SPL v3
SPL
SPL Set ID e891d868-be87-4f70-8a2c-79c2b611917d
Route
TOPICAL
Published
Effective Date 2014-02-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (29.7 mg) Homosalate (99 mg) Octisalate (49.5 mg) Octocrylene (27.2 mg) Oxybenzone (19.8 mg)
Inactive Ingredients
Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) 3-butylphthalide Isopropylphthalimide Alkyl (c12-15) Benzoate Cetyl Alcohol Dimethicone Glyceryl Monostearate Edetate Disodium Peg-100 Stearate Phenoxyethanol High Density Polyethylene Propylene Glycol Water Green Tea Leaf Stearyl Alcohol .alpha.-tocopherol Acetate Trolamine Ubidecarenone Butyloctyl Salicylate Methylisothiazolinone Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-04-18
Description

Avobenzone 3 %, Homosalate 10 %, Octisalate 5 %, Octocrylene 2.75 %, and Oxybenzone 2 %

Medication Information

Description

Avobenzone 3 %, Homosalate 10 %, Octisalate 5 %, Octocrylene 2.75 %, and Oxybenzone 2 %

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
Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin.

Section 53413-1

Questions or Comments?

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

Email us at [email protected]

Section 55105-1

Purpose

Sunscreen

Section 60561-8

For external use only

Warnings

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
  • 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
Other Information
  • protect this product from excesive heat and direct sun
  • may stain some fabrics
Active Ingredients

Avobenzone 3 %, Homosalate 10 %, Octisalate 5 %, Octocrylene 2.75 %, and Oxybenzone 2 %

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Butylphthalimide, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Cetyl Alcohol, Dimethicone, Disodium EDTA, Fragrance (Parfum), Glyceryl Stearate, Isopropylphthalimide, Methylisothiazolinone, PEG-100 Stearate, Phenoxyethanol, Polyethylene, Propylene Glycol, Stearyl Alcohol, Tocopheryl Acetate, Triethanolamine, Ubiquinone, Undecylcrylene Dimethicone, Water (Aqua), Xanthan Gum

Principal Display Panel  177 ml  bottle Label

Panama Jack

SPF 50

SUNSCREEN

Lotion

BROAD SPECTRUM SPF 50

WATER RESISTANT (80 MINUTES)

Non Greasy & Hypoallergenic with

CoQ10 Antioxidant, Green Tea & Vitamin E

6 FL OZ (177 mL)

Structured Label Content

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
Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 53413-1 (53413-1)

Questions or Comments?

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

Email us at [email protected]

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 60561-8 (60561-8)

For external use only

Warnings

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
  • 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
Other Information (Other information)
  • protect this product from excesive heat and direct sun
  • may stain some fabrics
Active Ingredients (Active ingredients)

Avobenzone 3 %, Homosalate 10 %, Octisalate 5 %, Octocrylene 2.75 %, and Oxybenzone 2 %

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Butylphthalimide, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Cetyl Alcohol, Dimethicone, Disodium EDTA, Fragrance (Parfum), Glyceryl Stearate, Isopropylphthalimide, Methylisothiazolinone, PEG-100 Stearate, Phenoxyethanol, Polyethylene, Propylene Glycol, Stearyl Alcohol, Tocopheryl Acetate, Triethanolamine, Ubiquinone, Undecylcrylene Dimethicone, Water (Aqua), Xanthan Gum

Principal Display Panel  177 ml  bottle Label (PRINCIPAL DISPLAY PANEL - 177 mL  Bottle Label)

Panama Jack

SPF 50

SUNSCREEN

Lotion

BROAD SPECTRUM SPF 50

WATER RESISTANT (80 MINUTES)

Non Greasy & Hypoallergenic with

CoQ10 Antioxidant, Green Tea & Vitamin E

6 FL OZ (177 mL)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:01.746047 · Updated: 2026-03-14T22:55:52.022027