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

Everyman Jack by

Drug Labeling and Warnings

Everyman Jack by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

EVERYMAN JACK  SPF 50
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0364
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	49.9 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	29.94 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	49.9 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	99.8 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (off white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0364-3	95 mL in 1 TUBE; Type 0: Not a Combination Product	06/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/30/2020

Labeler - Prime Enterprises (101946028)

Registrant - Prime Enterprises (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises		101946028	label(58443-0364) , manufacture(58443-0364) , analysis(58443-0364) , pack(58443-0364)