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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Drug Facts

ActiveIngredientsPurposes
Homosalate13.0 % w/wSunscreen
Octocrylene  7.0 % w/wSunscreen
Octisalate  5.0 % w/wSunscreen
Oxybenzone  4.0 % w/wSunscreen
Avobenzone  3.0 % w/wSunscreen

Uses

  • Helps prevent sunburn

Warnings

For external use only.

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 - 120 mL Bottle Label

BROAD SPECTRUM

UVA / UVB PROTECTION

Dermatologist Tested • Gentle Formula • Unscented
Water Resistant (80 Minutes)

Net Contents : 4 fl. oz. (120 mL)
DIN 02401436

Sunscreen

SPF 50

Distributed by:
Croc Bloc Products Inc.
200 Zenway Blvd., Unit 1 Vaughan, Ontario, Canada
1-800-332-1810
E-mail: degil@degilsafety.com
Website: www.degilsafety.com

Principal Display Panel - 120 mL Bottle Label
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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (HOMOSALATE) HOMOSALATE13 g  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE5 g  in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE7 g  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE4 g  in 100 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
ALUMINUM STARCH OCTENYLSUCCINATE 
STEARIC ACID 
TROLAMINE 
SORBITAN ISOSTEARATE 
POLYGLYCERYL-3 DISTEARATE 
BENZYL ALCOHOL 
DIMETHICONE 1000 
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
METHYLPARABEN 
.ALPHA.-TOCOPHEROL 
PROPYLPARABEN 
EDETATE DISODIUM 
Packaging
#Item CodePackage Description
1NDC:58331-050-01120 mL in 1 BOTTLE, PLASTIC
2NDC:58331-050-0210 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/15/2013
Labeler - Degil Safety Products (1989) Inc. (247083686)
Registrant - Norwood Packaging Ltd. (243693926)

Revised: 04/2013
Document Id: ccad2fa1-ede5-4d12-a2c5-97b276f21f43
Set id: 59999fef-259d-4077-8ebb-e884541973a0
Version: 1
Effective Time: 20130430
 
Degil Safety Products (1989) Inc.