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.

  1. 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?
  2. Can I add Mild Preserved Eco to extend the shelf life? What is the recommended usage percentage? Does adding Mild Preserved Eco mean the product is no longer 100% natural? What are the components of Mild Preserved Eco?
  3. Can I add Mandarin Oil for fragrance? Is Mandarin Oil considered natural? What percentage should I use?
  4. What are the required amounts for Mild Preserved Eco and Mandarin Oil in the formula?
  5. If I make changes to the formula, such as adding Mild Preserved Eco or Mandarin Oil, do I need to re-register the product with the FDA (อย.)?
  6. Could you also provide information on other ingredients I might be using or considering, such as Allantoin, Glycerin, Sodium Polyacrylate, and Bromo-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
Allantoin
เครื่องสำอาง
Glycerin (USP/Food Grade)
Glycerin (USP/Food Grade)
เครื่องสำอาง
Mild Preserved Eco™ (Preservative-Free)
Mild Preserved Eco™ (Preservative-Free)
เครื่องสำอาง
Mandarin Freshy
Mandarin Freshy
Fragrance/Flavor