Lotion Formulation: Natural/Organic Claims, Preservation, and FDA Registration
ถามโดย: kanjanapa.petra
เมื่อ: February 28, 2018
ประเภทผลิตภัณฑ์:
เครื่องสำอาง
คำถาม
I am formulating a lotion and have some questions about ingredients, claims, and registration.
- Regarding the claim "Organic": What is the difference between "Organic" and "Natural"? Can my formula be claimed as "Certified Organic" or "Natural" using ingredients like Goat Milk Powder and Mandarin Oil? If I add other ingredients, does it affect the "Natural 100%" claim?
- Can I add
Mild Preserved Ecoto extend the shelf life? What is the recommended usage percentage? Does addingMild Preserved Ecomean the product is no longer 100% natural? What are the components ofMild Preserved Eco? - Can I add
Mandarin Oilfor fragrance? IsMandarin Oilconsidered natural? What percentage should I use? - What are the required amounts for
Mild Preserved EcoandMandarin Oilin the formula? - If I make changes to the formula, such as adding
Mild Preserved EcoorMandarin Oil, do I need to re-register the product with the FDA (อย.)? - Could you also provide information on other ingredients I might be using or considering, such as
Allantoin,Glycerin,Sodium Polyacrylate, andBromo-5-nitro-1, 3-dioxane?
คำตอบ
Lotion Formulation Questions
Based on your questions and the staff's response:
"Organic" vs "Natural" Claims
- The ingredients you mentioned, such as Goat Milk Powder and Mandarin Oil, are considered natural but are not typically certified organic.
- Therefore, your product cannot be claimed as "certified organic."
- If you are aiming for a "natural" product, adding ingredients that are not natural will prevent you from claiming "100% natural."
Adding Mild Preserved Eco™
- Yes, you can add Mild Preserved Eco™ to help extend the shelf life of your lotion.
- However, Mild Preserved Eco™ is not a natural ingredient. Adding it means your product will no longer be 100% natural. You might be able to claim a high percentage of natural ingredients (e.g., 99%).
- Mild Preserved Eco™ is a blend of Ethylhexylglycerin and 1,3 Propanediol. It is not classified as a preservative by the FDA, allowing products using it for preservation to claim "preservative-free."
- The recommended usage rate for Mild Preserved Eco™ in general cosmetic formulas to prevent spoilage is 0.5-2.0%. It should be added in the final step of the formulation.
Adding Mandarin Oil
- Yes, you can add Mandarin Oil (such as Mandarin Freshy) for fragrance.
- Mandarin Oil is considered a natural ingredient (though not necessarily certified organic).
- The amount to use depends on the desired scent intensity. You should follow guidelines for fragrance oil usage rates in lotions, which can vary.
Required Amounts
- For Mild Preserved Eco™, the recommended usage rate is 0.5-2.0%.
- For Mandarin Oil, the amount needed for fragrance will depend on the specific oil and your desired scent strength. There is no single "required" amount; you would add it to achieve the desired fragrance level, following safe usage guidelines for essential or fragrance oils in skincare.
FDA (อย.) Registration
- Yes, according to the staff's response, any changes to your formula, such as adding Mild Preserved Eco™ or adding/changing a fragrance (unless it's just swapping one fragrance blend for another under the same declared ingredient name like 'Fragrance'), require re-registration with the FDA (อย.).
Other Ingredients Mentioned
You also listed other ingredients:
- Allantoin: This is a common cosmetic ingredient known for reducing irritation and promoting skin tissue formation. It can be naturally derived.
- Glycerin: This is a humectant that helps retain moisture. It is widely used in cosmetics and can be natural-derived (USP/Food Grade).
- Sodium Polyacrylate: This is a synthetic polymer often used as a thickener or stabilizer in cosmetic formulas. It is not a natural ingredient.
- Bromo-5-nitro-1, 3-dioxane: This is a synthetic formaldehyde-releasing preservative. Given your goal for a natural product, this ingredient would not align with that aim.
In summary, while you can add Mild Preserved Eco™ and Mandarin Oil to your lotion, adding Mild Preserved Eco™ will mean the product is no longer 100% natural. Any formula changes will require re-registration with the FDA.
I hope this helps with your formulation!
ผลิตภัณฑ์ที่เกี่ยวข้องที่กล่าวถึง
Allantoin
เครื่องสำอาง
Glycerin (USP/Food Grade)
เครื่องสำอาง
Mild Preserved Eco™ (Preservative-Free)
เครื่องสำอาง
Mandarin Freshy
Fragrance/Flavor