LEADER ORIGINAL SPF 4 LIP BALM- padimate o, petrolatum stick

Leader Original SPF 4 Lip Balm by

Drug Labeling and Warnings

Leader Original SPF 4 Lip Balm by is a Otc medication manufactured, distributed, or labeled by Cardinal Health (Leader), OraLabs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Padimate O, 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 windburned 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, Microcrystalline Wax, Phenyl Trimethicone, Lanolin, Copercicia (Carnauba) Wax, Isopropyl Myristate, Cetyl Alcohol, Euphorbia Cerifera (Candelilla) Wax, Flavor, Camphor, Methylparaben, Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140), Red 6 Lake (CI 15850).

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

LEADER ORIGINAL SPF 4 LIP BALM 
padimate o, petrolatum stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-694
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)	3.00 mg  in 1 g
LANOLIN (UNII: 7EV65EAW6H)	1 mg  in 1 g
CERESIN (UNII: Q1LS2UJO3A)	17.30 mg  in 1 g
CARNAUBA WAX (UNII: R12CBM0EIZ)	1 mg  in 1 g
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)	2.23 mg  in 1 g
LIGHT MINERAL OIL (UNII: N6K5787QVP)	27.50 mg  in 1 g

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-694-03	1 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/15/2013

Labeler - Cardinal Health (Leader) (097537435)

Registrant - Cardinal Health (Leader) (097537435)

Establishment
Name	Address	ID/FEI	Business Operations
OraLabs		801824756	MANUFACTURE(37205-694) , LABEL(37205-694)