Degil Sun Spf 50 Sunscreen

Degil Sun Spf 50 Sunscreen
SPL v1
SPL
SPL Set ID 155aa0c5-6403-ee86-e063-6294a90a1c4d
Route
TOPICAL
Published
Effective Date 2024-04-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (5 g) Avobenzone (3 g) Oxybenzone (4 g) Octocrylene (7 g) Homosalate (13 g)
Inactive Ingredients
Methylparaben .alpha.-tocopherol Aluminum Starch Octenylsuccinate Sorbitan Isostearate Dimethicone Palmitic Acid Propylparaben Polyglyceryl-3 Distearate Carbomer Homopolymer, Unspecified Type Sorbitol Vinylpyrrolidone/eicosene Copolymer Benzyl Alcohol Stearic Acid Edetate Disodium Water Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-01

Description

Homosalate 13% Octisalate 5% Oxybenzone 4% Avobenzone 3% Octocrylene 7%


Medication Information

Warnings and Precautions

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.

Indications and 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)

Dosage and Administration

Lotion

Topical

Description

Homosalate 13% Octisalate 5% Oxybenzone 4% Avobenzone 3% Octocrylene 7%

Section 50565-1

Keep out of reach of children

Section 51727-6

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

Section 51945-4

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

Section 54433-8

Other information

Protect the product from excessive heat and direct sun

Questions? 1-800-332-1810 / [email protected]

Section 55105-1

Sunscreen

Section 55106-9

Homosalate 13%

Octisalate 5%

Oxybenzone 4%

Avobenzone 3%

Octocrylene 7%

Section 59845-8

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


Structured Label Content

Indications and Usage (34067-9)

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)

Dosage and Administration (34068-7)

Lotion

Topical

Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

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

Section 54433-8 (54433-8)

Other information

Protect the product from excessive heat and direct sun

Questions? 1-800-332-1810 / [email protected]

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Homosalate 13%

Octisalate 5%

Oxybenzone 4%

Avobenzone 3%

Octocrylene 7%

Section 59845-8 (59845-8)

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


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