Label: BLACK GIRL SUNSCREEN SPF 50 BROAD SPECTRUM- homosalate, octocrylene, octisalate, zinc oxide lotion

  • NDC Code(s): 58443-0509-3
  • 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 14, 2022

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  • Active Ingredients

    Avobenzone 3%

    Homosalate 15%

    Octisalate 5%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreses 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
    • reapply
    • after 80 minutes of swimming or sweating
    • inmediately 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 of 15 or higher and other sun protection measures, including:
    • limit time in the sun, specially from 10 a.m. - 2 p.m.
    • wear long-sleeve shirts, pants, hats & sunglasses.
    • children under 6 months: Ask a doctor.
  • Inactive ingredients

    Acrylic Acid/VP Crosspolymer, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea) Butter, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Daucus Carota Sativa (Carrot) Seed Oil, Ethyl Ferulate, Glycerin, Glyceryl Caprylate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Seed Oil, Lavandula Angustifolia (Lavender) Oil, Olus Oil, Persea Gratissima (Avocado) Oil, Pongamia Pinnata Seed Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, Tetrasodium Glutamate Diacetate , Tocopheryl Acetate, Triethoxycaprylylsilane, VP/Acrylates/Lauryl Methacrylate Copolymer, Water

  • Other Information

    • protect this product from excessive heat and direct sun
  • Black Girl Sunscreen Mineral Combo Sunscreen Lotion for Face & Body Broad Spectrum SPF 50

    Principle Display Label

  • INGREDIENTS AND APPEARANCE
    BLACK GIRL SUNSCREEN  SPF 50 BROAD SPECTRUM
    homosalate, octocrylene, octisalate, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0509
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE50 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    CORN OIL (UNII: 8470G57WFM)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    ETHYL FERULATE (UNII: 5B8915UELW)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    MILLETTIA PINNATA SEED (UNII: C2BRV53B1V)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    CARROT SEED OIL (UNII: 595AO13F11)  
    WATER (UNII: 059QF0KO0R)  
    SUNFLOWER SEED (UNII: R9N3379M4Z)  
    JOJOBA OIL (UNII: 724GKU717M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    Product Characteristics
    Colorwhite (White to off white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0509-389 mL in 1 TUBE; Type 0: Not a Combination Product11/24/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/24/2021
    Labeler - Prime Enterprises Inc. (101946028)
    Registrant - Prime Enterprises Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc101946028manufacture(58443-0509) , analysis(58443-0509) , pack(58443-0509) , label(58443-0509)
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