EVERYMAN JACK SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion 
Prime Enterprises

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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Everyman Jack SPF 50 Sheer Face Lotion

Active Ingredient

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocryle 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 wih water to remove.

Stop use and ask a doctor

If rash occurs

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 and 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 the risk, regularly use a sunscreen with a broad spectrum SPF value 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

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea) Butter, Cetyl Alcohol, Cetyl Phosphate, Ethylhexylglycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Root Extract, PEG-100 Stearate, Phenoxyethanol, Phenyl Trimethicone, Polyethylene, Propylene Glycol, Silica, Sodium Hydroxide, Stearyl Alcohol, Tetrasodium Glutamate Diacetate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water

Ohter Information

Protect this product from excessive heat and direct sun.

Questions or Comments

877-875-5225, 9-5 PST weekdays.

Every Man Jack Face Shield Sun Protection Lotion SPF 50

Principal Display Label

EVERYMAN JACK  SPF 50
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0364
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE49.9 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE29.94 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE49.9 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE99.8 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SHEA BUTTER (UNII: K49155WL9Y)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
COCOA BUTTER (UNII: 512OYT1CRR)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CETYL PHOSPHATE (UNII: VT07D6X67O)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
Product Characteristics
Colorwhite (off white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0364-395 mL in 1 TUBE; Type 0: Not a Combination Product06/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/30/2020
Labeler - Prime Enterprises (101946028)
Registrant - Prime Enterprises (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises101946028label(58443-0364) , manufacture(58443-0364) , analysis(58443-0364) , pack(58443-0364)

Revised: 10/2020
Document Id: b11569ac-7f56-df22-e053-2a95a90a94c0
Set id: b11569ac-7f55-df22-e053-2a95a90a94c0
Version: 1
Effective Time: 20201007
 
Prime Enterprises