CARE ONE CHERRY SPF 4 LIP BALM- padimate o, petrolatum stick
American Sales Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

CARE ONE CHERRY SPF 4 LIP BALM
padimate o, petrolatum stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41520-978
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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
LANOLIN (UNII: 7EV65EAW6H)	1 mg in 1 g
CERESIN (UNII: Q1LS2UJO3A)	17.50 mg in 1 g
CARNAUBA WAX (UNII: R12CBM0EIZ)	1 mg in 1 g
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)	2.23 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:41520-978-02	1 g in 1 CONTAINER

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	03/15/2013

Labeler - American Sales Company (809183973)

Registrant - American Sales Company (809183973)

Name	Address	ID/FEI	Business Operations
Establishment
OraLabs		801824756	MANUFACTURE(41520-978) , LABEL(41520-978)