Label: ROD AND RIFLE SPF 50 SUNSCREEN- avobenzone 3%, homosalate 10%, octocrylene 6% lotion

  • NDC Code(s): 72839-247-05, 72839-247-32
  • Packager: Derma Care Research Labs, LLC
  • 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 May 23, 2023

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  • Active Ingredients

    Avobenzone 3%, Homosalate 10%, Octocrylene 6%

  • Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn. If used as directed with other sun 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 eyes with water to remove.

    Stop use and ask a doctor if rash occurs.

  • Keep Out of Reach of Children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply liberally 15 minutes before sun exposure. Reapply:

    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours

    Sun protection measures: spending time n the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measure including:

    • limit time in the sun, especially from 10 am to 2 pm
    • wear long-sleeved shirts, pants, hats, and sunglasses.
    • Children under 6 months: ask a doctor.

  • Inactive Ingredients

    Water, Butyloctyl Salicylate, Sorbitol, Aluminum Starch Octenylsuccinate, VP/Eicosene Copolymer, Stearic Acid, Dimethicone, Phenoxyethanol, Ethylhexylglycerin, Polyglyceryl-3 Methylglucose Distearate, Sorbitan Isostearate, Triethanolamine, Carbomer, Disodium EDTA.

  • Label

    LabelLabel

  • INGREDIENTS AND APPEARANCE
    ROD AND RIFLE SPF 50 SUNSCREEN 
    avobenzone 3%, homosalate 10%, octocrylene 6% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72839-247
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE6 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    DIMETHICONE 200 (UNII: RGS4T2AS00)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72839-247-05148 mL in 1 TUBE; Type 0: Not a Combination Product05/19/2022
    2NDC:72839-247-32946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/20/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/19/2022
    Labeler - Derma Care Research Labs, LLC (116817470)
    Registrant - Derma Care Research Labs, LLC (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs116817470manufacture(72839-247)
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