Drugplain

Sunscreen SPF 30 30 mg/g

Avobenzone, Homosalate, Octisalate, Octocrylene · SPRAY · Nice-Pak Products, LLC

6 Recalls on Record
Plain English

Sunscreen SPF 30 is a spray containing avobenzone, homosalate, octisalate, octocrylene at 30 mg/g, taken topical. Manufactured by Nice-Pak Products, LLC.

Key Facts

Brand Name
Sunscreen SPF 30
Generic Name
Avobenzone, Homosalate, Octisalate, Octocrylene
NDC Code (Product)
11344-109
Manufacturer
Nice-Pak Products, LLC
Strength
30 mg/g
Dosage Form
SPRAY
Route
TOPICAL
Marketing Status
Application #
M020
Marketing Start
03/01/2024

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

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 after 80 minutes of swimming or sweating, immediately after towel drying, at least every two 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 10am – 2pm wear long-sleeve 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 swallowed get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Sunscreen SPF 30 used for?

Sunscreen SPF 30 contains Avobenzone, Homosalate, Octisalate, Octocrylene. It is a spray 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/g?

The NDC (National Drug Code) for Sunscreen SPF 30 30 mg/g is 11344-109, listed by Nice-Pak Products, LLC.