Article by: Perry Romanowski

On the cosmetic science forum someone posed this question, “Where can I find the monograph for cosmetics?” It’s an interesting question for a number of reasons so I thought I would make a complete blog post out of it. To answer this question, we need to step back and discuss what a monograph is.

FDA Monographs

A monograph is essentially a recipe book that tells formulators exactly the ingredients, doses, and formulations they can use when creating an over-the-counter drug. It also gives the exact claims that can be made about the product and describes other labeling requirements.

This means that the technical answer to the original question about finding monographs for cosmetics is “nowhere because they do not exist.” Monographs are for drugs, not for cosmetics.

Cosmetic monographs

While that answer is technically correct it is also incomplete because there are a number of cosmetic like products that are classified as over-the-counter (OTC) drugs here in the United States.

Here is a list of cosmetic/OTC products that are governed by an FDA monograph. If you are formulating one of these products, you will have to follow the rules described in the OTC monograph.

1. Anti-acne products – This monograph describes 40 different ingredients that can be used for anti-acne. Rule was finalized in 1990 although there was some action in 2010 on Benzoyl Peroxide.

2. Toothpaste & anti-cavity products – This monograph gives a list of over 20 ingredients that can be used to fight cavities. The final rule was issued in 1995.

3. Topical anti-fungal – Products that are topically applied to places that need anti-fungal effects (diaper rash, feet, etc). Final rule was originally passed in 1993.

4. Anti-microbial products – There is a long list of ingredients that can be used for topical anti-microbial products. For most of the antimicrobial ingredients, the final rule has not yet been issued. It is suggested you follow the proposed rules when formulating.

5. Antiperspirant – This monograph is for products that are designed to stop sweating. The final monograph was originally issued in 2003. It lists 26 active ingredients that you can use.

6. Astringents – These are classified as skin
protectants. The final rule was originally issued in 2003.

7. Corn & Callus removers – Definitely a niche product but some cosmetic companies might want to create these formulations.

8. Dandruff products – If you are planning to create an anti-dandruff shampoo, then you have to follow the rules of this monograph. The final monograph was issued in 1991 & revised in 1992.

9. Hair growth / hair loss – The final monograph for these types of products was issued in 1989 and includes nothing that works. However, in 1994, Minoxidil was switched from a perscription drug to an OTC. It remains the only non-perscription option.

10. Nailbiting products – There is a monograph for products that are designed to stop people from biting their nails. Who knew? The final monograph was issued in 1993.

11. Psoriasis – These products are designed to treat the condition of psoriasis. The tentative monograph was issued in 1986 and has yet to be finalized. Only a couple of active ingredients are allowed including Coal Tar and Salicylic acid.

12. Skin bleaching – Skin lightening products are OTCs in the US. The tentative final monograph was issued in 1982 but it has yet to be finalized. There are only 2 active ingredients acceptable for skin lightening.

13. Sunscreen – It’s been a long time coming but a final monograph on this topic was issued in 2011.

14. Topical analgesic – These products find a wide variety of application and cover products such as those designed for diaper rash, cold sore treatments, poison ivy treatments, and others.

15. Wart remover – Products that are used to remove warts. The final monograph was issued in 1990 but updated in 1994. Thirteen active ingredients are listed.

Monographs and the cosmetic chemist

It is crucial that you understand the monographs for any product that you are formulating. They list exactly the raw materials you can use, the amounts, and even dictate the claims you can make. And while it may be a bit restrictive from a formulating standpoint, it is useful to know exactly what ingredients have been tested and shown to be effective for some specific condition.

See the following link for a complete list of all the US FDA Monographs.

And for more questions answered about OTC drugs, see this Q&A list from the FDA.


  1. Avatar

    Hi Perry
    How to see the 40 ingredients listed on Anti-Acne category? I clicked on the link, but didn’t find any list of ingredients.

      1. Avatar

        That means if we use 0.5~2% of salicylic acid, it could become a drug?

        1. Avatar

          My mistake. Does it mean if we use 0.5~2% of salicylic acid, we can claim it as “cosmetics”, and if over 2% (up to 5%), it would be considered as a “drug” ?

      2. Avatar

        And how about Retinol ? What’s the maximum dosage can we use for a cosmetic product?

  2. Avatar

    Hey Perry, when did you first publish this post about monographs?

    1. Avatar
      Perry Romanowski

      April 2012. I haven’t gone through to make sure all the links work but they did when I wrote it. Not much has changed so the information is still accurate as far as I know. There may be a few things that changed but nothing major.

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  6. Avatar

    I have few questions regarding OTC vs cosmetics
    1) In the list of the monographs I don’t see “anti-age”. Does that mean that anti-age moisturizers are never considered OTC, or does it depend on the active ingredients?
    2) Regarding the skin bleaching, if a cream contains Arbutin, is it considered an OTC? So should it be tested according to the OTC/drug regulation?
    3) You say: “There are only 2 active ingredients acceptable for skin lightening.”…and what are these 2 ingredients?

    Thank you for this interesting article!!

    1. Avatar
      Perry Romanowski

      Hello –

      1. Anti-age is not a thing at least in terms of regulations. It refers more to a series of conditions like wrinkles, age spots, etc. Products that fix these problems are what get OTC.

      2. Arbutin has not been approved as an OTC skin bleaching active. There wasn’t enough proof to demonstrate it’s effectiveness (at least as far as the FDA is concerned). So products that contain Arbutin are not allowed to claim that they lighten skin.

      3. Hydroquinone is the only acceptable ingredient for skin lightening. That was a mistake in the blog post.

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  8. Avatar

    Hello. I had a question about Minoxidil. If I wanted to start a private label with a 2% and a 5% solution, would I fall under a monograph or would I have to file an NDA?

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  11. Avatar

    Mark, it isn’t just the US that has that problem. We see it over in Europe, and yes, I’ve been asked to match Licenced product claims, but for toiletries products

  12. Avatar
    Mark Fuller

    What amazes me is that there exist so many Cosmetic Formulations out there that are really OTC’s and not properly registered or monograph compliant. With the smaller clients I am working with, I am constantly called to look at these non compliant products and answer “Why can’t we do it they can?” I am sure I am not alone in what I am seeing.

    1. Avatar

      Yeah, that does seem like a bit of a problem.

    2. Avatar

      This is true and you may go to market in violation of the law. However, just because some other company has not gotten caught and fined doesn’t mean you won’t. Its like speeding on the highway. That they don’t catch them all is no defense when you get caught.

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