Label: QC SPF 50 SUNSCREEN- avobenzone 3%, homosalate 15%, octisalate 5%, octocrylene 10% lotion

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 15, 2024

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  • Active Ingredients

    Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%

  • 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, sorbitol, aluminum starch octenylsuccinate, VP/eicosene copolymer, stearic acid, dimethicone, tocopherol, carbomer, disodium EDTA, ethylhexylglycerin, phenoxyethanol, polyglyceryl-3 methylglucose distearate, sorbitan isostearate, benzyl alcohol, triethanolamine, fragrance.

  • Label

    LabelLabel

  • INGREDIENTS AND APPEARANCE
    QC SPF 50 SUNSCREEN 
    avobenzone 3%, homosalate 15%, octisalate 5%, octocrylene 10% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-531
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (UNII: W19EIO0DBE)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    SORBITOL (UNII: 506T60A25R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-531-08227 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/22/2021
    2NDC:63868-531-18227 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/22/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/22/2021
    Labeler - CDMA (011920774)
    Registrant - Derma Care Research Labs, LLC (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs116817470manufacture(63868-531)