Label: CROC BLOC BROAD SPECTRUM SPF 30 FPS ECRAN SOLAIRE- homosalate, octisalate, octocrylene, oxybenzone, and avobenzone lotion

  • NDC Code(s): 58331-030-01, 58331-030-02, 58331-030-03, 58331-030-04, view more
    58331-030-05
  • Packager: Degil Safety Products (1989) Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    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

    Écran Solaire

    BROAD SPECTRUM • LARGE SPECTRE
    UVA/UVB PROTECTION

    CONTRE LES RAYONS UVA ET UVB

    Dermatologist Tested • Moisturizing Aloe & Vitamin E

    Unscented Lotion • Water Sweat Resistant (40 Minutes)
    Testé par les dermatologues • Hydratante avec Vitamine E et Aloés

    Lotion Non Parfumée • Résiste à l'eau

    Outer label

  • INGREDIENTS AND APPEARANCE
    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 AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10.5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    SORBITOL (UNII: 506T60A25R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58331-030-01120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/21/2022
    2NDC:58331-030-0210 mL in 1 PACKET; Type 0: Not a Combination Product11/21/2022
    3NDC:58331-030-0330 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/21/2022
    4NDC:58331-030-04180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/21/2022
    5NDC:58331-030-051000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/21/2022
    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 - CSR Cosmetic Solutions (243501959)
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