• An identity statement, indicating the nature and use of the product, by means of either the common or usual name, a descriptive name, a fanciful name understood by the public, or an illustration [21 CFR 701.11].
• An accurate statement of the net quantity of contents, in terms of weight, measure, numerical count or a combination of numerical count and weight or measure [21 CFR 701.13].
The following information must appear on an information panel:
• Name and place of business. This may be the manufacturer, packer, or distributor. [21 CFR 701.12].
• Distributor statement. If the name and address are not those of the manufacturer, the label must say “Manufactured for…” or “Distributed by…” [21 CFR 701.12].
• Material facts. Failure to reveal material facts is one form of misleading labeling and therefore makes a product misbranded [21 CFR 1.21]. An example is directions for safe use, if a product could be unsafe if used incorrectly.
• Warning and caution statements. These must be prominent and conspicuous. The FD&C Act and related regulations specify warning and caution statements related to specific products [21 CFR part 700]. In addition, cosmetics that may be hazardous to consumers must bear appropriate label warnings [21 CFR 740.1]. An example of such hazardous products is flammable cosmetics.
• Ingredients. If the product is sold on a retail basis to consumers, even it it is labeled “For professional use only” or words to that effect, the ingredients must appear on an information panel, in descending order of predominance. [21 CFR 701.3]. Remember, if the product is also a drug, its labeling must comply with the regulations for both OTC drug and cosmetic ingredient labeling, as stated above.
Ah, Trish! I am so sorry. You were outside selling during this, right?
How did your product fare?
Looking on the positive side, I would rather blazing sun than pounding rain. =) Sell lots today!
Great ideas here! If I had been thinking a little more ahead, I should have included a little after sun care items in my display this weekend at Harvest Days (Battleground, WA.) It was close to 90 degrees yesterday and the sun was blazing! Now, I'm going back today and will find all kinds of pink-shaded people wandering up to my booth (and me caught with my pants down and nothing to offer for sunburn relief!) 🙂
Great tips on the labeling. the reminders are always helpful.
Yes, I'd just up each of those oils by the amount you're taking away of the German Chamomile. So, 15 drops extra of each ….
Would you increase the amount of lavender and Egyptian Geranium to make up for the "loss"?
Having never really had the chance to play with EO's (other than blending peppermint and spearmint for migraine treatment) I've got lots of questions. (sorry!)
Roman and German Chamomile are pretty different because it's the azulene content that helps with the skin redness.
So, in this case, I'd actually use Lavender EO and Egyptian Geranium and skip the Roman Chamomile because the Roman Chamomile is a different species and is typically used as an antibacterial, antifungal and calming essential oil.
Lavender EO is awesome on burns so it'll still be good =)
Quick question… while I *know* the German Blue chamomile has the best healing properties, will other chamomiles work? Budget won't allow for the "good stuff". 🙁
Yay! Perfect timing on this. 🙂
Good catch! I'll put that info in right now!
How much infused oil for those EO measurements? I don't see weight or volume. 🙁
Thank you for continued reminders about labeling requirements. VERY important.
Thanks for the label information… strangely I was on the FDA site this morning reading up on it. Your version is seems more concise and straight to the point! 🙂