FDA.reportPublic FDA data

Degil Sun SPF 50 Sunscreen

Manufacturer
Degil Safety Products (1989) Inc | HK Kolmar Canada
Effective date
2024-04-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:11:49

Label at a glance#

ProductDegil Sun SPF 50 Sunscreen
Active ingredientOCTISALATE, AVOBENZONE, OXYBENZONE, OCTOCRYLENE, HOMOSALATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Homosalate 13%

Octisalate 5%

Oxybenzone 4%

Avobenzone 3%

Octocrylene 7%

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

Sun Protection Factor 50 • SPF 50 • Helps prevent sunburn • Sunburn protectant

• Helps protect from sunburn • If used as directed with other sun protection measures [see Directions (for Use)], decreases the risk of skin cancer and early skin aging caused by the sun • Water Resistant (80 minutes)

WARNINGS SECTION

For external use only

Do not use on broken skin

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water

Stop use and ask a doctor if rash occurs

If swallowed, call a poison control centre or get medical help right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INSTRUCTIONS FOR USE SECTION

Adults and children over 6 months of age • Apply liberally/generously (and evenly) 15 minutes before sun exposure • Reapply 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 value of 15 or higher and other sun protection measures including: ▪ limit time in the sun, especially from 11 a.m. – 3 p.m.; and ▪ wear long-sleeved shirts, pants, hats and sunglasses • Reapply after 80 minutes of swimming or sweating • Reapply immediately after towel drying

INACTIVE INGREDIENT SECTION

Aqua, Sorbitol, Aluminium Starch Octenylsuccinate , VP / Eicosene Copolymer, Stearic acid, Triethanolamine, Sorbitan Isostearate, Benzyl Alcohol, Dimethicone, Palmitic acid, Polyglyceryl-3 Distearate, Carbomer, Methylparaben, Propylparaben, Vitamin E, Disodium EDTA

USER SAFETY WARNINGS SECTION

Other information

Protect the product from excessive heat and direct sun

Questions? 1-800-332-1810 / sales@delta-plus.ca

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DEGIL Sun 50 SPF FPS

SUNSCREEN

Broad Spectrum
UVA & UBV Protection

Protection UVA & UVB

Dermatologist Tested. Moisturizing Aloe &
Vitamin E. Unscented Lotion.
Water Resistant (80 minutes).

DIN 02543443

120 mL(4 fl.oz.)/750 mL(25 fl.oz.)

Distributed by
Degil Safety Products (1989) Inc.
Vaughan,ontario,Canada L4H 0L6
MADE IN CANADA labellabel

DOSAGE & ADMINISTRATION SECTION

Lotion

Topical

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
58331-075-01Degil Sun SPF 50 Sunscreen120 mL in 1 BOTTLELOTION1201
58331-075-03Degil Sun SPF 50 Sunscreen750 mL in 1 BOTTLELOTION7501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58331-075DEGIL SUN SPF 50 SUNSCREEN (HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) LOTION [DEGIL SAFETY PRODUCTS (1989) INC]1Current NDC, 2 package rows20240501_155aa0c5-6403-ee86-e063-6294a90a1c4d.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58331-07558331-075-01, 58331-075-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTISALATE4X49Y0596WACTIB
METHYLPARABENA2I8C7HI9TIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
AVOBENZONEG63QQF2NOXACTIB
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
DIMETHICONE92RU3N3Y1OIACT
PALMITIC ACID2V16EO95H1IACT
PROPYLPARABENZ8IX2SC1OHIACT
POLYGLYCERYL-3 DISTEARATEZI1LK470XVIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
SORBITOL506T60A25RIACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
BENZYL ALCOHOLLKG8494WBHIACT
STEARIC ACID4ELV7Z65APIACT
EDETATE DISODIUM7FLD91C86KIACT
OXYBENZONE95OOS7VE0YACTIB
WATER059QF0KO0RIACT
OCTOCRYLENE5A68WGF6WMACTIB
HOMOSALATEV06SV4M95SACTIB
TROLAMINE9O3K93S3TKIACT

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
Degil Sun SPF 50 SunscreenHOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENEDegil Safety Products (1989) Inc155aa0c5-6403-ee86-e063-6294a90a1c4d2024-04-05WarningsExact identifier
ndc (package): 58331-075-01
ndc (package): 58331-075-03
ndc (product): 58331-075
ndc11 (package): 58331007501
ndc11 (package): 58331007503
spl id: 155aa0c5-6404-ee86-e063-6294a90a1c4d
spl set id: 155aa0c5-6403-ee86-e063-6294a90a1c4d

Reported adverse events (FAERS/openFDA)#

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