Label: BLACK GIRL SUNSCREEN SUNGLOSS FOR LIPS- lidocaine hydrochloride gel

  • NDC Code(s): 58443-0606-2
  • Packager: Prime Enterprises Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 11, 2023

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  • Active Ingredients

    Octocrylene 9%

    Octisalate 5%

    Homosalate 4.5%

    Avobenzone 3%

  • 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 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 liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply 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 the risk, regularly use a sunscreen with a Broad Spectrum SPF 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.
  • Inactive Ingredients

    Benzyl Alcohol, Butylene/Ethylene/Styrene Copolymer, C12-15 Alkyl Benzoate, Ethylene/Propylene/Styrene Copolymer, Ethylhexyl Olivate , Flavor, Glyceryl Caprylate, Glyceryl Undecylenate, Isohexadecane, Persea Gratissima (Avocado) Oil, Polyamide-3, Polybutene, Silica Cetyl Silylate, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hyaluronate , Stevia Rebaudiana Leaf Extract, Tocopheryl Acetate, Tripeptide-1, Xanthan Gum

  • Other Information

    • Protect this product from excessive heat and direct sun
  • Black Girl Sunscreen Make It Pop Sun Gloss for LIps Broad spectrum SPF 50

    Principle Display Label

  • INGREDIENTS AND APPEARANCE
    BLACK GIRL SUNSCREEN  SUNGLOSS FOR LIPS
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0606
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE40.05 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE44.5 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE26.7 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE80.1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    POLYAMIDE-3 (12000 MW) (UNII: L7P3YWF22X)  
    POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
    ETHYLHEXYL OLEATE (UNII: R34927QY59)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    JOJOBA OIL (UNII: 724GKU717M)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    PREZATIDE (UNII: 39TG2H631E)  
    Product Characteristics
    Coloryellow (Hint of Yellow to Light Yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0606-24 mL in 1 TUBE; Type 0: Not a Combination Product01/10/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02001/10/2023
    Labeler - Prime Enterprises Inc. (101946028)
    Registrant - Prime Enterprises Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc.101946028pack(58443-0606) , manufacture(58443-0606) , label(58443-0606) , analysis(58443-0606)
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