e891d868-be87-4f70-8a2c-79c2b611917d

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

Warnings

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
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
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

Description

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

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

Active Ingredients

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

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

Warnings

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
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
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

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

Active Ingredients (Active ingredients)

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

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