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

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

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

OraLabs ChapIce Cherry SPF 4 Lip Balm.jpg

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

Labeler - OraLabs (801824756)

Registrant - OraLabs (801824756)

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