FDA.reportPublic FDA data

Dermatone Sunscreen SPF 30

Manufacturer
Beaumont Products | Product Quest Mfg
Effective date
2018-06-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:55:50

Label at a glance#

ProductDermatone Sunscreen SPF 30
Active ingredientAvobenzone, Homosalate, Octisalate, Octocrylene
Label structure9 sections

Indications and uses

Uses • helps prevent sunburn • if used as directed with other sun protection mesures (see Direction) decreases the risk of skin cancer

Dosage and administration

apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least 2 hours Sun Protection Measures. Spending time 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, especi...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Avobenzone - 3.00%
Homosalate - 10.00%
Octisalate - 5.00%
Octocrylene - 10.00%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Uses • helps prevent sunburn • if used as directed with other sun protection mesures (see Direction) decreases the risk of skin cancer

WarningFor external use only

WARNINGS SECTION

do not use on damaged or broken 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

apply liberally 15 minutes before sun exposure
reapply:
after 80 minutes of swimming or sweating
immediately after towel drying
at least 2 hours
Sun Protection Measures. Spending time 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 long-sleeve shirts, pants, hats, and sunglasses
children under 6 months: Ask a doctor

Other Information

OTHER SAFETY INFORMATION

protect this product from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

Inactive Ingredients:
Acrylates/C10-30 Alkyl Acrylate Crosspolymer
Benzyl Alcohol
Caprylic/Capric Triglyceride
Chlorphenesin
Diethylhexyl Syringylidenemalonate
Disodium EDTA
Ethylhexyl Palmitate
Oleth-3
Polyamide-8
Sodium Ascorbyl Phosphate
Sorbitol
Tocopherol
Triethanolamine
Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65449-001-012020-01-31C16284748780-19d75b9cf-fabb-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65449-001-01Dermatone Sunscreen SPF 3030 mL in 1 TUBELOTION301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65449-001DERMATONE SUNSCREEN SPF 30 (AVOBENZONE 3.00% HOMOSALATE 10.00% OCTISALATE 5.00% OCTOCRYLENE 10.00%) LOTION [BEAUMONT PRODUCTS]1Legacy NDC, 1 package rows20180608_e3760253-ce9a-49bd-b646-03e443c514df.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65449-00165449-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
AvobenzoneG63QQF2NOXACTIB
HomosalateV06SV4M95SACTIB
Octisalate4X49Y0596WACTIB
Octocrylene5A68WGF6WMACTIB
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
Benzyl AlcoholLKG8494WBHIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ChlorphenesinI670DAL4SZIACT
Diethylhexyl Syringylidenemalonate3V5U97P248IACT
EDETATE DISODIUM7FLD91C86KIACT
Ethylhexyl Palmitate2865993309IACT
Oleth-3BQZ26235UCIACT
Sodium Ascorbyl Phosphate836SJG51DRIACT
Sorbitol506T60A25RIACT
TocopherolR0ZB2556P8IACT
TROLAMINE9O3K93S3TKIACT
Water059QF0KO0RIACT

Source Document#

Source XML · Source PDF

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
6a6ab2d6-6dc3-4d78-8d0e-99f5e5668c7de3760253-ce9a-49bd-b646-03e443c514df2018-06-08WarningsExact identifier
spl id: 6a6ab2d6-6dc3-4d78-8d0e-99f5e5668c7d
spl set id: e3760253-ce9a-49bd-b646-03e443c514df

Reported adverse events (FAERS/openFDA)#

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