Salicylate Safety in Pregnancy: what is a pregnant safe sunscreen?
Introduction: are salicylates safe in pregnancy?
Which Salicylates are banned in sunscreens due to safety issues in pregnancy?
Should you avoid all salicylates in pregnancy and in young children? Reviewing the safety of Octisalate, butyloctyl salicylate, tridecyl salicylate, and homosalate in pregnancy
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.
Our recommendations for pregnancy safe sunscreens and why you should avoid salicylates in pregnancy
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 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 salicylates are absorbed into the body, cross the placenta 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. Pregnant women should avoid sunscreens that contain homosalte 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.
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.