Panama Jack SPF 45 Tropical Lip Balm

Manufacturer
Panama Jack | OraLabs
Effective date
2026-03-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:50:11

Key Label Information#

Active Ingredients And Purpose

Active ingredient

Avobenzone 3.0%, Homosalate 3.0%, Octinoxate 7.5%, Octisalate 5.0%................Sunscreen, Petrolatum 40.0%...........Skin Protectant

Purpose

Sunscreen, Skin Protectant

Uses

Uses

Prevents Sunburns. Helps prevent wind burned and chapped lips.

Warnings

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 to prevent sunburn, skin cancer and/or early aging. For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts.

Directions And Dosage

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 the 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 Label Information

Inactive Ingredients

C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Mineral Oil, Ozokerite, Phenyl Trimethicone, Tocopherol

Package/Label Principal Display Panel

Label Images#

LAB-2393-Tropical
LAB-2393-Tropical

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87449-203-01Panama Jack SPF 45 Tropical Lip Balm4.25 g in 1 CONTAINERSTICK4.251

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87449-20387449-203-01

Ingredients#

Complete SPL Sections#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%, Homosalate 3.0%, Octinoxate 7.5%, Octisalate 5.0%................Sunscreen, Petrolatum 40.0%...........Skin Protectant

Purpose

OTC - PURPOSE SECTION

Sunscreen, Skin Protectant

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact a Poison Control Center right away.

Uses

INDICATIONS & USAGE SECTION

Prevents Sunburns. Helps prevent wind burned and chapped lips.

Warnings

WARNINGS SECTION

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 to prevent sunburn, skin cancer and/or early aging. For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts.

Directions

DOSAGE & ADMINISTRATION SECTION

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 the 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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Mineral Oil, Ozokerite, Phenyl Trimethicone, Tocopherol

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML