regulations. Fitting everything in is a huge challenge, and getting the contact info on the label is another challenge on it's own. 

It's a real pain, especially with the lip balm labels.

My understanding is that it's only classified as an over-the-counter drug if you attribute any health claims to it. For example, if you say "heals chapped skin", that's a medical claim and bumps it into over the counter drug territory. If you just say "hand balm", you're not making any claims and are ok. You still have to list all the ingredients, but you don't have to worry about the drug regulations.

As such, I don't sell "excema balm" or "sore muscle salve", I just sell salves and balms and point people to the appropriate one when they tell me what they're needs are. I just say "here, you might try this one." My lotion just says "lotion".

I do know an herbalist (her arnica balm is just amazing) who does sell "sore nipple salve" and "sore muscle salve" and "immunity boost tincture". Her philosophy is different than mine, and she feels that "sore muscle salve" is just the name of the product and not a medical claim.

At the end of the day, you have to decide what it is you're comfortable with doing, and what your customers are looking for.


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## Timberline

Thanks, Jen. How is your warning label worded? Trying to figure out how I'm going to get all of this on a lip balm tube label and still have it look nice.


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## Jen H

Mine says "The FDA has not evaluated the safety of this product." in a 5-point font. I can't remember the font name right now, it's on my home computer. The warning is on the front of the label, below my stated net weight. That warning hasn't hurt my sales at all.

My lip balm labels go from the twisty part at the bottom all the way up to where the cap snaps on, and they wrap all the way around. That's the only way I had enough room to list ingredients, place of manufacture, and the name of the product. As it is, I'm experimenting right now with cutting down on the number of oils I use so I can get the ingredient list pared down and use a bit more user friendly font size.

Labels are a pain in the tuckus, no doubt about it! I play with them only because I have to -- it's my least favorite part of making product and selling it.


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## Timberline

Thanks again, one more question for you. Do you have some sort of statement like "If irritation occurs discontinue use" for liability purposes?


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## kidsngarden

My labels meet FDA with INCI names on them etc. And yes, I do have a discontinue use if irritation occurs. I also have a suggestion that they use my lotion within three months of purchase. Even though it has been tested for the preservative doing its job and passed, I still want to cover my butt.

Bethany


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## Vicki McGaugh TX Nubians

To actually be ligit, each and every batch you make would have to be tested also. Yes I label correctly and have my recipe, not each batch, tested...for my stores. No I do not for my customers or those who buy off my website or resell my products, they want the common names on them. Thankfully the only label police around, ever, are other soapmakers  Vicki


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## kidsngarden

Vicki McGaugh TX Nubians said:


> To actually be ligit, each and every batch you make would have to be tested also. Yes I label correctly and have my recipe, not each batch, tested...for my stores. No I do not for my customers or those who buy off my website or resell my products, they want the common names on them. Thankfully the only label police around, ever, are other soapmakers  Vicki


Yeah, I know they all would have to be tested, but who in small business can do that? I think it's pretty good I tested it ONCE since a lot of people don't even do that.

Bethany


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