Label: BLACK GIRL SUNSCREEN SPF45- avobenzone, homosalate, octisalate, octocrylene gel

  • NDC Code(s): 58443-0398-3
  • 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 February 4, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Active Ingredients

    Avobenzone 3%

    Homosalate 10%

    Octisalate 5%

    Octocrylene 5%

  • 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

    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 ingredients

    Aloe Barbadensis Leaf Extract, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Dimethicone Crosspolymer-3, Isododecane, Silica, Squalane, Tocopheryl Acetate

  • Other information:

    protect this product from excessive heat and direct sun

  • Black Girl Sunscreen Make It Matte Broad Spectrum SPF 45

    Principal Display Label

  • INGREDIENTS AND APPEARANCE
    BLACK GIRL SUNSCREEN  SPF45
    avobenzone, homosalate, octisalate, octocrylene gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0398
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE79 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE39.5 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE23.7 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE39.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SHEA BUTTER (UNII: K49155WL9Y)  
    ISODODECANE (UNII: A8289P68Y2)  
    SQUALANE (UNII: GW89575KF9)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Product Characteristics
    Coloryellow (Light Yellow to Yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0398-350 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/19/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/19/2021
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028manufacture(58443-0398) , pack(58443-0398) , label(58443-0398) , analysis(58443-0398)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!