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Over-the-counter medicine · no prescription needed

Octisalate

Purpose on the label: Sunscreen

Sunscreens

Official FDA data, not advice

The label text is quoted exactly as the company filed it with the U.S. Food and Drug Administration (FDA), with a link to the official copy. The list of brands comes from the FDA NDC Directory.

This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.

If someone may have taken too much, call Poison Help: 1‑800‑222‑1222. In an emergency, call 911.

Quick answers

What is Octisalate used for?
The Drug Facts label of Arizona Sun Tanning Oil SPF 3 (Arizona Sun Products) lists these uses: Helps provide mimial protection agains sunburn. Higher SPF gives more sunburn protection. For skin that sunburns minimally..
Do I need a prescription for Octisalate?
No. The products on this page are sold without a prescription (over the counter).
Is a store brand the same as the name brand?
Products listed together below have the same active ingredient, in the same amount and the same form, as registered with the FDA. Inactive ingredients (such as colors, flavors and fillers) and package sizes can differ. Compare the “Active ingredient” box on both packages, and ask a pharmacist if you are not sure.
Has Octisalate been recalled?
No recall linked to these products appears in the FDA enforcement reports we use.

Drug Facts label

Every over-the-counter medicine must carry a “Drug Facts” box in the same order, set by FDA rules. Below is the label of one product for each common strength and form, quoted word for word. Your own package can differ (for example, children’s products have other directions): always follow the label on your package.

Arizona Sun Tanning Oil SPF 3 · Arizona Sun Products

Octisalate 5%, oil (topical)

Active ingredient

Ethylhexyl Salicylate (5.00%)

Purpose

Sunscreen

Uses

Helps provide mimial protection agains sunburn. Higher SPF gives more sunburn protection. For skin that sunburns minimally.

Warnings

For external use only. Do not swallow. Avoid contact with the eyes. If contact occurs, rinse eyes thouroughly with water.

When using this product

keep out of eyes. Rinse with water to remove. Keep out of the reach of children. If swallowed get medical help or contact a poison control center right away.

Stop use and ask a doctor if

rash or irritation develops and lasts.

Directions

Drug Facts

Other information

Sun Alert: Limiting sun exposure, wearing protective clothing, and using suscreen may reduce the risk of skin aging, skin cancer and other harmful effects of the sun.

Inactive ingredients

Mineral Oil, Isopropyl Palmitate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Tocopheryl Acetate (Vitamin E), Simmondsia Chinensis (Jojoba) Seed Oil, Aloe Barbadensis Leaf (Aloe Vera) Extract, Rosa Canina Flower (Rose Hips) Extract, Salvia Officinalis (Sage) Leaf Extract, Verbascum Thapsus (Mullein) Extract, Lupinus Luteus Seed (Lupin) Extract, Humulus Lupulus (Hops) Extract, Cereus Grandiflorus (Cactus) Extract, Arctium Lappa Root (Burdock) Extract, Helianthus Annuus (Sunflower) Seed Extract, Viscum Album (Mistletoe) Fruit Extract, PEG-4 Dilaurate, BHT, Fragrance, Violet 2, Red 17, Yellow 11.

Questions?

Call toll free 1-800-442-4786

— FDA label of Arizona Sun Tanning Oil SPF 3, Arizona Sun Products, effective April 9, 2026. See the official label on DailyMed →

Maybelline New York Fit Me Dewy Plus Smooth Foundation Spf 18 Sunscreen · LOreal USA Products Inc

Octisalate 50 mg/mL, lotion (topical)

Active ingredient

Octisalate 5%

Purpose

Sunscreen

Uses

helps prevent sunburn

Warnings

For external use only

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash occurs

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

  • apply apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months of age: Ask a doctor

Inactive ingredients

water, dimethicone, glycerin, isododecane, isotridecyl isononanoate, propanediol, butyloctyl salicylate, PEG-10 dimethicone, PEG-9 polydimethylsiloxyethyl dimethicone, niacinamide, trimethylsiloxysilicate, synthetic fluorphlogopite, phenoxyethanol, dimethicone/polyglycerin-3 crosspolymer, disteardimonium hectorite, sodium chloride, disodium stearoyl glutamate, chlorphenesin, tocopherol, trisodium ethylenediamine disuccinate, ethylhexylglycerin, aluminum hydroxide, maltodextrin, citric acid, sodium hyaluronate, ascorbyl glucoside, dipropylene glycol, alpha-isomethyl ionone, camellia sinensis leaf extract; may contain: titanium dioxide, iron oxides

Questions?

1-800-322-2036

— FDA label of Maybelline New York Fit Me Dewy Plus Smooth Foundation Spf 18 Sunscreen, LOreal USA Products Inc, effective June 16, 2026. See the official label on DailyMed →

This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.

Same medicine, other brands

Each group lists the products that have exactly the same active ingredient, in the same amount and form, as registered with the FDA (NDC Directory). A store brand in the same group has the same medicine as the name brand; inactive ingredients, flavors and package sizes can differ. Each product links to its own official label.

Octisalate 5% · oil (topical) · 1 product

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Arizona Sun Tanning Oil SPF 3 Arizona Sun Products DailyMed
Octisalate 50 mg/mL · lotion (topical) · 1 product

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Maybelline New York Fit Me Dewy Plus Smooth Foundation Spf 18 Sunscreen LOreal USA Products Inc DailyMed

Companies that sell this medicine

The company named on the package (maker or distributor), as listed in the FDA NDC Directory, with its number of over-the-counter products of this medicine.

  • Arizona Sun Products1 product
  • LOreal USA Products Inc1 product

Recalls

No recall linked to these products (by their NDC code or label) appears in the FDA enforcement reports.

Sources

  1. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  4. FDA rule for the Drug Facts label (21 CFR 201.66)

Only medicines marketed under FDA rules for nonprescription drugs (an FDA monograph or an FDA approval) are listed. Homeopathic products are not listed: the FDA does not evaluate them for safety or effectiveness.

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