FDA-Approved Microspheres

What makes a microsphere FDA-approved?

In order to tell whether the microsphere can be used in cosmetics, food, or medical devices it is important to look at the raw materials that are incorporated into the microsphere during manufacturing process.  For example, unpigmented or clear polyethylene microspheres supplied by Cospheric in sizes from 10 micron to 1000 micron meet the quality requirements of the US FDA as specified in 21 CFR 172.888 and 21 CFR 178.3720.  Specific grade of polyethylene used in manufacturing of these microspheres is  FDA-approved for food applications in chewing gum base, on cheese and raw fruits and vegetables, and as a defoamer in food.

Color additives are subject to a strict system of approval under U.S. law (FD&C Act), sec. 721; 21 U.S.C. 379e. Color additive violations are a common reason for detaining imported cosmetic products offered for entry into this country. If a product contains a color additive, by law [FD&C Act, Sec. 721; 21 U.S.C. 379e; 21 CFR Parts 70 and 80] you must adhere to requirements for:

• Approval. All color additives used in cosmetics (or any other FDA-regulated product) must be approved by FDA. There must be a regulation specifically addressing a substance’s use as a color additive, specifications, and restrictions.
• Certification. In addition to approval, a number of color additives must be batch certified by FDA if they are to be used in cosmetics (or any other FDA-regulated product) marketed in the U.S.
• Identity and specifications. All color additives must meet the requirements for identity and specifications stated in the Code of Federal Regulations (CFR).
• Use and restrictions. Color additives may be used only for the intended uses stated in the regulations that pertain to them. The regulations also specify other restrictions for certain colors, such as the maximum permissible concentration in the finished product.

Continue reading “FDA-Approved Microspheres” »

Silica Microspheres – 6 micron mean Diameter

Properties

Silica is a chemically stable inorganic synthetic material.   It has the benefit of providing no irritation to human skin.  Silica is essentially transparent, colorless and promote a high degree of slip in products.  The skin feel is generally lubricious in nature.   Spherical silica imparts exceptional lubricity to loose and pressed powder products. The effect is increased ‘play time’ and a luxurious feel.  Spherical products with mean particle size between 3 to 10 micron will scatter light on the surface of its particle, ie which are transparent, but give natural coverage.

• Properties :
  - Hollow and porous spherical powder
  - Uniform size distribution
  - Excellent dispersibility
  - Good oil absorbancy
  - Good fluidity
• Applications :
  - Emulsion products
  - Makeup products
  - Anticaking agent
  - Additive carrier and perfume carrier
• Available with Optional Silicone Coating (Dimethylpolysiloxane)
  - Increases Hydrophobicity
  - Transparent
  - Resistant to acid, alkalis, UV and moisture

Silica Microspheres are available for purchase at Cospheric in R&D quantities or bulk.

Solid Red Polyethylene Microspheres Announced

Santa Barbara, CA -  May 28, 2010 - Cospheric LLC is now offering a product line of solid red polyethylene microspheres in particle size ranges from 10um to 1000um (1mm).

Offering a bright red color.  These microspheres can be used as additives in personal care products, or in fluid flow visualization experiments.  Samples are in stock and ready to ship to customers for R&D use of product evaluation.  These high quality microspheres are specified to be greater than 90% spherical, and greater than 90% in the specified size range.

Sample Density is 0.98g/cc (Custom densities are available)

Spherical Particle sizes include:

10-27um, 27-32um (30 micron), 32-38um (35 micron), 38-45um (40 micron), 45-53um (50 micron), 53-63um (60 micron), 63-75um (70 micron), 75-90um (80 micron), 90-106um (0.1mm), 106-125um, 125-150um, 150-180um, 180-212um (0.2mm), 212-250um (0.25mm), 250-300um (0.3mm), 300-355um (0.35mm), 355-400um (0.4mm), 400-500um (0.5mm), 500-600um (0.6mm), 600-710um (0.7mm), 710-850um (0.8mm), 850-1000um (0.9mm).

Solid Polyethylene Microspheres for Effects in Color Cosmetics

A recent article in Cosmetics & Toiletries magazine describes the use Solid Polyethylene Mirospheres for Effects in Color Cosmetics.

Flesh Tone Microspheres - Color Matched to Skin Sample

Micropsheres have been used in cosmetics for some time, primarily as fillers and exfoliators. Most recently scientists started to utilize light reflecting properties of microspheres for creating unique optical effects, such as optical blurring and wrinkle filling.  Due to light scattering effects of the spherical surface, formulating with appropriate microspheres can minimize the appearance of fine lines and uneven skin tone, due to optically reducing contrast on the skin.

The spherical shape and smooth surface of microspheres creates a low friction ball-bearing effect that gives formulations an elegant, silky feel. This ball-bearing effect promotes better blending on the skin and a more natural finish due to the enhanced slip, glide and omnidirectional spreadability, imparting a cream to powder texture. Outstanding roundness also provides lubrication during application, which enhances the tactile experience of a cosmetic product. Continue reading “Solid Polyethylene Microspheres for Effects in Color Cosmetics” »

What is a Microsphere?

Definition From Wikipedia,

Microsphere is a term used for small spherical particles, with diameters in the micrometer range (typically 1μm to 1000μm (1mm)). Microspheres are sometimes referred to as microparticles.

Microspheres can be manufactured from various natural and synthetic materials. Glass microspheres, polymer microspheres and ceramic microspheres are commercially available. Solid and hollow microspheres vary a lot in density and, therefore, are used for different applications. Hollow microspheres are typically used as additives to lower the density of a material. Solid microspheres have numerous applications depending on what material they are constructed of and what size they are. Continue reading “What is a Microsphere?” »