LEA BLACK BROAD SPECTRUM SPF 30 SUNSCREEN- titanium dioxide, zinc oxide lotion 
Prime Enterprises Inc.

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.

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Lea Black Sunscreen Lotion 250 mg CBD Broad Spectrum SPF 30

Active Ingredients

Titanium Dioxide 3%, Zinc Oxide 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.

Do not use

Do not use on damaged or broken skin

When using this product

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

Stop use and ask a doctor

Stop use and ask a doctor if rash occurs

Keep out of reach of children.

Keep out of reach of children. If 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. to 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Inactive Ingredients

Allantoin, Alumina, Butyrospermum Parkii (Shea) Butter, Camellia Oleifera (Green Tea) Leaf Extract, Cannabidiol, Cetyl PEG/PPG-10/1 Dimethicone, Cucumis Sativus (Cucumber) Extract, Cyclopentasiloxane, Dimethicone Crosspolymer, Disteardimonium Hectorite, Ethylhexylglycerin, Glycerin, Hexyl Laurate, Linum Usitatissimum (Linseed) Seed Oil, Oenothera Biennis (Evening Primrose) Oil, PEG-10 Dimethicone, Phenoxyethanol, Plankton Extract, Polyglyceryl-4 Isostearate, Polymethylsilsesquioxane, Rosa Canina Seed Oil, Silica, Stearic Acid, Tocopheryl Acetate, Water

Other Information

  • Protect this product from excessive heat and direct sun.
  • Avoid contact with fabrics - could cause discoloration.

Questions or comments?

hello@leablack.com

Lea Black Sunscreen Lotion 250 mg CBD Broad Spectrum SPF 30

Principle Display Label

LEA BLACK  BROAD SPECTRUM SPF 30 SUNSCREEN
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0421
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE30.84 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE30.84 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CANNABIDIOL (UNII: 19GBJ60SN5)  
CUCUMBER SEED (UNII: BT3S9L53JK)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
ROSA CANINA SEED (UNII: 4503R1M9UT)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
LINSEED OIL (UNII: 84XB4DV00W)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALLANTOIN (UNII: 344S277G0Z)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
WATER (UNII: 059QF0KO0R)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SHEA BUTTER (UNII: K49155WL9Y)  
Product Characteristics
Colorwhite (Off White) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0421-350 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/202106/30/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02006/01/202106/30/2024
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028manufacture(58443-0421) , label(58443-0421) , analysis(58443-0421) , pack(58443-0421)

Revised: 8/2022
 
Prime Enterprises Inc.