Drug Manufacturing License Application Form - California

State of California—Health and Human Services Agency California Department of Public Health

Food and Drug Branch

CDPH 8678 (02/11)

Fund 0082 Index 5623 PCA 76202 Receipt Source 125700 Agency Source 0044

Page 1 of 2

COSMETIC MANUFACTURING REGISTRATION APPLICATION

PLEASE COMPLETE THIS FORM FULLY—INCOMPLETE APPLICATIONS WILL BE RETURNED

See Page 2 for Instructions

NEW APPLICANT

RELOCATION

OWNERSHIP CHANGE

OWNERSHIP AND LOCATION CHANGE

RENEWAL

1. Legal Name of Firm

9. Facility Operator (name and title)

2. DBA (List additional DBAs on separate sheet if necessary.) 10. Facility Telephone Number

( )

11. Facility FAX Number

( )

3. Facility Address (number, street) 12. 24-Hour Emergency Telephone Number

( )

13. E-Mail Address

4. Facility Address (continued) 14. Correspondent (name and title)

5. City State ZIP Code 15. Correspondent Telephone Number

( )

16. Correspondent FAX Number

( )

6. Mailing Address (if different or P.O. Box number) 17. County 18. Country (if other than United States)

7. Mailing Address (continued) 19. Web Site (URL)

8. City State ZIP Code

20. Type of Ownership: Individual/Sole Proprietorship Partnership Corporation/Limited Liability Company Nonprofit Other:

(attach copy of Partnership agreement or Articles of Incorporation)

21. Corporate Name (if applicable) State of Incorporation

22. Owners’ or Officers’ Names and Titles Owners’ or Officers’ Names and Titles (Attach separate sheet if necessary)

23. Size of Facility (square feet):________________

Business days and hours:____________________

Number of Employees at this Facility:____________________

Business License Number:_____________ Seller’s Permit:________________

Fictitious Business Name (FBN) Yes No

(attach copy of business license, Seller’s Permit and FBN)

25. Products manufactured at this location (check all that apply): (If denoted with an asterisk, submit a list of ingredients and labeling exemplars for each product.)

Acne products*

Hair care i.e., shampoo, conditioner, coloring agents, relaxers

Antiperspirants* Lubricants, i.e., personal, sexual, massage oil*

Bath products, i.e., salts, oils

Oral products, i.e. mouthwash, toothpaste*

Color cosmetic, i.e., eye brow pencils, eyeliner, lipsticks Perfumes/colognes

Halloween makeup

Skin bleaching, i.e., skin lighteners, age-spot removers*

Deodorants, i.e., underarm, vaginal Shaving creams

Depilatories

Sunscreen, i.e., any products claiming SPF*

Eye area products, i.e., products designed exclusively for Topical dry skin care i.e., pressed powder, talc dusting powder

sensitive eye area Topical liquid skin care, i.e., moisturizer, toner, astringent

Facial mask Wrinkle cream

Fingernail preparations, i.e., polish, remover, artificial nails Other (specify):__________________________________

* ALL APPLICANTS: In order to receive a Cosmetic Manufacturing Registration from this Department, if you manufacture ACNE PRODUCTS, ANTIPERSPIRANTS, LUBRICANTS,

ORAL PRODUCTS, SKIN BLEACHING PRODUCTS or SUNCREENS, you must submit a list of ingredients and labeling exemplars for each product manufactured along with this

application form, as you may be required to obtain a Drug Manufacturing License for these products.

NEW APPLICANTS: In order to receive a Cosmetic Manufacturing Registration from the Department you must submit a copy of the Secretary of State Corporation Name form and

Fictitious Name statement (if applicable) with the Cosmetic Manufacturing Registration Application form.

Registration Fee: $507

(Fee is Non-Refundable)

MAKE CHECKS PAYABLE TO: CA DEPARTMENT OF PUBLIC HEALTH

See page 2 for mailing address

The Food & Drug Branch MUST BE NOTIFIED IMMEDIATELY of any change in the application information per the CA Health & Safety Code, §111805.

By signature, I declare under penalty of perjury that all information provided herein is true and correct.

26. Signature

Printed Name

Title

Date

PLEASE DO NOT WRITE BELOW THIS LINE.