DEGIL SUN SPF 50 SUNSCREEN- homosalate, octisalate, oxybenzone, avobenzone, octocrylene lotion

Degil Sun SPF 50 Sunscreen by

Drug Labeling and Warnings

Degil Sun SPF 50 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Degil Safety Products (1989) Inc, HK Kolmar Canada. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Homosalate 13%

Octisalate 5%

Oxybenzone 4%

Avobenzone 3%

Octocrylene 7%

PURPOSE

Sunscreen

INDICATIONS & USAGE

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

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INSTRUCTIONS FOR USE

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

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

Other information

Protect the product from excessive heat and direct sun

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

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

Lotion

Topical

INGREDIENTS AND APPEARANCE

DEGIL SUN SPF 50 SUNSCREEN 
homosalate, octisalate, oxybenzone, avobenzone, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58331-075
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PALMITIC ACID (UNII: 2V16EO95H1)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
SORBITOL (UNII: 506T60A25R)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
BENZYL ALCOHOL (UNII: LKG8494WBH)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58331-075-01	120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package	05/06/2024
2	NDC: 58331-075-03	750 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package	05/06/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/01/2024

Labeler - Degil Safety Products (1989) Inc (247083686)

Establishment
Name	Address	ID/FEI	Business Operations
HK Kolmar Canada		243501959	manufacture(58331-075)