EVERY MAN JACK BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene spray 
Prime Packaging, 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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Every Man Jack sunscreen spray Broad Spectrum SPF 30

Active Ingredients

Avobenzone 3%

Homosalate 7.5%

Octisalate 5%

Octocrylene 5%

Purpose

Sunscreen

Uses

Warnings

For external use only.

Do not use on damaged or broken skin

When using this product Keep away from face to avoid breathing it. 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 swalowed, get medical help or contact a Poison Control Center right away.

Flammable: Do not use near heat, flame or while smoking. Contents under pressure do not puncture or incinerate. Do not store at temperatures above 120°F

Directions

• shake well before use • apply liberally 15 minutes before sun exposure and rub into skin • hold container 4 to 6 inches from the skin to apply • do not spray directly onto face. Spray on hands then apply to face • do not apply in windy conditions • use in a well-ventilated area • 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. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses • children under 6 months: Ask a doctor

Inactive ingredients

Aloe Barbadensis Leaf Extract, Butyrospermum Parkii (Shea) Butter, Helianthus Annuus (Sunflower) Seed Oil, SD Alcohol 40-B, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Other information

• Protect this product from excessive heat and direct sun.

• Avoid spraying on fabrics - could cause discoloration.

Questions or comments?

877-875-5225, 9-5 PST weekdays

Every Man Jack sunscreen spray Broad Spectrum SPF 30

Principal Display Label

EVERY MAN JACK  BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0164
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
COCOA BUTTER (UNII: 512OYT1CRR)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ISOBORNYL ACRYLATE (UNII: IX0PRH184P)  
ALCOHOL (UNII: 3K9958V90M)  
VINYL ACETATE (UNII: L9MK238N77)  
DIBUTYL MALEATE (UNII: 4X371TMK9K)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
SHEA BUTTER (UNII: K49155WL9Y)  
Product Characteristics
Coloryellow (Pale yellow to yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0164-4170 g in 1 CAN; Type 0: Not a Combination Product06/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/10/2020
Labeler - Prime Packaging, Inc. (805987059)
Registrant - Prime Packaging, Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028manufacture(13630-0164) , analysis(13630-0164)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging, Inc.805987059label(13630-0164) , pack(13630-0164)

Revised: 10/2020
Document Id: b17a0b67-20b0-6a55-e053-2a95a90ab15a
Set id: b17a2a5c-2373-3b8c-e053-2995a90ab801
Version: 1
Effective Time: 20201012
 
Prime Packaging, Inc.