Forms FDA 2512 and 2512a: Base Formulations
Definition of a "Base Formulation"
A base formulation is a partial or complete cosmetic formulation shared by two or more cosmetic products manufactured by a private label manufacturer. Private label manufacturers may greatly facilitate the filing of cosmetic products for their clients by filing their base formulations using Forms FDA 2512 (PDF 548 KB) and 2512a (PDF 734 KB). The private label manufacturers then list a base formulation as a single ingredient when filing cosmetic product formulations for their clients.
Base formulations are used to facilitate multiple filings by private label manufacturers and will not be accepted by FDA unless accompanied by three or more cosmetic product ingredient statement submissions using them.
How to File a Base Formulation
A base formulation is prepared and filed in exactly the same manner as any other cosmetic filing except the following four items:
A. TYPE OF SUBMISSION:
Check the boxes marked "Original" and "Base" in the upper right corner on Form FDA 2512.
B. 01. NAME OF MANUFACTURER/PACKER/DISTRIBUTOR (On Label)
Enter the private label manufacturer's firm name.
C. 15. PRODUCT CATEGORY CODE
Select the Product Category Code that most closely identifies the intended purpose or function of the cosmetic product formulation that the base formulation will be used in.
D. 16. BRAND NAME OF COSMETIC PRODUCT
List in the space for Brand No. 01 the base formulation name chosen by the Private Label Manufacturer for this base formulation. You may list only one base formulation on a base formulation submission.
How to File a Base Formulation as an Ingredient in a Cosmetic Product Using Forms FDA 2512 and 2512a
Form FDA 2512
Prepare and file the Form FDA 2512 in exactly the same manner as any other cosmetic filing.
Form FDA 2512a
Because the base formulation comprises most or all of the ingredients of the finished cosmetic product being filed, it should be entered in INGRED NO. 01.
6. BASE CPIS NO.
When you are filing the first three or more cosmetic product formulations with the original base formulation, leave the BASE CPIS NO. blank since the number has yet to be assigned. Use a heavy clip or rubber band to secure the cosmetic product formulations to the base formulation.
With later cosmetic product formulations enter the 7-digit CPIS number as found on the Official Receipt that you received as acknowledgment of your base formulation filing.
7. BASE NAME
Enter the base formulation name as filed.
8. COMPANY NAME
Enter the name of private label manufacturer.
If there are any other ingredients that have been added to the base formulation that are unique to the product, such as color, fragrance, or flavor they should be listed starting in INGRED NO. 02.