Over-the-counter medicine
Octinoxate
Octinoxate is an over-the-counter medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Over the counter
Check it at the source: the octinoxate FDA label on DailyMed (effective March 13, 2025); every octinoxate label on DailyMed.
Highlights of the record
FDA label of March 13, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 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
- 0.9743 g/15g
- 1 g/100ml
- 1.995 g/100g
- 2.30805 g/30ml
- 2.5 g/100ml
- 6 mg/ml
- 30 mg/ml
- 32 mg/ml
- 35 mg/ml
- 68 mg/ml
- 70 mg/ml
- 75 mg/ml
Cream; emulsion; lotion; liquid; powder.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 11 of which 0 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 147 through July 30, 2026
What is octinoxate 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 (SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 110), SHISEIDO AMERICAS CORPORATION, effective March 13, 2025 (SPL set 393ce1fa-f188-45d0-a23e-2818de974995), via openFDA; the full label on DailyMed
Is there a generic for octinoxate?
No generic octinoxate 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 FAERS reports show for octinoxate?
The FDA Adverse Event Reporting System holds 147 reports that list octinoxate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6 are coded as a death and 23 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Octinoxate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other