Drugplain

Sunscreen SPF 50 3 g/100g

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

6 Recalls on Record
Plain English

Sunscreen SPF 50 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 50
Generic Name
Avobenzone 3% , Homosalate 10%,Octisalate 5%
NDC Code (Product)
49757-010
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 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
Class II10/10/2025

CA BOTANA International, Inc.

CGMP Deviations

OngoingVoluntary: Firm initiated
Class II08/22/2025

GRACE & FIRE PTY LTD

Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.

OngoingVoluntary: 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 use322 reports
pyrexia306 reports
pain291 reports
nausea288 reports
malaise264 reports
weight decreased238 reports
therapeutic product effect incomplete215 reports
headache209 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

Drug Facts

Warnings

Warnings For external use only Do not use on broken or damaged 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 swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Sunscreen SPF 50 used for?

Sunscreen SPF 50 contains Avobenzone 3% , Homosalate 10%,Octisalate 5%. It is a spray taken topical. Consult your doctor for specific uses.

Is Sunscreen SPF 50 a controlled substance?

Sunscreen SPF 50 is not classified as a controlled substance by the DEA.

What is the generic name for Sunscreen SPF 50?

The generic name for Sunscreen SPF 50 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 50 3 g/100g?

The NDC (National Drug Code) for Sunscreen SPF 50 3 g/100g is 49757-010, listed by Rocky Mountain.

Product NDC

49757-010

Package NDC

49757-010-09

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

Data from openFDA · Public domain (CC0 1.0)