FDA.reportPublic FDA data

Dermatone Sport SPF 50 Sunscreen Lotion

Manufacturer
Dermatone Labs LLC | Inspec Solutions LLC | Inspec Solutions LLC.
Effective date
2025-12-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:28:13

Label at a glance#

ProductDermatone Sport SPF 50
Active ingredientAVOBENZONE, HOMOSALATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Avobenzone 3.0%

Homosalate 10.0%

Octocrylene 6.0%

INDICATIONS & USAGE SECTION

Uses

• Helps prevent sunburn, higher SPF gives more sunburn protection

WARNINGS SECTION

WARNINGS

For external use only.

When using this product:

• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor ifrash occurs.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

INACTIVE INGREDIENT SECTION

Aluminum Starch Octenylsuccinate
Benzyl Alcohol
Butyloctyl Salicylate
Carbomer
D-Glucitol
Dimethicone
Disodium EDTA
Ethylhexylglycerin
Fragrance
Phenoxyethanol
Polyglyceryl-3-Distearate
Sorbitan Isostearate
Stearic Acid
Triethanolamine
VP/Eicosene Copolymer
Water

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS

• Apply liberally 15 minutes before sun exposure.

• Reapply:

after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours

٠For sunscreen use
٠apply to all areas of the skin exposed to the sun.
٠Reapply as needed or after towel drying, swimming, or sweating.

OTC - PURPOSE SECTION

Sunscreen

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54414-027-11Dermatone Sport SPF 503784 mL in 1 CONTAINERLOTION37842

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54414-02754414-027-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTOCRYLENE5A68WGF6WMIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
BENZYL ALCOHOLLKG8494WBHIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CARBOMER0A5MM307FCIACT
SORBITOL506T60A25RIACT
DIMETHICONE92RU3N3Y1OIACT
EDETATE DISODIUM7FLD91C86KIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
FRAGRANCE CLEAN ORC0600327329LCV5BTFIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYGLYCERYL-3 DISTEARATEZI1LK470XVIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
STEARIC ACID4ELV7Z65APIACT
TRIETHANOLAMINE9O3K93S3TKIACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
WATER059QF0KO0RIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB

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 Sport SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6%Dermatone Labs LLC0e60e5bb-b941-4114-933a-29480bff59602025-12-24WarningsExact identifier
ndc (package): 54414-027-11
ndc (product): 54414-027
ndc11 (package): 54414002711
spl id: 46b5b1f6-2248-d0d7-e063-6294a90a335f
spl set id: 0e60e5bb-b941-4114-933a-29480bff5960

Reported adverse events (FAERS/openFDA)#

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