SPF moisturizers, tinted sunscreens, acne treatments and antiperspirants sit on the beauty shelf but are regulated by FDA as over-the-counter drugs. Their fulfillment needs drug-grade discipline on lots and expiry.
Why OTC beauty is regulated differently
In the United States, a product intended to protect against sunburn, treat acne, reduce perspiration or control dandruff is regulated as an over-the-counter drug, even when it is sold and marketed as beauty. That is why these products carry a Drug Facts panel.
Products that are both cosmetics and drugs are generally subject to drug requirements, and most of MoCRA's new cosmetic provisions do not apply to them in the same way. Drug manufacturing rules require lot numbers and, in most cases, expiration dates on OTC products, which makes lot and expiry control in the warehouse essential.
We treat OTC beauty SKUs as their own class: lot and expiry required at receipt, FEFO enforced, and holds applied automatically when product approaches its expiration window. FDA-registered facilities are available in select markets for brands whose programs require them.
Seasonality and expiry planning
Sunscreen demand is seasonal, and that creates expiry risk. Brands build inventory ahead of summer, and product that does not sell through may carry into the next season with less remaining life.
Lot and expiry reporting by SKU helps planning teams see how much shelf life remains before the season starts, so they can steer older lots to DTC promotions or value sets while retail receives longer-dated stock. Retail minimum shelf-life rules are enforced automatically during allocation.
Spray sunscreens are typically aerosols and follow the same SDS-based classification and limited-quantity ground shipping as other beauty aerosols. Year-end lot reviews help brands decide early what to do with product that will not have enough remaining life for the next season.
Recall readiness for drug-cosmetics
OTC products carry stricter expectations for traceability, and recalls in sunscreen and other OTC categories have shown how important it is to know exactly which lots reached which customers.
We report every order, customer and retail shipment that received a given lot, apply immediate quarantine holds across markets, and keep records of holds, releases and destructions. Those records support your quality and regulatory teams in responding quickly and precisely, limiting any recall to the batches truly affected.
Returned OTC products are handled conservatively: opened or damaged units are not restocked, and returns linked to complaints can be held for your quality team. Every disposition is recorded by lot, so your documentation stays complete from receipt to final outcome.
Frequently asked questions
Is sunscreen a cosmetic or a drug?
In the U.S., sunscreen is regulated by FDA as an over-the-counter drug, which is why it carries a Drug Facts panel, even when it is sold as a beauty product.
Does MoCRA apply to SPF moisturizers?
Products that are both cosmetics and drugs are generally subject to drug requirements, and most of MoCRA's new cosmetic provisions do not apply to them the same way. Confirm details with regulatory counsel.
Can you ship spray sunscreen?
Yes. Spray sunscreens are typically aerosols, classified from their Safety Data Sheet and shipped by ground as limited quantities where eligible.