PRO-SIL SPF- silicone stick with spf stick

Pro-Sil SPF by

Drug Labeling and Warnings

Pro-Sil SPF by is a Otc medication manufactured, distributed, or labeled by Biodermis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION:

PROSIL SPF15

SILICONE STICK FOR SCARS

GLIDE-ON THERAPY FOR YOUR SCARS

ACTIVE INGREDIENTS:

Avobenzone - 3% Sunscreen

Octocrylene - 5% Sunscreen agent

Octinoxate - 4% Sunscreen agent

DOSAGE & ADMINISTRATION:

Apply 15 minutes before sun exposure. Clean and dry scar site before each application. Apply Pro-Sil® liberally over the entire
scar. May be covered with a bandage. Repeat several times daily for 8–12 weeks or until scar stops responding. To remove, wipe off with a clean cloth or tissue.

PURPOSE:

SILICONE STICK FOR SCARS

BROAD SPECTRUM UVA/UVB SUNSCREEN

HELPS PREVENT SUNBURN

INDICATIONS & USAGE:

SILICONE STICK FOR SCARS

BROAD SPECTRUM UVA/UVB SUNSCREEN

HELPS PREVENT SUNBURN

DIRECTIONS:

Apply 15 minutes before sun exposure. Clean and dry scar site
before each application. Apply Pro-Sil® liberally over the entire scar. May be
covered with a bandage. Repeat several times daily for 8–12 weeks or until
scar stops responding. To remove, wipe off with a clean cloth or tissue. Store
between 55°F–95°F (13°C–35°C).

WARNINGS:

FOR EXTERNAL USE ONLY

WARNINGS AND PRECAUTIONS:

EXTERNAL USE ONLY

CAUTIONS: Stop use and ask a doctor if rash occurs. Do not use on
damaged or broken skin. For children under 5 year of age, use under
adult supervision. Children under 6 months of age: Ask a doctor.

CAUTIONS:

Stop use and ask a doctor if rash occurs. Do not use on damaged
or broken skin. For children under 5 year of age, use under adult supervision.
Children under 6 months of age: Ask a doctor.

KEEP OUT OF REACH OF CHILDREN:

KEEP OUT OF REACH OF CHILDREN:

ASK A DOCTOR:

Ask a doctor about using PROSIL SPF with children under 6 months old.

STORAGE:

Store between 55°F–95°F (13°C–35°C).

CONTACT INFORMATION:

MADE IN THE USA U.S. Patent No. 8,557,287

BIODERMIS LLC
1820 Whitney Mesa Drive, Suite 100

Henderson, Nevada 89014 USA

800.322.3729 (USA) 702.260.4466 (INTL)

www.biodermis.com

INACTIVE INGREDIENTS:

Silicone

Primary Package Label

4.25g Tube:

17g Tube:

1g Sample Tube:

INGREDIENTS AND APPEARANCE

PRO-SIL SPF 
silicone stick with spf stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84440-608
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	40 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SILICON (UNII: Z4152N8IUI)	880 mg  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84440-608-01	1 g in 1 TUBE; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug	08/08/2025
2	NDC: 84440-608-42	4.25 g in 1 TUBE; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug	08/08/2025
3	NDC: 84440-608-17	17 g in 1 TUBE; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug	08/08/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/08/2025

Labeler - Biodermis, LLC (809650005)