BLACK GIRL SUNSCREEN SPF 50 BROAD SPECTRUM- avobenzone, homosalate, octisalate lotion 
Prime Enterprises Inc.

----------

Black Girl Sunscreen Kids Moisturizing Sunscreen Lotion for Face and Body 50 Broad Spectrum SPF 50

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

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea) Butter, Carbomer, Chamomilla Recutita (Matricaria) Flower Extract, Daucus Carota Sativa (Carrot) Seed Oil, Disodium EDTA, Ethylhexylglycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Lecithin, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Propylene Glycol, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, Sorbitan Oleate, Tocopheryl Acetate, Water

Other Information

  • protect this product from excessive heat and direct sun

Black Girl Sunscreen Kids Moisturizing Sunscreen Lotion for Face and Body 50 Broad Spectrum SPF 50

Principal Display Label

BLACK GIRL SUNSCREEN  SPF 50 BROAD SPECTRUM
avobenzone, homosalate, octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0294
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE29.16 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE145.8 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE48.6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CARROT SEED OIL (UNII: 595AO13F11)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SUNFLOWER SEED (UNII: R9N3379M4Z)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
JOJOBA OIL (UNII: 724GKU717M)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CARBOMER 980 (UNII: 4Q93RCW27E)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)  
SHEA BUTTER (UNII: K49155WL9Y)  
CHAMOMILE (UNII: FGL3685T2X)  
Product Characteristics
Colorwhite (White to off white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0294-389 mL in 1 TUBE; Type 0: Not a Combination Product04/29/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/29/2019
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc101946028manufacture(58443-0294) , analysis(58443-0294) , pack(58443-0294) , label(58443-0294)

Revised: 5/2024
 
Prime Enterprises Inc.