FDA 21CFR 878.4635
“Contraindication: This product is contraindicated for
use on persons under the age of 18 years.”
“Contraindication:
This product must not be used if skin lesions or open wounds are present.”
“Warning: This product should not be used on
individuals who have had skin cancer or have a family history of skin cancer.”
“Warning: Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer.”