How Health Canada and the FDA Approach Cosmetics Differently

The US FDA regulates cosmetics primarily under the Federal Food, Drug, and Cosmetic Act. Historically, this framework has required manufacturers to ensure their products are safe, but it has not required pre-market approval or maintained a published list of banned ingredients equivalent to Health Canada's Hotlist. 

Health Canada's approach under the Food and Drugs Act and the Cosmetic Regulations includes a published, searchable Cosmetic Ingredient Hotlist — a formal document listing ingredients that are either completely prohibited in Canadian cosmetics or restricted to specific product types, maximum concentrations, or mandatory warning labels. This list is updated regularly, most recently in August 2025.

The key takeaway here is that a product sold legally in the US may contain ingredients that are not permitted in Canadian cosmetics, particularly in leave-on product formats, at concentrations allowed in the US, or without the cautionary language Canadian regulations require.

When you buy from a Canadian retailer selling Canadian-market products, Health Canada's framework applies. When you buy from US sellers on cross-border platforms or through US-based websites, you may be receiving a product that was never formulated or reviewed for Canadian compliance.

 

Specific Ingredients and Restrictions Worth Knowing

Methylisothiazolinone (MI) in Leave-On Products

This is one of the clearest examples of a Health Canada restriction that differs from what you'll find in many mainstream US products.

Methylisothiazolinone (MI) is a preservative widely used in personal care products. It has been associated with allergic contact dermatitis, and the scientific literature identifying it as a significant sensitizer — particularly for children with reactive or eczema-prone skin — is well established.

Under current Health Canada cosmetic regulations, MI is not permitted in leave-on cosmetic products. In rinse-off products, it is permitted only at a maximum concentration of 0.0015%. The same restriction applies to the combination preservative MI/MCI (methylisothiazolinone/methylchloroisothiazolinone).

This means a leave-on lotion, cream, or moisturizer sold by a US brand that contains MI is not compliant with Canadian cosmetic standards — even if it's being shipped to Canada or sold through an online marketplace.

For parents managing eczema, this matters. The diaper area, in particular, is a high-risk zone: wet wipes and leave-on diaper creams are both products where MI has historically appeared and where a child's skin is already under barrier stress.

Retinoids and Retinol Concentration Limits

Retinoids appear on Health Canada's restricted list with specific concentration limits depending on product format. Retinol and its esters are restricted to 0.2% in leave-on products intended for full-body application, and 1.0% in other cosmetics. Retinal (retinaldehyde) is restricted to 0.01% in leave-on full-body products and 0.05% in others.

In the US, retinol concentrations in over-the-counter cosmetics are not regulated at the same level — some products market themselves at concentrations well above what Health Canada would permit in a leave-on format.

For pregnancy and infant use, retinoid avoidance remains the standard recommendation regardless of jurisdiction. But for parents shopping for adult skincare and wondering why a highly reviewed US retinol product looks different from Canadian equivalents, this is part of the reason.

Salicylic Acid Concentration Cap

Salicylic acid is restricted to a maximum of 2% in Canadian cosmetics. This is relevant  for parents shopping for acne treatments, exfoliating products, or anti-dandruff shampoos, particularly for adolescents or anyone with reactive skin. Some US formulations exceed this level.

Talc and Cautionary Labelling Requirements

Health Canada's hotlist includes important restrictions on talc-containing products, particularly those that may come into contact with the genital area or be used for diapering. Products in loose powder form that may be used for diapering must carry specific labelling that includes "Keep out of reach of children" and guidance about keeping powder away from the child's face to avoid inhalation.

Talc is not permitted in products intended solely for use in the genital area of those who have ovaries. Products that could contact the genital area must carry a warning label to that effect.

Baby powder products sold in the US may not carry equivalent mandatory warnings. If you've ever wondered why Canadian-market baby powder looks different from a product you saw recommended online by a US source, labelling requirements are part of the answer.

Formaldehyde-Releasing Preservatives

Formaldehyde itself is restricted in Canadian cosmetics to low concentrations depending on product type, and is not permitted in aerosol products. What many parents don't realize is that some preservatives commonly used in baby and skincare products release small amounts of formaldehyde as they break down — including ingredients like DMDM hydantoin, imidazolidinyl urea, and diazolidinyl urea.

