Label: DRS. PHARMACY SUNSCREEN SPF 50- sunscreen spf 50 lotion

  • NDC Code(s): 80489-235-01, 80489-235-02
  • Packager: OL PHARMA TECH LLC. (Drs. Pharmacy)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 1, 2024

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

  • ACTIVE INGREDIENTS

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

  • PURPOSE

    Sunscreen Agent

  • 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

    • May stain some fabrics and surfaces.

  • Do not use

    on damaged or broken skin

  • DOSAGE & ADMINISTRATION

    • 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 in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. – 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor
  • When using this product

    keep out of eyes. Rinse with water to remove it

  • 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.

  • Inctive ingredients

    Water, Carbomer,capric/caprylic Triglyceride, Glycerin, Sodium Hydroxide, Propylene Glycol, Xanthan Gum, methyl glycose sesquistearate,PEG-20 methyl glycose sesquistearate, Cyclomethicone, Behenyl alcohol, Isopropyl isostearate, phenoxyethanol, Methyl Gluceth-20, Disodium EDTA.

  • other information

    protect this product from excessive heat and direct sunlight

  • Questions

    www.drspharmacyusa.com

  • PRINCIPAL DISPLAY PANEL

    SPF 50 LOTION

  • INGREDIENTS AND APPEARANCE
    DRS. PHARMACY SUNSCREEN SPF 50 
    sunscreen spf 50 lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80489-235
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PEG-20 METHYL GLUCOSE SESQUISTEARATE (UNII: 0345752X7U)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)  
    SODIUM HYDRIDE (UNII: 23J3BHR95O)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80489-235-01133 g in 1 TUBE; Type 0: Not a Combination Product01/01/2024
    2NDC:80489-235-02118 g in 1 TUBE; Type 0: Not a Combination Product01/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/01/2024
    Labeler - OL PHARMA TECH LLC. (Drs. Pharmacy) (021170377)
    Registrant - OL PHARMA TECH LLC. (021170377)
    Establishment
    NameAddressID/FEIBusiness Operations
    OL PHARMA TECH LLC., (Drs. Pharmacy)021170377manufacture(80489-235)