CROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE- homosalate, octisalate, octocrylene, oxybenzone, and avobenzone lotion 
Degil Safety Products (1989) Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

Uses

Warnings

For external use only

Do not use on damaged or broken skin

Keep out of reach of children

When using this product

Stop use and ask doctor if

Directions

Other Information

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 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

CROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE 
homosalate, octisalate, octocrylene, oxybenzone, and avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58331-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE13 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
TROLAMINE (UNII: 9O3K93S3TK)  
SORBITOL (UNII: 506T60A25R)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58331-050-01120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/21/2022
2NDC:58331-050-03750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/21/2022
3NDC:58331-050-0210 mL in 1 PACKET; Type 0: Not a Combination Product11/21/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/18/2020
Labeler - Degil Safety Products (1989) Inc. (247083686)

Revised: 11/2022
Document Id: ee029008-bcc8-4619-e053-2a95a90a399a
Set id: 59999fef-259d-4077-8ebb-e884541973a0
Version: 5
Effective Time: 20221121
 
Degil Safety Products (1989) Inc.