Tag: AHA

  • Private Label AHA/BHA Exfoliant Serum: Cosmetic or OTC Drug?

    A private label AHA serum (glycolic, lactic,
    mandelic) sold as a cosmetic exfoliant is a standard cosmetic that any
    competent cosmetic contract manufacturer can make. A BHA serum built on
    salicylic acid is the fork in the road: market it for acne treatment and the
    same 0.5–2% salicylic acid becomes an over-the-counter drug under 21 CFR Part
    333, which has to be made in an OTC drug facility, not a cosmetic one. Same
    molecule, different label wording, two completely different supply chains.

    If you are sourcing an acid exfoliant serum, the decision that controls your
    whole project is not the acid percentage or the bottle. It is the sentence you
    plan to print on the front of the carton. Get that right before you request a
    single quote, because it decides which kind of factory you are even allowed to
    talk to.

    What’s actually different between AHA and BHA for a founder?

    AHAs — alpha hydroxy acids — are water-soluble and work on the surface.
    Glycolic is the smallest molecule and penetrates most readily; lactic is
    gentler and doubles as a humectant; mandelic is larger and slower, which is why
    it suits reactive skin. BHA means beta hydroxy acid, and in practice that is
    salicylic acid: oil-soluble, so it travels into the pore rather than staying on
    the surface.

    For formulation, the practical gap is pH and compatibility. An AHA serum at
    5–10% is relatively forgiving to make. Salicylic acid has to sit at a low
    enough pH (roughly 3–4) to do anything, and combining AHA and BHA in one bottle
    — common in consumer products — means managing that pH against two actives at
    once and proving the result is stable. A manufacturer who under-buffers the
    formula ships an irritating product; one who over-buffers ships an inert one.
    That is a real reason the factory you pick matters.

    Chuffy the small round creature squints at two near-identical serum bottles labelled AHA and BHA, sweating.
    Chuffy discovers the two bottles that look identical are governed by two different rulebooks.

    The rule that decides everything: cosmetic or OTC drug?

    In the United States, what a product claims to do determines how it
    is regulated, not what is in it. Salicylic acid at 0.5–2% is a recognized
    over-the-counter acne active under
    21 CFR Part 333, Subpart D. The moment your product both
    contains that salicylic acid and makes an acne-treatment claim on the
    label, the FDA classifies it as an OTC drug. That product must be made under
    drug GMP (21 CFR Part 211) in an FDA-registered drug facility — a different
    category from a cosmetic manufacturer.

    Position the identical formula as a cosmetic — “exfoliates dead skin cells,”
    “visibly refines the look of pores,” “helps skin appear smoother” — and it is a
    cosmetic. A standard cosmetic contract manufacturer can make it. AHAs make this
    easier still: glycolic and lactic acid have no OTC drug monograph for
    exfoliation, so an AHA serum sold on appearance claims is cosmetic territory by
    default. The FDA’s own
    guidance on cosmetic labeling claims is the plain-English
    version of where that line sits, and the agency’s
    small-business
    compliance guide for topical acne drug products
    spells out what tips a
    salicylic acid serum into drug status.

    The trap is wording you would type without thinking. “Anti-acne serum,”
    “unclogs pores so breakouts stop,” “fights blemishes” — each of those reads as a
    drug claim, and a cosmetic factory cannot legally make the product behind it.
    Decide your claims first; they pick your factory for you.

    Chuffy holds up a marker in front of a giant product carton, frozen, unsure whether to write the word acne.
    One word on the carton — ‘acne’ — quietly moves the whole project into a different regulatory universe.

    White label vs custom formulation for an acid serum

    Once you have settled on cosmetic positioning, the next question is build
    route. The two industry terms are used loosely across suppliers, so it is worth
    being precise about what they mean at a specific factory. The figures below are
    Moe’s Group’s, confirmed by the owner; other manufacturers set their own.

    White label (ready-to-go / existing formula)
    An existing formula you brand as your own. Fastest to market because there
    is no development phase. At Moe’s Group the minimum order is 200 units, and
    nothing runs below 200.
    Private label (custom formulation)
    A formula developed for you — your actives, your acid blend, your pH and
    sensory target. It adds a formulation and sampling phase, so it takes longer.
    At Moe’s Group the minimum order is 1,000 units.
    Contract manufacturing
    The umbrella service: formulation, filling and labeling for a brand.
    Pricing, formula ownership and lead time are set per project, not by the term
    itself.

    The useful way to read this: an existing formula removes the development fee
    and the sampling lead time, which is why white label reaches shelves sooner. A
    custom acid serum is the route when you need a specific percentage, a particular
    AHA/BHA ratio, or a texture no stock formula gives you — and you are ordering at
    least 1,000 units. Do not assume one is simply “cheaper”; what you are really
    buying with white label is removed development time.

