ORALABS CHAPICE CHERRY SPF 4 LIP BALM- padimate o, petrolatum stick

OraLabs ChapIce Cherry SPF 4 Lip Balm by

Drug Labeling and Warnings

OraLabs ChapIce Cherry SPF 4 Lip Balm by is a Otc medication manufactured, distributed, or labeled by OraLabs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Padimate O

Petrolatum

Purpose

Sunscreen

Skin Protectant

Uses

Helps prevent sunscreen

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.

Keep out of reach of children: if swallowed get medical help or contact a Poison Control Center right away.

Directions

Apply liberally before sun exposure and as needed.

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

Inactive ingredients

Mineral oil, Ozokerite, Flavor, Microcrystalline Wax, Isopropyl Myristate, Phenyl Trimethicone, Copernicia Cerifera (Carnauba) Wax, Lanolin, Euphorbia Cerifera (Candellia) Wax, Cetyl Alcohol, Campor, Red 6 Lake (C15850), Methylparaben

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

ORALABS CHAPICE CHERRY SPF 4 LIP BALM 
padimate o, petrolatum stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63645-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ)	PADIMATE O	15 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	440 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)	235 mg  in 1 g
CERESIN (UNII: Q1LS2UJO3A)	175 mg  in 1 g
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)	30 mg  in 1 g
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)	18.5 mg  in 1 g
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)	22.3 mg  in 1 g
CARNAUBA WAX (UNII: R12CBM0EIZ)	10 mg  in 1 g
LANOLIN (UNII: 7EV65EAW6H)	10 mg  in 1 g
CANDELILLA WAX (UNII: WL0328HX19)	5 mg  in 1 g
CETYL ALCOHOL (UNII: 936JST6JCN)	5 mg  in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)	2 mg  in 1 g
METHYLPARABEN (UNII: A2I8C7HI9T)	1 mg  in 1 g
CHERRY (UNII: BUC5I9595W)	30 mg  in 1 g
D&C RED NO. 6 (UNII: 481744AI4O)	12 mg  in 1 g

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63645-111-01	4.25 g in 1 CYLINDER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/03/2000

Labeler - OraLabs (801824756)

Registrant - OraLabs (801824756)

Establishment
Name	Address	ID/FEI	Business Operations
OraLabs		801824756	MANUFACTURE(63645-111)