Which Dimethicone is OTC skin protector

AbdullahAbdullah Member
Is dimethicone 5cst at %1-2 an OTC Skin protectant active ingredient? 

If not then which dimethicone is? 

Comments

  • PharmaPharma Member, Pharmacist
    In Europe, dimethicone is not an active ingredient but an excipient.
  • AbdullahAbdullah Member
    @Pharma how about us?

  • MicroformulationMicroformulation Member, Professional Chemist
    I don't recall, but when we needed to know we accessed an old patent. *Scar Products" I 'believe" it was the 200 cst or higher.
    markfuller@microformulation.com Microformulation.com Microformulation Cosmetic Consulting provides Custom Formulations for both large Commercial accounts as well as smaller entrepreneurs. We can provide Naturally compliant Formulations under the NSF, NPA, Whole Foods and USDA Organic Certifications. BS.Pharm Albany College of Pharmacy, Union University.
  • AbdullahAbdullah Member
    edited June 4
    @EVchem @Microformulation thanks 

    In this list Colloidal oatmeal, 0.007 percent minimum; 0.003 percent minimum in combination with mineral oil is a skin protectant. Is it really that effective at such small quantity? 
  • PerryPerry Administrator, Professional Chemist
    @Abdullah - I suspect the colloidal oatmeal makes no difference 

  • AbdullahAbdullah Member
    @Perry thanks 

    So why would they list it as skin protectant in such small quantity? 
  • PerryPerry Administrator, Professional Chemist
    @Abdullah - It's likely that someone, somewhere had a study that demonstrated an effect in combination with mineral oil. But I would say that is probably just an anomaly and it probably doesn't have a real impact. Just my opinion though. 

  • AbdullahAbdullah Member
    @Perry thanks. 

  • PhilGeisPhilGeis Member, Professional formulator
    From OTC Skin Protectant Monograph (https://www.govinfo.gov/content/pkg/FR-2003-06-04/pdf/03-13751.pdf)
    (f) Colloidal oatmeal, 0.007 percent minimum; 0.003 percent minimum in combination with mineral oil in accordance with § 347.20(a)(4).
    (g) Dimethicone, 1 to 30 percent
    (l) Mineral oil, 50 to 100 percent; 30 to 35 percent in combination with colloidal oatmeal in accordance with § 347.20(a)(4).
  • PerryPerry Administrator, Professional Chemist
    @PhilGeis - I saw that. I just am skeptical that even though there was enough evidence to convince regulators to include colloidal oatmeal at those low levels in the monograph, I doubt it provides any noticeable benefit over just using mineral oil alone. I'm sure they have a study that demonstrates an effect. I just remain skeptical and without replication see it as a statistical anomaly. 

  • PhilGeisPhilGeis Member, Professional formulator
    Me too Perry.   Here's what they say about % - 

     The agency has reviewed the recommended concentrations of colloidal oatmeal reported in the literature and reference texts (Refs. 4, 29 through 32, 34 through 45, 47, 48, and 49) and has considered the range ofoncentrations for colloidal oatmeal used in bath additive products and in other dosage forms. Products containing colloidal oatmeal have been formulated in the following dosage forms: Lotion (1 and 10 percent colloidal oatmeal), cleansing cream (8 percent colloidal oatmeal), shampoo (5 percent colloidal oatmeal), and cleansing bars (30, 50, and 51 percent colloidal oatmeal) (Refs. 4, 46, and 47). The agency has calculated the approximate minimum and maximum concentrations of colloidal oatmeal that have been used as follows: For regular colloidal oatmeal, a range of 0.023 to 0.625 percent when used as a tub bath soak (Refs. 29, 34 through 38, and 44), a range of 0.24 to 1.2 percent when used as a foot bath soak (Refs. 30, 31, and 34), a range of 0.24 to 15 percent in aqueous solution when used in a wet pack (Refs. 30, 31, 32, 34, and 45), and a range of 3.75 to 15 percent in aqueous solution when used as a topical lotion (Refs. 30, 32, and 34); for oilated colloidal oatmeal, a range of 0.003 to 0.03 percent when used as a tub bath soak (Refs. 35 and 39 through 43).
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