Sunscreen
Any product that is identified as "sunscreen" is an over-the-counter drug. To be legal, the product must:
- Be manufactured in a facility that is approved as a drug manufacturing facility.1
- Use only approved active ingredients2
- Use only approved label statements.3
- Be tested (using specifically required tests) to determine or verify the SPF level and degree of water resistance.4
What about titanium dioxide and zinc oxide?
Titanium dioxide and zinc oxide (both up to 25%) are approved as active ingredients in a sunscreen.
However, just adding 25% of either one to a lotion or cream does NOT meet all the requirements for a sunscreen to be legally marketed. Creating an effective sunscreen using titanium dioxide or zinc oxide is difficult and requires advanced formation to ensure that the active ingredient is sufficiently dispersed, effectively held in suspension, and stable.
Even if your product contains 25% titanium dioxide or zinc oxide, stating or implying that is an effective sunscreen is illegal unless the product has been tested, properly labeled, and manufactured in a registered drug manufacturing facility.
1 FDA. Registration and Listing, Section: Drugs.
2 FDA. Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use. 2021.Part B
3 Ibid, Part C
4 Ibid, Part D
