1. Introduction: are salicylates safe in pregnancy?

2. Which Salicylates are banned in sunscreens due to safety issues in pregnancy?

3. Should you avoid all salicylates in pregnancy and in young children? Reviewing the safety of Octisalate, butyloctyl salicylate, tridecyl salicylate, and homosalate in pregnancy

4. Pregnancy safe sunscreen recommendations

Introduction: are salicylates safe in pregnancy?

Understanding Pregnancy-Safe Sunscreens: When it comes to pregnancy, many expectant mothers are rightfully cautious about the products they use, including sunscreen. Sun protection is arguable the most important skincare product for an expectant woman considering the heightened sensitivity of the skin during pregnancy and in the increased risk for hyperpigmentation known as melasma, sometimes called mask of pregnancy. But what truly makes a sunscreen pregnancy safe, going beyond simple marketing claims or generic free from claims of ‘harsh chemicals’? The truth is that expectant mothers very often are much more stringent with the products they use topically as the risk for skin absorption and potential impacts on the fetus are higher table stakes. Let’s take a look at up-to- date thinking and concerns regarding salicylates in sunscreens (including octisalate, homosalate, butyloctyl salicylate, tridecyl salicylate) ingredients around the world according to major regulatory bodies.

Which Salicylates are banned in sunscreens due to safety issues in pregnancy?

The FDA in 2019 as part of their proposed update to the sunscreen monography declared that two UV filters would no longer be permitted as they did not and would not likely ever meet the criteria for being considered Generally Recognized as Safe and Effective. Alongside PABA, trolamine salicylate is prohibited due to concerns of “serious bleeding and salicylate toxicity (vomiting, hyperventilation, metabolic disturbances, coma and death) when this ingredient is used in sunscreens.” The concern is that widespread use over the body with repeated applications could reach a threshold for salicylate toxicity. However, since the FDA did not have any sunscreens registered with them at the time of the proposal that used trolamine salicylate as an active ingredient, the impact of the prohibition was limited.

Should you avoid all salicylates in pregnancy and in young children? Reviewing the safety of octisalate, butyloctyl salicylate, tridecyl salicylate, and homosalate in pregnancy

However, should pregnant women be concerned about other salicylate ingredients in their sunscreens. Salicylates can appear in both the active and inactive portion of a sunscreen ingredient list. All forms of salicylates in sunscreens including octisalate, homosalate, butyloctyl salicylate, and tridecyl salicylate have robust data to show they permeate through skin into blood. When it comes to recognized active UV Filters, homosalate and octisalate (ethylhexy salicylate) are two of the most common UV Filters for UVB absorption. Within the inactive ingredients, butyloctyl salicylate (BOS) and tridecyl salicylate are also very commonly used in sunscreens that are both labelled as ‘all-mineral’ and ‘chemical’ formulas. The Therapeutic Goods Administration in Australia recommended that butyloctyl salicylate not be used in concentrations above 1% and not be used by women who are in their last term of pregnancy or by children under 4 years of age.

The EU considers salicylic acid a Grade 2 reprotoxicant, meaning int can cause changes to the unborn child, and limit concentrations in leave-on cosmetics to 2% and prohibit their use for children under 3 years. It is currently reviewing its position for the safety of salicylates in children 3-11. The EU has also as of June 2021, deemed homosalate on the basis of endocrine disruption to NOT be safe when used in concentrations higher than .5% in sunscreens. They also prefaced this opinion with the fact that they did NOT look at the potential effect of combining homosalate with other metabolites of salicylic acid.

The FDA does not currently have limitations on the amount of butylocctyl salicylate in a sunscreen since it is not considered a regulated active ingredient. According to a Cosmetic Ingredient Review safety assessment of salicylates, some lipsticks may contain up to 35% of butyoctyl salicylates. Typical sunscreen concentrations of BOS in the US can range from 1-5% but could be as high as 10%.

Consider the fact that a sunscreen formula can contain a blend of salicylate ingredients and that this blend of ingredients could range as high as 20-30% of a formula. The Cosmetic Ingredient Review also confirmed that salicylic acid (the metabolite of salicylates) cross the placenta and that salicylates are absorbed into the body and can in some cases bind to estrogen receptors meaning they are potential Endocrine Disrupting Chemicals.

