DERMATONE SPF50 SUNSCREEN- avabenzone 3% homosalate 10% octisalate 5% spray

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredients                  Purpose

Avobenzone 3.00%                   Sunscreen
Homosalate 10.00%                  Sunscreen
Octisalate 5.00%.                      Sunscreen

PURPOSE

Uses

helps prevent sunburn

Warnings For external use only. Flammable:

Do not use near heat, flame or while smoking.

Do not use

on damaged or broken skin.

When using this product 

keep out of eyes. Rinse with water to remove. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120ºF.

Stop use and ask doctor if 

rash occurs.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately

Directions

spray liberally and spread evenly by hand 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours

hold container 4 to 6 inches from the skin to apply
do not spray directly into face. Spray on hands then apply to face
do not apply in windy conditions use in a well-ventilated area
Sun Protection Measures. Spending tme 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 of 15 or higher and other sun protection measures including:

limit time in the sun, especially from
10 a.m. - 2. p.m. wear a long-sleeve shirt, pants, hats, and sunglasses.
children under 6 months: Ask a doctor.

Inactive Ingredeints

Alcohol Denat.
Butyloctyl Salicylate
Fragrance
Oryza Sativa (Rice) Bran Oil
Polyester-8
VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Mineral Oil

Tetrahexyldecyl Ascorbate

Tocopheryl Acetate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMATONE SPF50 SUNSCREEN 
avabenzone 3% homosalate 10% octisalate 5% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54414-028
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FRAGRANCE VERBENA JUNIPERBERRY ORC1403606 (UNII: A59PZZ5O26)
ORYZA SATIVA (RICE) BRAN (UNII: R60QEP13IC)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
ALCOHOL (UNII: 3K9958V90M)
ALOE (UNII: V5VD430YW9)
MINERAL OIL (UNII: T5L8T28FGP)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54414-028-05	141 g in 1 CAN; Type 0: Not a Combination Product	08/06/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/06/2025

Labeler - Dermatone Labs LLC (100928460)

Registrant - Inspec Solutions (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions		081030372	manufacture(54414-028)