Label: GOODSENSE SPF 30 SUNSCREEN- avobenzone 3%, homosalate 10%, octisalate 5%, octocrylene 10% lotion

  • NDC Code(s): 50804-221-04
  • Packager: Geiss, Destin, & Dunn, 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 January 9, 2023

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  • Active Ingredients

    Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 10%

  • Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn

  • 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

    Acrylates/Octylacrylamide Copolymer, Benzyl Alcohol, Caprylic/Capric Triglyceride, Chlorphenesin, Diethylhexyl Syringylidenemalonate, Disodium EDTA, Ethylhexyl Palmitate, Fragrance, Oleth-3, Polyamide-8, Sodium Ascorbyl Phosphate, Sorbitol, Tocopherol, Triethanolamine, Water.

  • Label

    Label

  • INGREDIENTS AND APPEARANCE
    GOODSENSE SPF 30 SUNSCREEN 
    avobenzone 3%, homosalate 10%, octisalate 5%, octocrylene 10% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-221
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    OLETH-3 (UNII: BQZ26235UC)  
    POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    SORBITOL (UNII: 506T60A25R)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50804-221-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/21/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/21/2019
    Labeler - Geiss, Destin, & Dunn, Inc. (076059836)
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