BASK BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene 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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BASK Sunscreen Lotion Broad Spectrum SPF 50

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 am – 2 pm

• Wear long-sleeve shirts, pants, hats, and sunglasses

• Children under 6 months: Ask a doctor.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Carbomer, Disodium EDTA, Ethylhexylglycerin, Fragrance, Hydroxypropyl Methylcellulose, Phenoxyethanol, Polyethylene, Polysorbate 20, Propylene Glycol, Sodium Hydroxide, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water

Other Information

• Protect this product in this container from excessive heat and direct sun

Questions or Comments

Call (631) 800-7SPF (800-7773) or hello@basksuncare.com

BASK Sunscreen Lotion Broad Spectrum SPF 50

Principle Display Label

BASK  BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0615
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE99 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
COCOA BUTTER (UNII: 512OYT1CRR)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CARBOMER 980 (UNII: 4Q93RCW27E)  
Product Characteristics
Colorwhite (White to Off-White) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0615-3100 mL in 1 TUBE; Type 0: Not a Combination Product01/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02001/30/2019
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0615) , manufacture(58443-0615) , label(58443-0615) , analysis(58443-0615)

Revised: 3/2023
Document Id: f67b6719-ab93-3fa6-e053-2995a90afa2a
Set id: f67a97b6-0512-38f0-e053-2995a90a06d3
Version: 2
Effective Time: 20230309
 
Prime Enterprises Inc.