Hands, Face, Neck — Here’s How to Even Out Skin Tone

A 2020 Law Moved Hydroquinone Creams Behind an Approval Gate

Dark spots on the face, hands and neck are described in two vocabularies. Regulators describe the products sold for them by ingredient and legal status. Dermatologists describe the spots themselves by cause and by depth in the skin.

This week's news touched both. A journal digest on Wednesday summarized a study of online skin products, some marketed for hyperpigmentation, that held a prescription-strength steroid not named on the label. Regulators abroad, meanwhile, kept adding imported lightening creams to mercury advisories.

For decades, many over-the-counter drugs were sold under monographs, rulebooks listing allowed ingredients, strengths and label wording. A product that followed one needed no individual approval.

The CARES Act, Public Law 116-136, signed March 27, 2020, added section 505G to the Federal Food, Drug, and Cosmetic Act and converted that system into administrative orders. Hydroquinone skin lighteners did not carry over. FDA states that since enactment, such products "are deemed to be new drugs and are misbranded."

The agency set a date. Effective Sept 23, 2020, makers and distributors of over-the-counter skin lightening products without FDA approval were to remove them from the market.

Enforcement followed on April 19, 2022. FDA issued warning letters to 12 companies selling hydroquinone products without a prescription and asked each to respond within 15 days. It also added certain manufacturers to an import alert to keep their products out of the country.

FDA also said it had received reports of serious side effects, including skin rashes, facial swelling and ochronosis, a blue-black discoloration it says may be permanent.

Hydroquinone itself remains in medicine. FDA identifies a single approved drug containing it, a prescription combination cream for short-term treatment of dark spots tied to moderate to severe melasma of the face, to be used under the supervision of a licensed health care professional.

Hydroquinone is one concern; mercury is the other. FDA says it "does not allow mercury in drugs or in cosmetics, except under very specific conditions," and that the lightening products it tested do not meet them.

The agency's table, current as of Aug 24, 2026, lists 7 products tested in 2019, 15 in 2022 and 8 in 2026. Mercury readings run from 47 ppm to 27,762 ppm. Five of the 2022 products also contained hydroquinone, at 1.2% to 4.4%.

FDA describes the harm in terms of absorption. Repeated application can let mercury enter the bloodstream, with risks that include kidney damage and nerve effects such as tremors, tingling, numbness, headaches, fatigue and changes in mood or thinking. The agency says risk rises with longer and more frequent use, and names children and pregnant people as facing greater risk.

An older FDA consumer page lists label words that signal mercury: "mercurous chloride," "calomel," "mercuric," "mercurio" and "mercury." It advises against any product with no label.

The Philippine advisories this month, and the 1 ppm ASEAN limit cited alongside them, describe the same supply chains from the other end.

Dermatology does not treat dark spots as one condition. Three common patterns carry different names and associations.

Solar lentigines, often called age spots or liver spots, are described by Harvard Health Publishing as collections of pigment caused by sun exposure. They commonly appear on the hands and other sun-exposed areas, are most common after 55 and are described as not harmful.

Melasma is described by the National Library of Medicine's StatPearls review, updated Jan 31, 2026, as symmetric brown-to-gray patches with irregular borders, mainly on sun-exposed facial skin. Series show a marked predominance in women, and Fitzpatrick skin types III to V are disproportionately affected.

The review links melasma onset or worsening to ultraviolet and visible light, pregnancy and outside estrogen or progesterone. It cautions that these are associations, and that causality cannot be inferred from cross-sectional data. Historically, a Wood lamp sorted melasma as epidermal, dermal or mixed; the review now calls those findings inconsistent in darker skin.

Postinflammatory hyperpigmentation, in a StatPearls entry updated Nov 25, 2024, follows skin inflammation or injury such as acne, eczema, burns or peels. It is more common and more severe in darker skin. Pigment held in the outer layers looks brown, while pigment that reaches the dermis looks blue-gray and lasts longer.

The melasma review adds one more entry to the list of look-alikes: exogenous ochronosis, a paradoxical blue-black pigmentation seen with long-term hydroquinone exposure. The same word appears in FDA's 2022 letters.