Drugplain

Sunscreen 30 mg/mL

Avobenzone, Homosalate, Octisalate, Octocrylene · LOTION · American Sales Company

10 Recalls on Record
Plain English

Sunscreen containing avobenzone, homosalate, octisalate, and octocrylene is a topical lotion applied to the skin to protect against ultraviolet (UV) rays from the sun. This over-the-counter product helps prevent sunburn and reduces the risk of skin cancer and premature skin aging.

Key Facts

Brand Name
Sunscreen
Generic Name
Avobenzone, Homosalate, Octisalate, Octocrylene
NDC Code (Product)
41520-769
Manufacturer
American Sales Company
Strength
30 mg/mL
Dosage Form
LOTION
Route
TOPICAL
Marketing Status
Application #
M020
Marketing Start
01/12/2016

Recall History

10 Recalls on Record
Class II03/12/2025

KABANA SKIN CARE

cGMP deviations

OngoingVoluntary: Firm initiated
Class II07/14/2021

Johnson & Johnson Consumer, Inc.

cGMP Deviations

OngoingVoluntary: Firm initiated
Class II08/18/2023

HUMANRACE

Subpotent Drug: Product does not contain SPF that is declared on the label.

OngoingVoluntary: Firm initiated
Class II09/24/2013

W.S. Badger Company Inc.

Microbial Contamination of Non-Sterile Products; Selected lots of Badger Baby and Kids Sunscreen Lotion were recalled due to microbial contamination.

TerminatedVoluntary: Firm initiated
Class I09/30/2021

Beiersdorf Inc

Chemical contamination; presence of benzene

TerminatedVoluntary: Firm initiated
Class II08/18/2023

HUMANRACE

Subpotent Drug: Product does not contain SPF that is declared on the label.

OngoingVoluntary: Firm initiated
Class II10/10/2025

CA BOTANA International, Inc.

CGMP Deviations

OngoingVoluntary: Firm initiated
Class II07/14/2021

Johnson & Johnson Consumer, Inc.

cGMP Deviations

OngoingVoluntary: Firm initiated
Class II03/12/2025

KABANA SKIN CARE

cGMP deviations

OngoingVoluntary: Firm initiated
Class II07/14/2021

Johnson & Johnson Consumer, Inc.

cGMP Deviations

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective559 reports
macular degeneration453 reports
off label use334 reports
pain314 reports
pyrexia310 reports
nausea307 reports
malaise274 reports
weight decreased248 reports
headache227 reports
therapeutic product effect incomplete218 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 apply liberally 15 minutes before sun exposure reapply at least every 2 hours use 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 sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses children under 6 months: ask a doctor

Warnings

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

Frequently Asked Questions

What is Sunscreen used for?

Sunscreen containing avobenzone, homosalate, octisalate, and octocrylene is a topical lotion applied to the skin to protect against ultraviolet (UV) rays from the sun. This over-the-counter product helps prevent sunburn and reduces the risk of skin cancer and premature skin aging.

Is Sunscreen a controlled substance?

Sunscreen is not classified as a controlled substance by the DEA.

What is the generic name for Sunscreen?

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

What is the NDC code for Sunscreen 30 mg/mL?

The NDC (National Drug Code) for Sunscreen 30 mg/mL is 41520-769, listed by American Sales Company.