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NDC 13630-0259-04 Panama Jack 25.89; 129.45; 43.15; 86.3 g/mL; g/mL; g/mL; g/mL Details

Panama Jack 25.89; 129.45; 43.15; 86.3 g/mL; g/mL; g/mL; g/mL

Panama Jack is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Prime Packaging, Inc.. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE.

Product Information

NDC	13630-0259
Product ID	13630-0259_ecf9c4fb-d276-dc57-e053-2a95a90a0bf5
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Panama Jack
Proprietary Name Suffix	Sunscreen Broad Spectrum SPF75
Non-Proprietary Name	Avobenzone, Homosalate, Octisalate, Octocrylene
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	25.89; 129.45; 43.15; 86.3
Active Ingredient Units	g/mL; g/mL; g/mL; g/mL
Substance Name	AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Labeler Name	Prime Packaging, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	M020
Listing Certified Through	2024-12-31

Package

Package Images

NDC 13630-0259-04 (13630025904)

Pricing Information	N/A
NDC Package Code	13630-0259-4
Billing NDC	13630025904
Package	180 mL in 1 CAN (13630-0259-4)
Marketing Start Date	2022-03-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ecf9ba2e-255b-aa26-e053-2995a90a172a Details

Active Ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 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 with water to remove. Keep away from face to avoid breathing it. Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120ºF.

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.

Flammable:Do not use near heat, flame or while smoking.

Directions

Spray liberally and spread evenly by hand 15 minutes before sun exposure
Hold container 4 to 6 inches from the skin to apply
Do not spray directly into 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-sleeve shirts, pants, hats, and sunglasses
Children under 6 months: Ask a doctor

Inactive ingredients

SD Alcohol 40-B, Fragrance, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water

Other information

• Protect this product from excessive heat and direct sun.

• Avoid spraying on fabrics - could cause discoloration.

Questions or comments?

Call toll free 1-800-840-5225

Panama Jack Broad Spectrum SPF 75 Sunscreen Spray

INGREDIENTS AND APPEARANCE

PANAMA JACK SUNSCREEN BROAD SPECTRUM SPF75

avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13630-0259
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25.89 g in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	43.15 g in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	86.3 g in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	129.45 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ISOBORNYL ACRYLATE (UNII: IX0PRH184P)
ALCOHOL (UNII: 3K9958V90M)
VINYL ACETATE (UNII: L9MK238N77)
DIBUTYL MALEATE (UNII: 4X371TMK9K)

Product Characteristics
Color	yellow (Colorless to light yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13630-0259-4	180 mL in 1 CAN; Type 0: Not a Combination Product	03/21/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	03/21/2022

Labeler - Prime Packaging, Inc. (805987059)

Registrant - Prime Packaging, Inc. (805987059)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises, Inc.		101946028	manufacture(13630-0259) , analysis(13630-0259)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Packaging, Inc.		805987059	label(13630-0259) , pack(13630-0259)

Revised: 11/2022

Document Id: ecf9c4fb-d276-dc57-e053-2a95a90a0bf5

Set id: ecf9ba2e-255b-aa26-e053-2995a90a172a

Version: 1

Effective Time: 20221108