Health Canada's framework addresses formaldehyde through concentration limits and labelling, but the Hotlist approach doesn't automatically flag every formaldehyde-releasing preservative the same way. This is one area where parents benefit from reading ingredient lists themselves, rather than relying on regulatory compliance alone to filter everything out.

Sunscreen Ingredients and Labelling

Sunscreen regulation in Canada differs meaningfully from the US, though the picture is more nuanced than a simple "more banned ingredients" comparison.

In Canada, sunscreens are regulated as either non-prescription drugs or natural health products, depending on their active UV filters. Mineral-only sunscreens using zinc oxide or titanium dioxide are classified as natural health products and require a Natural Product Number (NPN). Chemical UV filter products follow a drug submission pathway with a Drug Identification Number (DIN).

Health Canada's sunscreen monographs — updated most recently in late 2025 — specify which UV filter ingredients are permitted, at what concentrations, and under what labelling conditions. These permitted lists and their approval pathways differ from the FDA's OTC sunscreen monograph. Some UV filters permitted in Canada are not yet approved in the US, and vice versa.

The practical takeaway for parents is that a US sunscreen product, particularly one marketed for babies or sensitive skin, may use UV filter ingredients or formulations that don't align with Canadian market standards. When choosing sunscreen for your child, look for Canadian-market products with an NPN or DIN on the label.

 

What Amazon and Cross-Border Shopping Actually Means for Compliance

This is where things get practical. When you order a skincare product from a US seller on Amazon, you are typically receiving a product formulated and labelled for the US market. That product:

• Was not submitted to Health Canada for review

• May contain concentrations of restricted ingredients that exceed Canadian limits

• May not carry the cautionary language Health Canada requires

• May include leave-on products with preservatives not permitted in leave-on cosmetics in Canada

Canadian customs does not systematically screen personal care products at the individual purchase level. The result is that products not meeting Canadian standards enter Canadian homes routinely, and parents have no way to know this unless they recognize specific ingredient names on the label.

 

A Practical Checklist for Canadian Parents

Even when shopping within Canada, the regulatory system is not a substitute for reading labels. Here's what to check:

• Methylisothiazolinone (MI) — should not appear in any leave-on product for children

• Fragrance or parfum — a trade secret entry that can represent dozens of undisclosed compounds; choose fragrance-free for sensitive or eczema-prone skin

• Formaldehyde-releasing preservatives — DMDM hydantoin, imidazolidinyl urea, diazolidinyl urea; worth checking especially in rinse-off products

• Retinol concentration — in leave-on products, Canadian limits apply; check if a US-sourced product exceeds these

• Sunscreen NPN or DIN — confirms the product went through Health Canada's review process

• Talc in powder products — should carry appropriate Canadian cautionary labelling

• Salicylic acid above 2% — not compliant with Canadian cosmetic limits in leave-on formats

If a product doesn't list its country of manufacture, doesn't have an NPN or DIN where applicable, or doesn't carry standard Canadian labelling in both English and French, it likely wasn't reviewed for the Canadian market.

 

Why This Matters for Families Using by Dr. Mom

All by Dr. Mom products are formulated and manufactured in Alberta to Canadian standards. That means the formulations have been developed with Health Canada's Cosmetic Ingredient Hotlist in mind — no MI in leave-on products, no fragrance, no ingredients that require the kind of cautionary labelling that signals elevated risk.

For families managing eczema, sensitive skin, or newborn skincare routines, knowing your products were built for the Canadian regulatory framework removes one layer of guesswork from an already complicated landscape. Explore the full range at bydrmom.com.

 

The Bottom Line

Health Canada's cosmetic regulations offer genuine protections — particularly through the Ingredient Hotlist's leave-on restrictions, concentration caps, and labelling requirements. But no regulatory system catches everything, and cross-border shopping bypasses the system entirely.

The most reliable safeguard is reading ingredient labels yourself, knowing what to look for, and choosing products that were made for the Canadian market by manufacturers who designed them with Canadian standards in mind.

Your child's skin doesn't know the difference between a Canadian label and a US one. But now you do.

REFERENCES: 

Scherrer, M. A. R., Rocha, V. B., & Andrade, A. R. C. (2015). Contact dermatitis to methylisothiazolinone. Anais Brasileiros de Dermatologia, 90(6), 912–914. https://doi.org/10.1590/abd1806-4841.20153992

Health Canada. (2025). Cosmetic Ingredient Hotlist. Government of Canada. Cosmetic Ingredient Hotlist