Label: BLACK GIRL SUNSCREEN SPF 45- avobenzone, homosalate, octisalate, octocrylene gel

  • NDC Code(s): 58443-0629-3
  • Packager: Prime Enterprises, Inc.
  • Category: HUMAN OTC DRUG LABEL

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

    Avobenzone 3%

    Homosalate 10%

    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

    Do not useon damaged or broken skin

    When using this product

    When using this productkeep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor

    Stop use and ask a doctorif rash occurs

    Keep out of reach of children.

    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

    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 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 INGREDIENT

    Diisopropyl Adipate, Diisopropyl Sebacate, Cetyl Ethylhexanoate, Neopentyl Glycol Diethylhexanoate, Silica Silylate, VP/Hexadecene Copolymer, Silica, Butryospermum Parkii (Shea) Butter, Squalane, Tocopheryl Acetate, Cocos Nucifera (Coconut) Oil, Aloe Barbadensis Leaf Extract

  • Other information

    Protect this product form excessive heat and direct sun

  • PRINCIPAL DISPLAY LABEL - 1.7oz Black Girl Sunscreen Broad Spectrum SPF 45 Ultra Sheer Sunscreen Gel

    Principal Display Label

  • INGREDIENTS AND APPEARANCE
    BLACK GIRL SUNSCREEN  SPF 45
    avobenzone, homosalate, octisalate, octocrylene gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0629
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE95 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE47.5 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE28.5 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE95 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SQUALANE (UNII: GW89575KF9)  
    Product Characteristics
    Coloryellow (Light Yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0629-350 mL in 1 TUBE; 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, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028manufacture(58443-0629) , label(58443-0629) , analysis(58443-0629) , pack(58443-0629)
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