Petrolatum used at 30%–100% concentration with lip protectant claims (e.g., 'relieves chapped lips') triggers the FDA OTC lip protectant drug monograph in the United States. This requires compliant labeling with active ingredient declaration and drug facts panel. Your formulator must understand this distinction. EU Cosmetics Regulation (EC 1223/2009) governs the same product in Europe without OTC drug status.
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