PANAMA JACK SPF 45 MANGO LIP BALM- avobenzone, homosalate, octinoxate, octisalate, petrolatum stick

Panama Jack SPF 45 Mango Lip Balm by

Drug Labeling and Warnings

Panama Jack SPF 45 Mango Lip Balm by is a Otc medication manufactured, distributed, or labeled by Panama Jack, OraLabs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

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

Purpose

Sunscreen, Skin Protectant

Keep Out of Reach of Children

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

Uses

Prevents Sunburns. Helps prevent wind burned and chapped lips.

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

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

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

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

PANAMA JACK SPF 45 MANGO LIP BALM 
avobenzone, homosalate, octinoxate, octisalate, petrolatum stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87449-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	30 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	400 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LIGHT MINERAL OIL (UNII: N6K5787QVP)	122 mg  in 1 g
CERESIN (UNII: Q1LS2UJO3A)	170 mg  in 1 g

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MANGO	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87449-201-01	4.25 g in 1 CONTAINER; Type 0: Not a Combination Product	02/26/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	352	02/26/2026

Labeler - Panama Jack (098368566)

Registrant - OraLabs (801824756)

Establishment
Name	Address	ID/FEI	Business Operations
OraLabs		801824756	manufacture(87449-201) , label(87449-201) , analysis(87449-201)