Hydroquinone, Octinoxate, and Oxybenzone is a prescription medicine (Melanin Synthesis Inhibitor). The sections below reproduce one FDA label for it, named under "Label". Products in other forms, strengths or from other makers have their own labels, which can differ.
- Type
- Prescription only (Rx)
- Brand names
- NU-DERM BLENDER Skin Lightener and Blending, NU-DERM CLEAR Skin Bleaching and Corrector, NU-DERM SUNFADER Skin Lightener with Sunscreen (SPF 15) PABA FREE
- Drug class
- Melanin Synthesis Inhibitor
- Taken
- Topical
- Label
- Obagi Cosmeceuticals LLC, revised January 1, 2025 · full label on DailyMed
- Generic
- No · details
What it is used for
For the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.
Who should not take it (contraindications)
People with prior history of sensitivity or allergic reaction to this product or any of its ingredients should not use it. The safety of topical hydroquinone use during pregnancy or in children (12 years and under) has not been established.
Warnings
Hydroquinone is a skin-bleaching agent, which may produce unwanted cosmetic effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this product. Test for skin sensitivity before using by applying a small amount to an unbroken patch of skin and check within 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response, product should be discontinued and physician consulted. Close patient supervision is recommended. Warnings: Avoid contact with eyes, nose, mouth, and lips.In case of accidental contact, patient should rinse thoroughly with water and contact a physician. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity. Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people .
Precautions
(Also see WARNINGS ) Treatment should be limited to relatively small areas of the body at one time since some patients experience a transient skin reddening and a mild burning sensation, which does not preclude treatment. Pregnancy Category C Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether hydroquinone can cause fetal harm when used topically on a pregnant woman or affect reproductive capacity. It is not known to what degree, if any, topical hydroquinone is absorbed systemically. Topical hydroquinone should be used on pregnant women only when clearly indicated. Nursing Mothers It is not known whether topical hydroquinone is absorbed or excreted in human milk. Caution is advised when topical hydroquinone is used by a nursing mother. Pediatric Usage Safety and effectiveness in children below the age of 12 years have not been established.
Side effects (adverse reactions)
No systemic adverse reactions have been reported. Occasional hypersensitivity (localized contact dermatitis) may occur, in which case the product should be discontinued and the physician notified immediately.
Pregnancy
Category C Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether hydroquinone can cause fetal harm when used topically on a pregnant woman or affect reproductive capacity. It is not known to what degree, if any, topical hydroquinone is absorbed systemically. Topical hydroquinone should be used on pregnant women only when clearly indicated.
Breastfeeding
It is not known whether topical hydroquinone is absorbed or excreted in human milk. Caution is advised when topical hydroquinone is used by a nursing mother.
Use in children
Pediatric Usage Safety and effectiveness in children below the age of 12 years have not been established.
Is there a generic Hydroquinone, Octinoxate, and Oxybenzone?
No. The FDA has not approved a generic version yet.
Source: Drugs@FDA (via openFDA), checked October 29, 2026. Marketing status is what companies report to the FDA; whether a pharmacy stocks a product, and what your insurance covers, can differ.
Dosage:
we do not reproduce dosing instructions. The right dose depends on the person and the condition and is set by the prescriber or pharmacist. Dosage section of the full label.
Hydroquinone, octinoxate, and oxybenzone in the news
We have not covered this medicine yet. Latest news
Recalls
No recalls matched to this medicine in FDA enforcement reports from the last 3 years (or older ones still open). Search all recalls
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Source: FDA structured product labeling, retrieved through openFDA. Label text is shown as published by the FDA, without editing; long sections are shortened, marked […]. openFDA data are not validated for clinical use — always check the current label and ask a doctor or pharmacist about your own treatment. Set ID e5c450af-958e-41e3-9c2f-fda76b3596f5.