Drugplain

Sunscreen SPF 30 30 mg/mL

avobenzone, homosalate, octisalate, octocrylene · LOTION · Broder Bros Prime Line

6 Recalls on Record
Plain English

Sunscreen SPF 30 is a lotion containing avobenzone, homosalate, octisalate, octocrylene at 30 mg/mL, taken topical. Manufactured by Broder Bros Prime Line.

Key Facts

Brand Name
Sunscreen SPF 30
Generic Name
avobenzone, homosalate, octisalate, octocrylene
NDC Code (Product)
71513-508
Manufacturer
Broder Bros Prime Line
Strength
30 mg/mL
Dosage Form
LOTION
Route
TOPICAL
Marketing Status
Application #
M020
Marketing Start
01/21/2021

Recall History

6 Recalls on Record
Class II08/18/2023

HUMANRACE

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

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 III12/10/2018

CBI Laboratories, Inc.

Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.

TerminatedVoluntary: Firm initiated
Class III08/03/2018

Product Quest Manufacturing LLC

Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.

TerminatedVoluntary: Firm initiated
Class II10/10/2025

CA BOTANA International, Inc.

CGMP Deviations

OngoingVoluntary: Firm initiated
Class II10/10/2025

CA BOTANA International, Inc.

CGMP Deviations

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective519 reports
macular degeneration453 reports
off label use324 reports
pyrexia306 reports
nausea294 reports
pain293 reports
malaise265 reports
weight decreased240 reports
therapeutic product effect incomplete216 reports
headache212 reports

Frequently Asked Questions

What is Sunscreen SPF 30 used for?

Sunscreen SPF 30 contains avobenzone, homosalate, octisalate, octocrylene. It is a lotion taken topical. Consult your doctor for specific uses.

Is Sunscreen SPF 30 a controlled substance?

Sunscreen SPF 30 is not classified as a controlled substance by the DEA.

What is the generic name for Sunscreen SPF 30?

The generic name for Sunscreen SPF 30 is avobenzone, homosalate, octisalate, octocrylene. There are 12 other brand versions of avobenzone, homosalate, octisalate, octocrylene.

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

The NDC (National Drug Code) for Sunscreen SPF 30 30 mg/mL is 71513-508, listed by Broder Bros Prime Line.