Label: MY MEDIC SPF 30 REEF FRIENDLY SUNSCREEN- homosalate, titanium dioxide, ethylhexyl salicylate, phenylbenzimidazole sulfonic acid cream

  • NDC Code(s): 81417-009-01
  • Packager: Sled Distribution, LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 15, 2024

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

View All Sections
  • Active ingredient

    Homosalate 14%

    Titanium Dioxide 10%

    Ethylhexyl Salicylate 4.5%

    Phenylbenzimidazole Sulfonic Acid 1.5%

  • Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn.

    lf used as directed with other sunburn protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

  • Warnings

    • For external use only

    • Do not use on damaged or broken skin

    • When using this product keep out of eyes.

    Rinse with water to remove.

    • Stop use and ask a doctor if rash occurs

    • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • Apply to skin liberally, avoiding the eye area.
    • Wait at least 30 mins before sun exposure, or as directed by a physician.
    • Re-apply after 80 mniutes of swimming and/or sweating.
    • Re-apply immediately after towel drying and at least every 3 hours.
  • Inactive ingredients

    Aluminum Hydroxide, Bisabolol, Butyloctyl Salicylate, Caprylhydroxamic Acid, Dimethicone, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, lsohexadecane, Peg-100 Stearate, Polyacrylate Crosspolymer-6, Polyhydroxystearic Acid, Potassium Cetyl Phosphate, Propylene Glycol, Stearic Acid, Triethanolamine, VP Eicosene Copolymer, Water, Xanthan Gum, 1,2 Hexanediol

  • PRINCIPAL DISPLAY PANEL

    image of pouch label

  • INGREDIENTS AND APPEARANCE
    MY MEDIC SPF 30 REEF FRIENDLY SUNSCREEN 
    homosalate, titanium dioxide, ethylhexyl salicylate, phenylbenzimidazole sulfonic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81417-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE1.5 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE14 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81417-009-013.5 g in 1 POUCH; Type 0: Not a Combination Product10/31/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/31/2022
    Labeler - Sled Distribution, LLC (079772888)
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!