SPL v3
SPL
SPL Set ID 4783911d-afb2-488c-9666-561c5bd5150e
Route
TOPICAL
Published
Effective Date 2014-02-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (16.8 mg)
Inactive Ingredients
Peanut Oil Lemon Oil Mineral Oil Coconut Oil Aloe Vera Leaf Olive Oil Propylparaben Almond Oil Cocoa Butter

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-01-24

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

Section 55105-1

Purpose

Sunscreen

Section 60561-8

Warnings

Directions
  • apply liberally 15 minutes before sun exposure
  • reapply
    • at least every 2 hours
  • children under 6 months: Ask a doctor

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

Octinoxate 2 %

Inactive Ingredients

Aloe Barbadensis Extract, Arachis Hypogaea (Peanut) Oil, Citrus Medica Limonum (Lemon) Peel Oil, Cocos Nucifera (Coconut) Oil, Fragrance, Mineral Oil, Olea Europaea (Olive) Fruit Oil, Propylparaben, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Theobroma Cacao (Cocoa) Seed Butter

Skin Cancer/skin Aging Alert.

For external use only

Principal Display Panel  237 ml  bottle Label



Panama jack

SPF 4

Dark

Tanning Oil

Exotic Natural Oils

Fruit & Nut Extracts

Light Sunscreen Formula

8 FL OZ (237 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

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 60561-8 (60561-8)

Warnings

Directions
  • apply liberally 15 minutes before sun exposure
  • reapply
    • at least every 2 hours
  • children under 6 months: Ask a doctor

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

Octinoxate 2 %

Inactive Ingredients

Aloe Barbadensis Extract, Arachis Hypogaea (Peanut) Oil, Citrus Medica Limonum (Lemon) Peel Oil, Cocos Nucifera (Coconut) Oil, Fragrance, Mineral Oil, Olea Europaea (Olive) Fruit Oil, Propylparaben, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Theobroma Cacao (Cocoa) Seed Butter

Skin Cancer/skin Aging Alert. (Skin Cancer/Skin Aging Alert.)

For external use only

Principal Display Panel  237 ml  bottle Label (PRINCIPAL DISPLAY PANEL - 237 mL  Bottle Label)



Panama jack

SPF 4

Dark

Tanning Oil

Exotic Natural Oils

Fruit & Nut Extracts

Light Sunscreen Formula

8 FL OZ (237 mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)