Label: INTENSE CARE GOLD 24K SNAIL SUN- homosalate, octisalate, ensulizole, octocrylene cream

  • 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 August 31, 2017

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Active ingredients: Homosalate 7.0%, Ethylhexyl Salicylate 4.5%, Phenylbenzimidazole Sulfonic Acid 3.0%, Octocrylene 1.0%

  • INACTIVE INGREDIENT

    Inactive ingredients: Water, Snail Secretion Filtrate, Butylene Glycol, Methyl Methacrylate Crosspolymer, C12-15 Alkyl Benzoate, Butyl Methoxydibenzoylmethane, Silica, Hydrogenated Polydecene, Niacinamide, Dipropylene Glycol, Glyceryl Stearate, Cetearyl Alcohol, Cetearyl Olivate, Sorbitan Olivate, Polysorbate 60, Dimethicone, Sodium Hydroxide, Caprylyl Glycol, Sorbitan Stearate, Polyacrylate-13, PEG-100 Stearate, Ethylhexylglycerin, Tocopheryl Acetate, Citrus Limon (Lemon) Peel Oil, Polyisobutene, Disodium EDTA, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, BHT, 1,2-Hexanediol, Adenosine, Polysorbate 20, Citrus Aurantium Dulcis (Orange) Peel Oil, Sorbitan Isostearate, Citrus Aurantifolia (Lime) Oil, Pinus Sylvestris Leaf Oil, Chamaecyparis Obtusa Water, Eucalyptus Globulus Leaf Oil, Glycerin, Imperata Cylindrica Root Extract, Propanediol, Panthenol, PEG-8, Phenoxyethanol, Carbomer, Centella Asiatica Extract, Carica Papaya (Papaya) Fruit Extract, Aloe Barbadensis Leaf Juice, Beta-Glucan, Potassium Sorbate, Gold, Sodium Benzoate

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    Warnings: For external use only Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use. Keep Out of Reach of Children

  • DESCRIPTION

    Uses: - Helps prevent sunburn - If used as directed with other sun protection measures

    Directions: During the last step of basic skin care, dispense an appropriate amount and evenly apply to any skin that will be exposed to ultraviolet light.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    INTENSE CARE GOLD 24K SNAIL SUN 
    homosalate, octisalate, ensulizole, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-325
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate3.50 g  in 50 mL
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate2.25 g  in 50 mL
    Ensulizole (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) Ensulizole1.50 g  in 50 mL
    Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene0.50 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59078-325-021 in 1 CARTON08/01/2017
    1NDC:59078-325-0150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/01/2017
    Labeler - TONYMOLY CO.,LTD (688216798)
    Registrant - TONYMOLY CO.,LTD (688216798)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmecca Korea Co., Ltd.688830827manufacture(59078-325)
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, PubMed, Biochemical Data Summary

More Info on this Drug

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