Drug Facts

Active ingredient

Padimate O, White Petrolatum

Purpose

Sunscreen, Skin Protectant

Keep Out of Reach of Children

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

Uses

Helps prevent sunburn. Helps prevent and temporarily protects dry, chapped, or wind burned 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 only to prevent sunburn, not skin cancer or early aging.

For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts.

Directions

Apply liberally before sun exposure and as needed.

Children under 6 months of age: Ask a doctor before use.

Inactive Ingredients

Mineral Oil, Ozokerite, Flavor, Microcrystalline Wax, Isopropyl Myristate, Phenyl Trimethicone, Copernicia Cerifera (Carnauba) Wax, Lanolin, Euphorbia Cerifera (Candelilla) Wax, Cetyl Alcohol, Camphor, Red 6 Lake (CI 15850), Methylparaben

Package/Label Principal Display Panel

LEADER CHERRY SPF 4 LIP BALM
padimate o, petrolatum stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37205-692
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ)	PADIMATE O	1.5 mg in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	44.0 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
LIGHT MINERAL OIL (UNII: N6K5787QVP)	23.50 mg in 1 g
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)	3.00 mg in 1 g
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)	2.23 mg in 1 g
CARNAUBA WAX (UNII: R12CBM0EIZ)	1 mg in 1 g
LANOLIN (UNII: 7EV65EAW6H)	1 mg in 1 g
CERESIN (UNII: Q1LS2UJO3A)	17.50 mg in 1 g

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37205-692-03	1 g in 1 CONTAINER; Type 0: Not a Combination Product	03/15/2013	01/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	03/15/2013	01/31/2019

Labeler - Cardinal Health (097537435)

Revised: 4/2025

Document Id: 9b2a544a-d998-4f63-8e86-8ad4fa28e87b

Set id: b0356d7d-86de-4d8f-beaf-6b5ffc68ab51

Version: 2

Effective Time: 20250418

Cardinal Health