BLACK GIRL SUNSCREEN SUNGLOSS FOR LIPS- lidocaine hydrochloride gel 
Prime Enterprises Inc.

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Black Girl Sunscreen Make It Pop Sungloss for LIps Broad Spectrum SPF 50

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

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 Product01/10/202308/13/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/10/202308/13/2024
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)

Revised: 8/2024
 
Prime Enterprises Inc.