PANAMA JACK SPF 8 WITH INSTANT BRONZER- ocinoxate and oxybenzone aerosol, 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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Panama Jack Sunscreen Continuous Spray Instant Bronzer Light Formula SPF 8

Active ingredients

Octinoxate 2 % and Oxybenzone 2 %

Purpose

Sunscreen

Uses

  • helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunbrun, not skin cancer or early skin aging.

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. Keep away from face to avoid breathing it. Content under pressure - do not puncture or incinerate. Do not store at temperatures above 120°F.

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

  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • Children under 6 months: Ask a doctor
  • Hold container 4 to 6 inches from the skin to apply
  • Do not spray directly into face. Spray hands then apply to face.
  • Do not apply in windy conditions. Use in well ventilated areas.
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Allantoin, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Caramel, Diazolidinyl Urea, Dimethicone, Disodium EDTA, Fragrance, Isopropylphthalimide, Methylparaben, Oleth 10, Propylene Glycol, Propylparaben, Retinyl Palmitate, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Trimethysiloxysilicate, water

Other information

  • protect this product from excesive heat and direct sun.
  • avoid spraying on fabrics-could cause discoloration.

Questions or Comments?

Call toll free 1-800-840-5225

PRINCIPAL DISPLAY PANEL - 177 mL Can Label

PRINCIPAL DISPLAY PANEL - 177 mL Can Label

Panama Jack

8

SUNSCREEN

CONTINUOUS SPRAY

INSTANT BRONZER

QUICK & EVEN

COVERAGE

LIGHT FORMULA

SPF 8

WATER RESISTANT

(80 MINUTES)

6 FL OZ (177 mL)

PANAMA JACK  SPF 8 WITH INSTANT BRONZER
ocinoxate and oxybenzone aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0085
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE19.6 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE19.6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C)  
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)  
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CARAMEL (UNII: T9D99G2B1R)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
OLETH-10 (UNII: JD797EF70J)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)  
THEOBROMA CACAO WHOLE (UNII: EB048G1S9J)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0085-4177 mL in 1 CAN; Type 0: Not a Combination Product12/29/201112/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/29/201112/31/2018
Labeler - Prime Packaging, Inc. (805987059)
Registrant - Prime Packaging, Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028manufacture(13630-0085) , analysis(13630-0085)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging, Inc.805987059label(13630-0085) , pack(13630-0085)

Revised: 4/2022
Document Id: dbda6e12-c393-cdc9-e053-2995a90a7b40
Set id: 131e6240-c282-4b04-b8d7-e45e8375f10e
Version: 4
Effective Time: 20220404
 
Prime Packaging, Inc.