SPL v3
SPL
SPL Set ID abb9c3b3-b33b-41eb-8acd-5c4a7a93b63f
Route
TOPICAL
Published
Effective Date 2014-02-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (19.3 mg)
Inactive Ingredients
Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Alkyl (c12-15) Benzoate Cetyl Alcohol Dimethicone Edetate Disodium Glyceryl Monostearate 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 2013-01-12

Description

Octinoxate 2 %


Medication Information

Description

Octinoxate 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

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
  • children under 6 months: Ask a doctor
Skin Cancer/skin

For external use only

Other Information

  • protect this product from excessive heat and direct sun
Active Ingredients

Octinoxate 2 %

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Cetyl Alcohol, Dimethicone, Disodium EDTA, Fragrance (Parfum), Glyceryl Stearate, 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 4

Dark Tanning Lotion

WATER RESISTANT (80 MINUTES)

Non Greasy & Hypoallergenic with

CoQ10 Antioxidant, Green Tea & Vitamin E

6 FL OZ (177mL)


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)

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
  • children under 6 months: Ask a doctor
Skin Cancer/skin (Skin Cancer/Skin)

For external use only

Other Information (Other information)

  • protect this product from excessive heat and direct sun
Active Ingredients (Active ingredients)

Octinoxate 2 %

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Cetyl Alcohol, Dimethicone, Disodium EDTA, Fragrance (Parfum), Glyceryl Stearate, 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 4

Dark Tanning Lotion

WATER RESISTANT (80 MINUTES)

Non Greasy & Hypoallergenic with

CoQ10 Antioxidant, Green Tea & Vitamin E

6 FL OZ (177mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)