Drugplain

Sunscreen SPF 30 3 g/100g

Avobenzone 3% , Homosalate 10%,Octisalate 5% · SPRAY · Rocky Mountain

6 Recalls on Record
Plain English

Sunscreen SPF 30 is a spray containing avobenzone 3% , homosalate 10%,octisalate 5% at 3 g/100g, taken topical. Manufactured by Rocky Mountain.

Key Facts

Brand Name
Sunscreen SPF 30
Generic Name
Avobenzone 3% , Homosalate 10%,Octisalate 5%
NDC Code (Product)
49757-012
Manufacturer
Rocky Mountain
Strength
3 g/100g
Dosage Form
SPRAY
Route
TOPICAL
Marketing Status
Application #
M20
Marketing Start
08/21/2025

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 3% , Homosalate 10%,Octisalate 5%. 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 3% , Homosalate 10%,Octisalate 5%. There are 2 other brand versions of Avobenzone 3% , Homosalate 10%,Octisalate 5%.

What is the NDC code for Sunscreen SPF 30 3 g/100g?

The NDC (National Drug Code) for Sunscreen SPF 30 3 g/100g is 49757-012, listed by Rocky Mountain.

Product NDC

49757-012

Package NDC

49757-012-06

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

Data from openFDA · Public domain (CC0 1.0)