1. Mica and Color

2. What we will learn What is mica? How is mica regulated?
What does approved use mean?
How to properly label for cosmetics and soap.

3. Types of Mica
Two kinds of mica
Naturally mined
Synthetic mica

4. Mined Muscovite Mica

5. Muscovite Mica Sheet

6. Synthetic Mica and Natural Mica

7. Colored Mica Powder Mica sheets are ground into a fine powder
Oxides and other pigments are added to mica
Pigments are layered on the powder and heat is applied to achieve varying metallic effects

8. Colored Mica Powder

9. Mica is a composite pigment
How is mica regulated?
Mica is a composite pigment
Mica + Color = Mica-based pearlescent pigment
Natural mica and synthetic mica are regulated differently

10. Color additives used in combination to achieve variable effects.
Composite Pigments
Color additives used in combination to achieve variable effects.
Are subject to the same regulations as all other color additives.

11. SIZE MATTERS!
For Mica based pigments, the FDA limits the particle size for eyes to maximum 150 microns.
Mica shall conform to the following specifications…Fineness, 100 percent shall pass through a 100-mesh sieve.

12. Synthetic Mica
Also known as Fluorphlogopite
Larger range of particle sizes - Micron size not regulated by the FDA
Color additive regulations must still be followed!

13. Color Additive Regulations
Exempt from certification
Do not need to be sent to the FDA before resale
Subject to certification
Need to be sent to the FDA for certification before resale

14. Some are subject to limitations
Approved Use
Three approval categories
Eyes
Lips
External Use
Some are subject to limitations

15. Name
Eyes
Lips
External Use
Limitations

16. External Use
The terms externally applied drugs and externally applied cosmetics mean drugs or cosmetics applied only to external parts of the body and not to the lips or any body surface covered by mucous membrane.

17. Subject to Limitations
A color additive permitted for use on eyes, lips, or external use with limits on use.
Example: D&C Red No. 33
Approved for Lips: Lipstick  products ≤3%; mouthwash, dentrifices

18. An approved color additive must be safe for lips!
Bath Bombs
An approved color additive must be safe for lips!
NO chromium oxide green, ultramarine blue, or D&C Red 33!
NO soap stable green or blue micas!

19. What is True Soap?
True soap is not regulated by the FDA and color additive regulations do not apply.

20. What ingredients cause its cleaning action:
To be regulated as “soap,” the product must be composed mainly of the “alkali salts of fatty acids,” that is, the material you get when you combine fats or oils with an alkali, such as lye.

21. What it’s made of:
To be regulated as “soap,” those “alkali salts of fatty acids” must be the only material that results in the product’s cleaning action. If the product contains synthetic detergents, it’s a cosmetic, not a soap.

22. How it's intended to be used:
To be regulated as soap, it must be labeled and marketed only for use as soap.
No cosmetic or drug claims!

23. Order of Ingredient Declaration Descending order of predominance
Grab your worksheets!
Order of Ingredient Declaration
Descending order of predominance
UNLESS…

24. Exceptions…
Color additives of any concentration may be listed in any order after the listing of the ingredients which are not color additives.
Color additives

25. Ingredients with less than 1% concentration
Exceptions…
Ingredients present at a concentration not exceeding 1% may be listed in any order after the listing of the ingredients present at more than 1% in descending order of predominance.
Ingredients with less than 1% concentration

26. Example 1 of the worksheet
We Can Label Two Ways
Labeled two ways
Both are correct!
Example 1 of the worksheet

27. Mica, titanium dioxide, chromium oxide green
The Tale of Two Micas:
Mica, titanium dioxide, chromium oxide green
Green Vibrance Mica

28. Mica, titanium dioxide, iron oxide, manganese violet
The Tale of Two Micas:
Mica, titanium dioxide, iron oxide, manganese violet
Pink Vibrance Mica

29. Can they be used in: Lipstick? Eye Shadow? Soap? Body Butters?
Bath Bombs?
Body Butters?
Soap?
Eye Shadow?
Lipstick?

30. Cold Process Soap
You are making a cold process soap with the above micas with no cosmetic claims such as moisturizing. What color additive label requirements do you need to follow?

31. Melt and Pour Soap
Sorbitol, Propylene Glycol, Sodium Laureth Sulfate, Sodium Stearate, Sodium Laurate, Glycerin, Water + Green Vibrance + Pink Vibrance. What should your label look like?

32. Melt and Pour Soap (2)
Safflower Oil, Glycerin, Purified Water, Sodium Hydroxide, Sorbitol, Propylene Glycol, Sorbitan oleate, Oat protein + Green Vibrance + Pink Vibrance. What should your label look like?

33. The end!
Any questions?