Drugplain

Broad Spectrum Sunscreen SPF 30 30 mg/g

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

2 Recalls on Record
Plain English

This is a topical sunscreen spray containing multiple active ingredients that work together to protect your skin from ultraviolet (UV) rays. It should be applied to exposed skin before going outside to help prevent sunburn and reduce the risk of skin cancer.

Key Facts

Brand Name
Broad Spectrum Sunscreen SPF 30
Generic Name
Avobenzone, Homosalate, Octisalate
NDC Code (Product)
75712-948
Manufacturer
Old East Main Co.
Strength
30 mg/g
Dosage Form
SPRAY
Route
TOPICAL
Marketing Status
Application #
M020
Marketing Start
07/15/2024

Recall History

2 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

Side Effects Reported to FDA

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

drug ineffective506 reports
macular degeneration453 reports
off label use313 reports
pyrexia303 reports
nausea284 reports
pain280 reports
malaise259 reports
weight decreased235 reports
therapeutic product effect incomplete213 reports
headache201 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use helps prevent sunburn

Dosage & Administration

Directions 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

Warnings

Warnings Do not use on damaged or broken skin When using this product, keep out of eyes Stop use and ask a doctor if rash occurs Keep out of reach of children.

Frequently Asked Questions

What is Broad Spectrum Sunscreen SPF 30 used for?

This is a topical sunscreen spray containing multiple active ingredients that work together to protect your skin from ultraviolet (UV) rays. It should be applied to exposed skin before going outside to help prevent sunburn and reduce the risk of skin cancer.

Is Broad Spectrum Sunscreen SPF 30 a controlled substance?

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

What is the generic name for Broad Spectrum Sunscreen SPF 30?

The generic name for Broad Spectrum Sunscreen SPF 30 is Avobenzone, Homosalate, Octisalate. There are 12 other brand versions of Avobenzone, Homosalate, Octisalate.

What is the NDC code for Broad Spectrum Sunscreen SPF 30 30 mg/g?

The NDC (National Drug Code) for Broad Spectrum Sunscreen SPF 30 30 mg/g is 75712-948, listed by Old East Main Co..

Product NDC

75712-948

Package NDC

75712-948-14

Other Avobenzone, Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)