Checked
Sunscreen
Sunscreen is an over-the-counter drug, made by 2 manufacturers.
- Type
- Over the counter
- Drug class
- Not classified
- Route
- Topical
- Manufacturers
- 2
helps 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
Related recalls
FDA drug recalls that name this drug or its active ingredient
- Class IIDrugOngoing09/09/2026THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%)...Allies Group Inc. · 4 products · Subpotent Product: Firm Testing indicated the affected product may...
- Class IDrug09/21/2022Banana Boat hair & scalp defense, Clear Sunscreen Spray SPF 30, Avobenzone 2.0%, Homosalate 6.0%...Edgewell Personal Care Brands, LLC · Chemical contamination: presence of benzene
- Class IDrug10/27/2021Coppertone SPORT Sunscreen Spray 50, (To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 5%...Beiersdorf Inc · Chemical contamination; presence of benzene
- Class IDrugOngoing10/06/2021Aveeno Protect + Refresh sunscreen weightless spray with oat SPF 60, Avobenzone (3%), Homosalate (10%)...Johnson & Johnson Consumer, Inc. · 20 products · cGMP Deviations
- Class IIDrug11/25/2020(Malin+Goetz) spf 30 face moisturizer (Avobenzone 3%, Homosalate 10 %, Octinoxate 7.5%, Octisalate 2.75%...Milbar Laboratories, Inc. · GMP Deviations
Active ingredients
Avobenzone 3% Homosalate 12% Octisalate 5%
Purpose
Sunscreen
Uses
Helps 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
Directions
Apply liberaly 15 minutes before sun exposure apply to all skin exposed to the sun reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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 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
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
Rash occurs
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away.
Side effects (adverse reactions)
DISTRIBUTED BY OLD EAST MAIN CO. 100 MISSION RIGDE GOODLETTSVILLE, TN 37072 100% Satisfaction Guaranteed! (888) 309-9030
Other information
Protect the product in this container from excessive heat and direct sun
Inactive ingredients
Water, diethylhexyl 2,6-naphthalate, butyloctyl salicylate, styrene/acrylates copolymer, aluminum starch octenylsuccinate, glycerin, polyester-7, silica, chlorphenesin, arachidyl alcohol, beeswax, neopentyl glycol diheptanoate, acrylates/C10-30 alkyl acrylate crosspolymer, behenyl alcohol, tocopherol, arachidyl glucoside, glyceryl stearate, PEG-100 stearate, potassium hydroxide, benzyl alcohol, disodium EDTA, sodium ascorbyl phosphate, fragrance
Forms and strengths
From the FDA NDC Directory · 2 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Lotion | 30 mg/mL / 120 mg/mL / 50 mg/mL | topical | 2 |
Manufacturers and labels
2 FDA labels
- Old East Main Co.Shown hereM020 · Label 03/03/2026 · NDC 75712-950Full label
- Retail Business Services, LLCM020 · Label 02/06/2026 · NDC 72476-951Full label
Sunscreen: common questions
- What is Sunscreen used for?
- helps 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
- What are the side effects of Sunscreen?
- DISTRIBUTED BY OLD EAST MAIN CO. 100 MISSION RIGDE GOODLETTSVILLE, TN 37072 100% Satisfaction Guaranteed! (888) 309-9030 See the full side effects section on this page, and ask your doctor or pharmacist about any side effect that bothers you.
- Is Sunscreen a prescription drug?
- No. Sunscreen is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Sunscreen?
- Yes. Other FDA-listed products with the same active ingredients include Avobenzone, Homosalate, Octisalate, Sport Sunscreen SPF 30, Sport Sunscreen SPF 50, Sport Sunscreen SPF 70.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 03/03/2026 · Label text is shown as published by the manufacturer. Not medical advice