Drugplain

Avobenzone, Homosalate, Octisalate 30 mg/mL

Avobenzone, Homosalate, Octisalate · LOTION · Old East Main Co.

2 Recalls on Record
Plain English

This is a sunscreen lotion applied to the skin that contains three active ingredients—avobenzone, homosalate, and octisalate—which work together to protect against ultraviolet (UV) rays from the sun. It is available without a prescription and helps prevent sunburn when applied to exposed skin.

Key Facts

Brand Name
Avobenzone, Homosalate, Octisalate
Generic Name
Avobenzone, Homosalate, Octisalate
NDC Code (Product)
75712-935
Manufacturer
Old East Main Co.
Strength
30 mg/mL
Dosage Form
LOTION
Route
TOPICAL
Marketing Status
Application #
M020
Marketing Start
08/01/2023

Recall History

2 Recalls on Record
Class II03/19/2020

Filltech USA, LLC

Microbial contamination of non-sterile products: positive test for yeast and bacteria.

TerminatedVoluntary: Firm initiated
Class II03/19/2020

Filltech USA, LLC

Microbial contamination of non-sterile products: positive test for yeast and bacteria.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

rash13 reports
acne10 reports
erythema9 reports
sunburn9 reports
dry skin8 reports
malignant melanoma8 reports
application site erythema7 reports
headache7 reports
off label use7 reports
pain6 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

Directions spray liberally and spread evenly by hand 15 minutes before sun exposure apply to all skin exposed to the sun hold container 4 to 6 inches from the skin to apply do not spray directly into face. Spray on hands then apply to face. do not apply in windy conditions use in a well-ventilated area and avoid inhalation 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 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

Warnings

Warnings For external use only

Adverse Reactions

Adverse Reaction DSP-TN-21091 DSP-MO-20087 DISTRIBUTED BY OLD EAST MAIN CO. 100 MISSION RIDGE GOODLETSVILLE, TN 37072 100% Satisfaction Guaranteed! (888) 309-9030

Frequently Asked Questions

What is Avobenzone, Homosalate, Octisalate used for?

This is a sunscreen lotion applied to the skin that contains three active ingredients—avobenzone, homosalate, and octisalate—which work together to protect against ultraviolet (UV) rays from the sun. It is available without a prescription and helps prevent sunburn when applied to exposed skin.

Is Avobenzone, Homosalate, Octisalate a controlled substance?

Avobenzone, Homosalate, Octisalate is not classified as a controlled substance by the DEA.

What is the generic name for Avobenzone, Homosalate, Octisalate?

The generic name for Avobenzone, Homosalate, Octisalate is Avobenzone, Homosalate, Octisalate. There are 12 other brand versions of Avobenzone, Homosalate, Octisalate.

What is the NDC code for Avobenzone, Homosalate, Octisalate 30 mg/mL?

The NDC (National Drug Code) for Avobenzone, Homosalate, Octisalate 30 mg/mL is 75712-935, listed by Old East Main Co..