FDA.reportPublic FDA data

Dermisa SUNSCREEN SPF 55

Manufacturer
Montani Cosmetics Inc
Effective date
2017-09-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:30

Label at a glance#

ProductDermisa SUNSCREEN SPF 55 BROAD SPECTRUM
Active ingredientOCTOCRYLENE, AVOBENZONE, OXYBENZONE, OCTISALATE, HOMOSALATE
Label structure11 sections

Indications and uses

helps prevent sunburn

Dosage and administration

• apply 15 minutes before sun exposure • reapply • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 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 sun, ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.00%

Homosalate 10.00%

Octisalate 5.00%

Octocrylene 2.75%

Oxybenzone 6.00%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Uses

INDICATIONS & USAGE SECTION

helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only

Do not use on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

• keep out of eyes • rinse with water to remove

Stop use and ask a doctor if

OTC - STOP USE SECTION

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 15 minutes before sun exposure • reapply • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 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 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

SPL UNCLASSIFIED SECTION

• protect this product from excessive heat and direct sun • might stain fabrics • store at room temperature

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Behenyl Alcohol, BHT, Butyloctyl Salicylate, Caprylyl Methicone, Dimethicone, Dimethyl Capramide, Disodium EDTA, Ethylhexyl Stearate, Ethylhexylglycerin, Ethylparaben, Fragrance, Glyceryl Stearate, Iodopropynyl Butylcarbamate, Methylparaben, PEG-100 Stearate, Phenoxyethanol, Polyester-8, Propylparaben, Silica, Sodium Polyacrylate, Styrene/Acrylates Copolymer, Trideceth-6, Trimethylsiloxysilicate, VP/Hexadecene Copolymer, Water, Xanthan Gum

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68343-003-042020-01-31C16284748780-19d75b9cf-dd69-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68343-003-04Dermisa SUNSCREEN SPF 55BROAD SPECTRUM118 mL in 1 TUBELOTION1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68343-003DERMISA SUNSCREEN SPF 55 BROAD SPECTRUM (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [MONTANI COSMETICS INC]1Legacy NDC, 1 package rows20170914_58ece525-b62a-fa51-e053-2991aa0a35ef.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68343-00368343-003-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
VINYLPYRROLIDONE/HEXADECENE COPOLYMERKFR5QEN0N9IACT
WATER059QF0KO0RIACT
TRIDECETH-63T5PCR2H0CIACT
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
OXYBENZONE95OOS7VE0YACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
DOCOSANOL9G1OE216XYIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
DIMETHICONE92RU3N3Y1OIACT
DIMETHYL CAPRAMIDEO29Y6X2JEZIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
OCTISALATE4X49Y0596WACTIB
HOMOSALATEV06SV4M95SACTIB
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ETHYLPARABEN14255EXE39IACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
METHYLPARABENA2I8C7HI9TIACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
PROPYLPARABENZ8IX2SC1OHIACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)5041RX63GNIACT
XANTHAN GUMTTV12P4NEEIACT

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
58ece525-b62b-fa51-e053-2991aa0a35ef58ece525-b62a-fa51-e053-2991aa0a35ef2017-09-11WarningsExact identifier
spl id: 58ece525-b62b-fa51-e053-2991aa0a35ef
spl set id: 58ece525-b62a-fa51-e053-2991aa0a35ef

Reported adverse events (FAERS/openFDA)#

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