Table 4: Practical considerations for emollient product selection.

Efficacy considerations

(i) Appropriate tests should testify to the efficacy of the product formulation

Safety considerations: overall

(i) The margin of safety for each ingredient at the concentration used in the formulation should be considered
(ii) Ingredients in a product can behave differently than in isolation; therefore, it is important to evaluate the full formulation for safety and
potential dermal effects, including irritation and sensitization

Safety considerations: fragrance

(i) The use of fragranced products for healthy neonates and infants should be supported by evidence for safety and tolerance
(ii) Fragrances should be compliant with the International Fragrance Association (IFRA), which is a body that helps to ensure the safety of
fragrance materials

Safety considerations: preservatives

(i) Products should be microbiologically robust
(ii) “Natural” does not always mean safer (e.g., some natural oils (eucalyptus, sage, and tea tree oils) can be toxic at certain levels)
(iii) Preservative ingredients can be natural or synthetic as long as their safety profile is documented; identical chemical structure means
identical safety profile

Safety considerations: labeling and packaging

(i) Directions for product use should communicate and educate parents on safe and appropriate use
(ii) Package design should help to minimize product contamination (e.g., loose top or seal could expose product to microbes)