CROC BLOC BROAD SPECTRUM SPF 30 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

Active IngredientsPurposes
Homosalate10.5%Sunscreen
Octisalate5.0%Sunscreen
Oxybenzone2.0%Sunscreen
Avobenzone2.0%Sunscreen
Octocrylene2.0%Sunscreen

Warnings

For external use only

  • Discontinue use if skin irritation develops or increases
  • If irritation persists, consult a health care practitioner

  • Avoid contact with eyes
  • If contact occurs, rinse thoroughly with water

  • Consult a healthcare practitioner prior to use on children less than six months of age

  • May stain or damage some fabrics or surfaces

  • Keep out of reach of children

Directions

Shake well. Apply generously 15-30 minutes prior to exposure to the sun. Reapply as needed or after swimming, towel drying, perspiring heavily, washing and vigorous activity.

Other Ingredients

Aqua, Sorbitan Isostearate, Sorbitol, Triethanolamine, Polyglyceryl-3 Distearate, Stearic Acid, Octadecene/MA Copolymer, Barium Sulfate, Benzyl Alcohol, VP/Eicosene Copolymer, Dimethicone, Carbomer, Methyl-paraben, Aloe Barbadensis Leaf Extract, Simmondsia Chinesis (Jojoba) Seed Oil, Tocopherol, Propylparaben, Disodium EDTA

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label

Sunscreen

SPF 30 FPS

BROAD SPECTRUM • LARGE SPECTRE
UVA/UVB PROTECTION

Unscented • Water & Sweat Resistant
Dermatologist Tested • Moisturizing Aloe & Vitamin E

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

Principal Display Panel - 120 mL Bottle Label
CROC BLOC BROAD SPECTRUM SPF 30 FPS ECRAN SOLAIRE 
homosalate, octisalate, octocrylene, oxybenzone, and avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58331-030
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (HOMOSALATE) HOMOSALATE10.5 g  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE5 g  in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE2 g  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE2 g  in 100 mL
Avobenzone (Avobenzone) Avobenzone2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITAN ISOSTEARATE 
SORBITOL 
TROLAMINE 
POLYGLYCERYL-3 DISTEARATE 
STEARIC ACID 
BARIUM SULFATE 
BENZYL ALCOHOL 
DIMETHICONE 1000 
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
METHYLPARABEN 
ALOE VERA LEAF 
JOJOBA OIL 
.ALPHA.-TOCOPHEROL 
PROPYLPARABEN 
EDETATE DISODIUM 
Packaging
#Item CodePackage Description
1NDC:58331-030-01120 mL in 1 BOTTLE, PLASTIC
2NDC:58331-030-0210 mL in 1 PACKET
3NDC:58331-030-0330 mL in 1 BOTTLE, PLASTIC
4NDC:58331-030-04180 mL in 1 BOTTLE, PLASTIC
5NDC:58331-030-051000 mL in 1 BOTTLE, PLASTIC
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: fe9065df-c87a-4d18-97e7-c78cfdade0a7
Set id: deef029f-2fbf-4ae7-b261-01d5d4a0f6c1
Version: 1
Effective Time: 20130429
 
Degil Safety Products (1989) Inc.