    Chuffy stands at a fork in a corridor, one door marked 200 and one marked 1000, scratching his head.
    The 200-unit door and the 1,000-unit door lead to very different timelines and very different bills.

    What to ask a manufacturer about an acid serum

    Acid serums expose whether a factory actually understands formulation or just
    fills bottles. Five questions separate them:

    • What final pH do you target, and how do you verify it batch to
      batch?
      A salicylic serum outside ~3–4 is either harsh or inactive.
    • How do you handle AHA and BHA together? Combining them is
      a stability and pH problem, not a mixing one.
    • What preservative system do you use, and do you run preservative
      efficacy testing?
      Low-pH aqueous serums still need it; it is not
      optional.
    • Do you run full stability testing before scale-up? Acid
      serums have a shorter comfortable shelf life than many formats.
    • Are you a cosmetic facility or an OTC drug facility? This
      is the one that decides whether they can legally make your product at all if
      you are making acne claims.

    Moe’s Group’s own
    skincare
    manufacturing page
    names salicylic acid in its cleanser work and AHA/BHA in
    its toner formats, and lists stability testing and packaging-compatibility
    checks as part of custom development — which is the kind of concrete answer the
    questions above are fishing for. Verified live 2026-10-22.

    Chuffy reads from a long checklist taller than he is while a patient lab technician waits with a clipboard.
    The five questions that tell a serum formulator apart from a bottle filler.

    Where a cosmetic manufacturer is the wrong fit

    The honest part. A cosmetic contract manufacturer — Moe’s Group included — is
    the wrong call in several real situations, and knowing which is yours saves
    weeks:

    • You want to make acne-treatment claims. A salicylic acid
      product marketed as an acne treatment is an OTC drug and needs a 21 CFR Part
      211 drug facility. Search specifically for OTC drug manufacturers; most cosmetic-only
      factories, Moe’s Group among them, are not set up for it.
    • You need fewer than 200 units. For a DTC market test below
      that, Moe’s Group is not the route. US-based
      AJ Cosmo Labs advertises
      glycolic acid serum runs it describes as starting around 100–500 units
      (their claim; facility registration not independently confirmed at
      publication, so verify before you rely on it).
    • You are price-led at 3,000+ units and open to offshore.
      Chinese manufacturers such as
      Skincraft Lab (Zhongshan;
      ISO 22716 and FDA CFSAN GMP certificates listed, valid through 2028) quote
      glycolic acid at 2/5/8% from roughly 500 units private label and 3,000 custom.
      The trade-off is lead time, import compliance and the certification bar you are
      comfortable with — verify the live certificate numbers in FDA FURLS yourself.
      (Competitor details checked 2026-10-22.)
    • You are filling tiny batches yourself. Buying
      cosmetic-grade glycolic from an ingredient supplier and hand-filling is legal
      at micro scale, but it breaks down the moment you hit retail, Amazon FBA
      testing and labeling, or MoCRA facility registration.

    Where a US-based cosmetic manufacturer like Moe’s Group does fit is the
    middle of that range: a cosmetically-positioned AHA or BHA serum, white label
    from 200 units or custom from 1,000, formulated, filled and labeled in one
    FDA-registered facility. If that is you, the
    product
    inquiry form
    is where a real conversation starts.

    Chuffy finally relaxes in a chair holding a single finished serum bottle, exhausted but smiling, surrounded by crumpled claim drafts.
    Chuffy gets his serum made — once he accepted the bottle was the easy part and the sentence on the label was the whole project.

    Frequently asked questions

    Can I add salicylic acid to my serum and still sell it as a cosmetic?

    Yes, if you make no acne-treatment claims. Describe it with appearance and
    feel wording (“exfoliates dead skin cells,” “helps skin look clearer”) and it is
    a cosmetic. Make an acne-treatment claim and the same ingredient makes it an OTC
    drug.

    What is the difference between AHA and BHA?

    AHAs (glycolic, lactic, mandelic) are water-soluble and work on the skin’s
    surface. BHA (salicylic acid) is oil-soluble and works inside the pore. Only the
    BHA carries an OTC drug monograph in the US when used with acne claims.

    What is the minimum order for a private label glycolic acid serum?

    It depends on the manufacturer. At Moe’s Group a white label (existing)
    formula starts at 200 units and a custom formulation starts at 1,000. Some
    offshore manufacturers quote from around 500.

    Do I need FDA approval for an exfoliant serum?

    No — the FDA does not approve cosmetics, and the word “approved” does not
    apply to them. A cosmetic serum is made in an FDA-registered facility. Only if
    your product is an OTC drug (an acne-claiming salicylic acid serum) does a drug
    GMP facility come into play.

    Can I combine AHA and BHA in one private label serum?

    Yes, and many consumer products do. The catch is formulation: the pH has to
    work for both acids and the finished product has to pass stability and
    preservative efficacy testing. Ask a prospective manufacturer how they handle
    it before you commit.