FDA.reportPublic FDA data

DERMATONE SPF50 C-SPRAY 5oz IS0335-DT

Manufacturer
Dermatone Labs LLC | Inspec Solutions
Effective date
2026-05-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:56:52

Label at a glance#

ProductDERMATONE SPF50 Sunscreen
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE
Label structure10 sections

Indications and uses

•helps prevent sunburn•

Dosage and administration

• 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 i...

Label contents#

Full prescribing information#

Active ingredients                  Purpose

OTC - ACTIVE INGREDIENT SECTION

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

Uses

INDICATIONS & USAGE SECTION

•helps prevent sunburn•

Warnings For external use only. Flammable:

WARNINGS SECTION

Do not use near heat, flame or while smoking.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product 

OTC - WHEN USING SECTION

• 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 

OTC - STOP USE SECTION

rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

INACTIVE INGREDIENT SECTION

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

Mineral Oil

Tetrahexyldecyl Ascorbate

Tocopheryl Acetate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54414-028-05DERMATONE SPF50 Sunscreen141 g in 1 CANSPRAY1412

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54414-02854414-028-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
FRAGRANCE VERBENA JUNIPERBERRY ORC1403606A59PZZ5O26IACT
ORYZA SATIVA (RICE) BRANR60QEP13ICIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
ALCOHOL3K9958V90MIACT
ALOEV5VD430YW9IACT
MINERAL OILT5L8T28FGPIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DERMATONE SPF50 SunscreenAVABENZONE 3% HOMOSALATE 10% OCTISALATE 5%Dermatone Labs LLC4dc81593-4790-403f-9d49-6569bcd0fea22026-05-11WarningsExact identifier
ndc (package): 54414-028-05
ndc (product): 54414-028
ndc11 (package): 54414002805
spl id: 518d22d6-884f-7c55-e063-6294a90a63a8
spl set id: 4dc81593-4790-403f-9d49-6569bcd0fea2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.