Over-the-counter medicine
Zinc oxide
Zinc oxide is an over-the-counter medicine. No generic is listed; pharmacies paid $0.0611 per gram (Zinc oxide 20% ointment) in the October 7, 2026 NADAC survey.
- No generic listed
- Over the counter
Check it at the source: the zinc oxide FDA label on DailyMed (effective April 29, 2024); every zinc oxide label on DailyMed.
Highlights of the record
FDA label of April 29, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagehelps prevent sunburn
if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.
Forms and strengths
- 2.1483 g/34.65g
- 15 g/100ml
- 15 g/100g
- 17.5 g/100g
- 20 g/100g
- 20 g/100ml
- 24 g/100g
- 25 g/100g
- 40 g/100g
- 67 mg/ml
- 100 mg/ml
- 110 mg/ml
Cream; lotion; stick; ointment; liquid.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 812 of which 0 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0611 per gram Zinc oxide 20% ointment
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2020 1 Class I among all firms' recalls; 12 more by firms not listed as its makers
- FAERS reports
- 2,647 through July 30, 2026
What is zinc oxide used for?
From the label: indications and usagehelps prevent sunburn
if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.
Source: FDA drug label (bareMinerals BAREPRO 24HR Wear Skin-Perfecting Matte Liquid Foundation Fair 10 Neutral), Orveon Global US LLC, effective April 29, 2024 (SPL set 1740393b-f8a3-475b-e063-6394a90a6fa8), via openFDA; the full label on DailyMed
Is there a generic for zinc oxide?
No generic zinc oxide is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for zinc oxide?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0611 per gram (Zinc oxide 20% ointment), up 33% from $0.0458 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Zinc oxide 20% ointment (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Calamine suspension | Generic | $0.011 per mL | n/a | +0.8% |
| Diaper rash 40% ointment | Generic | $0.0339 per gram | n/a | +5% |
| Gnp zinc oxide 20% ointment | Generic | $0.0364 per gram | n/a | +17% |
| Hm calamine lotion | Generic | $0.011 per mL | n/a | +0.8% |
| Sm calamine lotion | Generic | $0.011 per mL | n/a | +0.8% |
| Z-bum 22% diaper rash cream | Generic | $0.368 per gram | n/a | +6% |
| Zinc oxide 20% ointment | Generic | $0.0611 per gram | n/a | +33% |
| Zinc oxide 22% cream | Generic | $0.368 per gram | n/a | +6% |
| Zinc oxide 25% ointment | Generic | $0.0445 per gram | n/a | +17% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has zinc oxide been recalled?
The FDA's Enforcement Report lists 12 recalls naming zinc oxide since 2020: 1 Class I (the most serious), 8 Class II, 3 Class III; 9 still ongoing. 12 of them are by firms that FDA's NDC Directory does not list as a maker of zinc oxide and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| October 31, 2025 | Class II | Blossom Pharmaceuticals not a listed maker | cGMP deviations |
| May 24, 2024 | Class I | SYNCHRONICITY SPA INC, DBA SUNTE not a listed maker | Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold) |
| May 24, 2024 | Class II | SYNCHRONICITY SPA INC, DBA SUNTE not a listed maker | CGMP Deviations |
| April 20, 2020 | Class III | Glaxosmithkline Consumer Healthcare Holdings not a listed maker | Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for zinc oxide?
The FDA Adverse Event Reporting System holds 2,647 reports that list zinc oxide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 264 are coded as a death and 1,230 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Zinc oxide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other