Adjusting Texture of FDA-Approved Formulations
Question
I have two manufactured formulations:
- Anti-oxidant & Hydrating Essence: This formula feels very sticky/tacky on the skin after application, like syrup. The skin feels like it's 'absorbing' everything it touches and remains tacky until washed off.
- Skin Rejuvenation Serum: This formula is not sticky but feels slightly tacky on the skin.
I would like advice on purchasing ingredients to adjust the formulas myself, as they have already received FDA approval and cannot be officially modified.
- If I purchase WaterSoft (PEG/PPG-17/6 Copolymer) and add it to these formulas, will it help reduce the stickiness/tackiness when applied to the skin? Are there any other ingredients that can help reduce stickiness/tackiness?
- If I can add it, what percentage should I use? Can I mix it directly in the bottle by shaking? Will adding this ingredient have any negative impact on the formula?
Answer
Subject: Advice on adjusting manufactured formulations
Thank you for reaching out regarding the texture of your two manufactured formulations, Anti-oxidant & Hydrating Essence and Skin Rejuvenation Serum. You mentioned that the Anti-oxidant & Hydrating Essence feels very sticky/tacky, like syrup, and the Skin Rejuvenation Serum feels slightly tacky.
You are asking for advice on adding ingredients yourself to adjust the texture, specifically mentioning WaterSoft (PEG/PPG-17/6 Copolymer), because the formulas have already received FDA approval and cannot be officially changed.
It is strongly advised against adding any ingredients to a finished cosmetic product that has already been manufactured and received FDA approval. Here's why:
- Stability: Adding ingredients can disrupt the stability of the original formulation, potentially causing separation, changes in texture, color, or odor over time.
- Preservation: The preservative system in the original formula is designed to protect that specific combination of ingredients. Adding new ingredients can overload the preservative system or introduce contaminants, leading to microbial growth and potential safety issues.
- Efficacy and Safety: The efficacy and safety testing for the product were based on the original formula. Adding ingredients can alter the intended effects and could potentially cause irritation or other adverse reactions.
- Regulatory Compliance: Modifying an FDA-approved product by adding ingredients yourself invalidates the original approval and means the modified product has not gone through the necessary regulatory process.
Regarding your question about WaterSoft (PEG/PPG-17/6 Copolymer): This ingredient is often used in cosmetic formulations to improve skin feel and reduce tackiness, acting as a humectant and conditioning agent. In principle, adding a small amount might help with the texture. However, for the reasons mentioned above, adding it to a finished product is risky and not recommended.
Determining the correct percentage of WaterSoft (or any other ingredient) and the proper method for incorporating it to achieve the desired texture without compromising stability, safety, and efficacy requires proper formulation development and testing in a laboratory setting before manufacturing. It is not something that can be reliably done by simply adding and shaking in the final product bottle.
Recommendation for Future Batches:
If you plan to manufacture future batches of these products, the recommended approach is to work with your manufacturer to adjust the original formula before production and resubmit the modified formula for FDA approval. This allows for proper testing and ensures the final product is stable, safe, effective, and compliant with regulations.
For the current batches you have, it is best to use them as they are or explore alternative application methods (e.g., using a smaller amount) rather than attempting to modify them yourself.