With all of this in mind, it would make sense for pregnant women to avoid salicylates in their sunscreens and certainly avoid sunscreens that use them in combination. It remains almost impossible to properly calculate a NOAEL (No Observable Adverse Effect Level) for a foetus. In face, very low levels of a potential endocrine disrupting chemical may do more harm than a high dose.

The dose response curves in human endocrinology are non-monotonic, i.e. may be inverted U-shaped or reverse exponential. This means the common refrain of the ‘poison is in the dose’ does not apply when it comes to reproductive endocrinology for pregnant women and their unborn child. We cannot determine a harmful dose in this context.

- Dr. Denis Dudley, OB-GYN and reproductive endocrinologist and co-founder of The Sunscreen Co.

Pregnant women should avoid sunscreens that contain homosalate and octisalate in the active ingredients and butyolctyl salicylate and tridecyl salicylate to obviate concerns of systemic absorption and concerns related to salicylate dosage. It would also make sense for kids under the age of 4 to restrict their use of these types of sunscreens. However, we typically see sunscreens marketed as pregnancy safe or kid safe that include these ingredients and UV filters. You can consider asking your sunscreen brand what concentration of tridecyl salicylate and butyloctyl salicylate their formula contains and what evidence they have that current dosage is safe for pregnancy and young children. The unfortunate truth is that many brands may be unaware about the actual concentration of these additives as they purchased their formulas from contract manufacturers that did not disclose how similar these ingredients were to chemical UV filters.

Pregnancy safe sunscreen recommendations

All mineral sunscreens containing as close to the maximum concentration of zinc oxide (as close to 25% as possible) continue to be the safest and best choice for pregnant and nursing women and young children. There is robust data to show that zinc oxide does not penetrate past the dead layer of skin (even damaged skin). It provides excellent UVA, visible light and UVB protection when used in sufficient concentration. We recommend that pregnancy women and mothers also look at the inactive ingredients of their sunscreens and ensure it is free from butyloctyl salicylate and tridecyl salicylate due to concerns of absorption, contact with the foetus across the placental barrier, risk of endocrine disruption. Sunscreen brands should also never reduce the quantity of zinc oxide used and replace it with either of these ingredients as the UVA protection of the sunscreen will be impacted, leading to potential skin aging, pigmentation and certain forms of skin cancer.

Our Ava Isa line of mineral suncare offers highly aesthetic daily sunscreen options that contain 25% zinc oxide. They have high UVA protection factors to help with the prevention of pigmentation and melasma. They are easy to wear daily and are free from all salicylate ingredients (they are also free from other ‘chemical’ filters oxybenzone, octinoxate, avobenzone etc.). Our company was actually started with the premise of creating sunscreens and skincare that were safe for pregnant women to use and it remains a huge part of our company mission and criteria for formulating all our skincare products.

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References:

European Commission. (2021). Opinion on methyl salicylate (methyl 2-hydroxybenzoate). Scientific Committee on Consumer Safety. https://health.ec.europa.eu/system/files/2022-08/sccs_o_255.pdf

European Commission. (2019). Opinion on salicylic acid (CAS 69-72-7). Scientific Committee on Consumer Safety. https://health.ec.europa.eu/system/files/2021-08/sccs_o_223_0.pdf

Therapeutic Goods Administration. (2006). OTC MEDICINES EVALUATION SECTION ASSESSMENT OF NEW TOPICAL EXCIPIENT Butyloctyl salicylate. https://www.tga.gov.au/sites/default/files/foi-116-1516-07.pdf

Cosmetic Ingredient Review. (2019). Safety assessment of salicylic acid and related salicylates as used in cosmetics. https://www.cir-safety.org/sites/default/files/salicy042019FAR.pdf

Sunjin Beauty Science. (2023). Sunbos (Butyloctyl Salicylate). https://sunjinbs.com/?p=5960

Hallstar. (n.d.). HallBrite BHB. http://cntmp.hallstar.com/product/hallbrite-bhb/
European Commission. .(2021) Opinion on Homosalate. Scientific Committee on Consumer Safety. https://health.ec.europa.eu/system/files/2022-08/sccs_o_244.pdf