SPL v3
SPL
SPL Set ID e28f38a6-f4b5-44fc-8ad4-8b76b72ed327
Route
TOPICAL
Published
Effective Date 2014-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (48.4 mg) Octisalate (29 mg) Oxybenzone (19.3 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 Methylisothiazolinone Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-02-25
Description

Octinoxate 5 %, Octisalate 3 % and Oxybenzone 2 %

Medication Information

Description

Octinoxate 5 %, Octisalate 3 % and Oxybenzone 2 %

Uses
  • helps prevent sunburn
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

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.

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
Other Information
  • protect this product from excesive heat and direct sun
Active Ingredients

Octinoxate 5 %, Octisalate 3 % 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, Water (Aqua), Xanthan Gum

Principal Display Panel  177 ml  bottle Label

Panama Jack

SPF 15

SUNSCREEN

Lotion

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
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

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.

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

Octinoxate 5 %, Octisalate 3 % 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, Water (Aqua), Xanthan Gum

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

Panama Jack

SPF 15

SUNSCREEN

Lotion

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: 2026-02-15T11:57:01.736046 · Updated: 2026-03-14T22:55:52.022027