FDA.reportPublic FDA data

Degil Sun SPF 30 Sunscreen

Manufacturer
Degil Safety Products (1989) Inc | HK Kolmar Canada
Effective date
2024-04-24
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 30 Sunscreen
Active ingredientOXYBENZONE, OCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE
Label structure10 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Lotion

Topical

OTC - ACTIVE INGREDIENT SECTION

Homosalate 10.5%, Octisalate 5%, Oxybenzone 2%, Avobenzone 2%,
Octocrylene 2%

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

Sun Protection Factor 30 • SPF 30 • 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 (40 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

Keep out of reach of children. 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 40 minutes of swimming or sweating • Reapply immediately after towel drying

INACTIVE INGREDIENT SECTION

Aqua,Sorbitol, Sorbitan Isostearate, Polyglyceryl-3 Distearate, Barium Sulfate, Acrylates / Octylacrylamide Copolymer, Palmitic acid, Triethanolamine, Stearic acid, Benzyl Alcohol, VP/Eicosene Copolymer, Dimethicone, Carbomer, Methyl paraben, Aloe Barbadensis Leaf Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Vitamin E, Propylparaben, Disodium EDTA, Propylene glycol

OTHER SAFETY INFORMATION

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

labellabelDEGIL Sun SPF 30 Sunscreen

Broad Spectrum

UVA&UVB Protection

Dermatologist Tested. Moisutrizing Aloe & Vitamin E.

Unscented Lotion. Water Resistant (40 minutes)

DIN 02535785

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1Product name120201123
85bed648-23ca-4804-98e6-e36aee999cadProduct name120190717
80de93b4-8a94-428d-beb7-d644353ee70bProduct name120180424
eb4f7d5b-1286-40dc-b8bf-ad87ff51c688Product name120170522
db8eb201-78c7-4590-8a71-fac0a539bd8cProduct name120170404
141092be-5eb5-452e-9f69-2d350aa70a87Product name120161208
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
58331-060-01Degil Sun SPF 30 Sunscreen120 mL in 1 BOTTLELOTION1201
58331-060-02Degil Sun SPF 30 Sunscreen10 mL in 1 BOTTLELOTION101
58331-060-03Degil Sun SPF 30 Sunscreen30 mL in 1 BOTTLELOTION301
58331-060-04Degil Sun SPF 30 Sunscreen180 mL in 1 BOTTLELOTION1801
58331-060-05Degil Sun SPF 30 Sunscreen1000 mL in 1 BOTTLELOTION10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58331-060DEGIL SUN SPF 30 SUNSCREEN (HOMOSALATE, OCTISALATE, OXYBENZONE,AVOBENZONE, OCTOCRYLENE) LOTION [DEGIL SAFETY PRODUCTS (1989) INC]1Current NDC, 5 package rows20240501_16d8d1d0-e531-2a64-e063-6394a90a5b9c.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58331-06058331-060-01, 58331-060-02, 58331-060-03, 58331-060-04, 58331-060-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
OXYBENZONE95OOS7VE0YACTIB
PALMITIC ACID2V16EO95H1IACT
DIMETHICONE92RU3N3Y1OIACT
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
SORBITOL506T60A25RIACT
METHYLPARABENA2I8C7HI9TIACT
EDETATE DISODIUM7FLD91C86KIACT
ALOE VERA LEAFZY81Z83H0XIACT
HOMOSALATEV06SV4M95SACTIB
BARIUM SULFATE25BB7EKE2EIACT
ACRYLATES/OCTYLACRYLAMIDE COPOLYMER (40000 MW)7LL6SY9YFVIACT
TROLAMINE9O3K93S3TKIACT
PROPYLPARABENZ8IX2SC1OHIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
ALPHA-TOCOPHEROLH4N855PNZ1IACT
OCTOCRYLENE5A68WGF6WMACTIB
POLYGLYCERYL-3 DISTEARATEZI1LK470XVIACT
BENZYL ALCOHOLLKG8494WBHIACT
JOJOBA OIL724GKU717MIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
STEARIC ACID4ELV7Z65APIACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT

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 30 SunscreenHOMOSALATE, OCTISALATE, OXYBENZONE,AVOBENZONE, OCTOCRYLENEDegil Safety Products (1989) Inc16d8d1d0-e531-2a64-e063-6394a90a5b9c2024-04-24WarningsExact identifier
ndc (package): 58331-060-01
ndc (package): 58331-060-05
ndc (package): 58331-060-03
ndc (package): 58331-060-02
ndc (package): 58331-060-04
ndc (product): 58331-060
ndc11 (package): 58331006004
ndc11 (package): 58331006002
ndc11 (package): 58331006005
ndc11 (package): 58331006003
ndc11 (package): 58331006001
spl id: 16d8d1d0-e532-2a64-e063-6394a90a5b9c
spl set id: 16d8d1d0-e531-2a64-e063-6394a90a5b9c

Reported adverse events (FAERS/openFDA)#

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