Label: BLACK GIRL SUNSCREEN SPF 50- octocrylene, octisalate, homosalate, avobenzone gel

  • 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 August 4, 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 swalloed, 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 this 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 am to 2 pm • 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 Make it Pop SPF 50 Sun Gloss for Lips

    Principal Display Label

  • INGREDIENTS AND APPEARANCE
    BLACK GIRL SUNSCREEN  SPF 50
    octocrylene, octisalate, homosalate, avobenzone gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0632
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE44.5 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE26.7 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE40.05 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE80.1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    POLYAMIDE-3 (20000 MW) (UNII: PLF06VZ9SQ)  
    POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
    STEVIA LEAF (UNII: 6TC6NN0876)  
    1-BUTENE (UNII: LY001N554L)  
    ETHYLENE (UNII: 91GW059KN7)  
    STYRENE (UNII: 44LJ2U959V)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    JOJOBA OIL (UNII: 724GKU717M)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PROPYLENE (UNII: AUG1H506LY)  
    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:58443-0632-24 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product08/04/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02008/04/2023
    Labeler - Prime Enterprises (101946028)
    Registrant - Prime Enterprises (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises101946028analysis(58443-0632) , label(58443-0632) , manufacture(58443-0632) , pack(58443-0632)
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