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

  • NDC Code(s): 58331-050-01, 58331-050-02, 58331-050-03
  • Packager: Degil Safety Products (1989) Inc.
  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated November 21, 2022

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • 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

    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

  • INGREDIENTS AND APPEARANCE
    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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!