PANAMA JACK SPF 15- octinoxate, octisalate, and oxybenzone spray

Panama Jack by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients

Octinoxate 5 %, Octisalate 3 %, and Oxybenzone 2 %

PURPOSE

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 sunburn, 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.

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
• children under 6 months: Ask a doctor

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Allantoin, Aloe Barbadensis Leaf Juice, Butylphthalimide, Carrageenan, Citric Acid, Dimethicone, Disodium EDTA, Fragrance, Hydroxypropyl Methylcellulose, Isopropylphthalimide, Methylisothiazolinone, Methylparaben, Oleth 10, Propylene Glycol, Propylparaben, Soluble Collagen, Sorbitan Oleate, Tocopheryl Acetate, Triethanolamine, Trimethylsiloxysilicate, Water

Other information

• protect this product from excesive heat and direct sun

QUESTIONS

Questions or Comments?

Call toll free 1-800-840-5225           www.panamajack.com

PRINCIPAL DISPLAY PANEL - 237 mL  Bottle Label

Panama Jack

SPF 15

Spray Gel

SUNSCREEN

WATER RESISTANT (80 MINUTES)

Contains Aloe Vera and Vitamin E

Non Greasy and Hypoallergenic

8 FL OZ (237 mL)

INGREDIENTS AND APPEARANCE

PANAMA JACK  SPF 15
octinoxate, octisalate, and oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0046
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	49.5 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	29.7 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	19.8 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
3-BUTYLPHTHALIDE (UNII: 822Q956KGM)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)
HYPROMELLOSES (UNII: 3NXW29V3WO)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
OLETH-10 (UNII: JD797EF70J)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0046-4	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/15/2013

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	label(58443-0046) , pack(58443-0046) , manufacture(58443-0046) , analysis(58443-0046)