CROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE- homosalate, octisalate, octocrylene, oxybenzone, and avobenzone lotion

CROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE by

Drug Labeling and Warnings

CROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE by is a Otc medication manufactured, distributed, or labeled by Degil Safety Products (1989) Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Homosalate 13.0% w/w

Octocylene 7.0% w/w

Octisalate 5.0% w/w

Oxybenzone 4.0% w/w

Avobenzome 3.0% w/w

Purpose

• Sunscreen

Uses

• Helps prevent sunburn

Warnings

For external use only

DO NOT USE

Do not use on damaged or broken skin

Keep out of reach of children

• May stain or damage some fabrics or surfaces

When using this product

• Avoid contact with eyes. Rinse with water to remove.

Stop use and ask doctor if

• Rash or irritation develops and lasts

Directions

• Apply liberally and evenly to dry skin 15 minutes before exposure to the sun. Reapply every 2 hours to insure adequate UV protection or 80 minutes after swimming, perspiring heavily, or immediately after washing and towel drying.
• For children under 6 months of age: Ask a doctor

Other Information

• Protect the product from excessive heat and direct sun

Inactive Ingredients

Aqua, Sorbitol, Aluminum Starch Octenylsuccinate VP/Eicosene Copolymer, Stearic Acid, Triethanolamine, Sorbitan Isostearate, Benzyl Alcohol, Dimethicone, Tocopherol, Polyglyceryl-3 Distearate, Methylparaben, Carbomer, Propylparaben, Disodium EDTA.

PRINCIPAL DISPLAY PANEL

UVA / UVB PROTECTION

CONTRE LES RAYONS UVA ET UVB

Dermatologist Tested Gentle Lotion formula

Unscented Water Resistant (80 Minutes)

Testé par les dermatologues Formule écran solaire

Douce Non Parfumée Résistant à I'eau

Sunscreen

SPF 50 FPS

Écran Solaire

Distributed by/Distribué par:

Croc Bloc Products Inc.

200 Zenway Blvd., Unit 1 Vaughan, Ontario, Canada

1-800-332-1810

Email: degil@degilsafety.com

Website: www.degilsafety.com

INGREDIENTS AND APPEARANCE

CROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE 
homosalate, octisalate, octocrylene, oxybenzone, and avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58331-050
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
BENZYL ALCOHOL (UNII: LKG8494WBH)
DIMETHICONE (UNII: 92RU3N3Y1O)
TOCOPHEROL (UNII: R0ZB2556P8)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SORBITOL (UNII: 506T60A25R)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58331-050-01	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/18/2020
2	NDC: 58331-050-03	750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/18/2020
3	NDC: 58331-050-02	10 mL in 1 PACKET; Type 0: Not a Combination Product	02/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/18/2020

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