OTC Medication Information: OraLabs ChapIce Cherry SPF 4 Lip Balm

ORALABS CHAPICE CHERRY SPF 4 LIP BALM- padimate o and 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.

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 padimate o, petrolatum stick

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

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PADIMATE O (PADIMATE O) PADIMATE O 15 mg in 1 g PETROLATUM (PETROLATUM) PETROLATUM 440 mg in 1 g

Inactive Ingredients Ingredient Name Strength MINERAL OIL 235 mg in 1 g CERESIN 175 mg in 1 g MICROCRYSTALLINE WAX 30 mg in 1 g PHENYL TRIMETHICONE 18.5 mg in 1 g ISOPROPYL MYRISTATE 22.3 mg in 1 g CARNAUBA WAX 10 mg in 1 g LANOLIN 10 mg in 1 g CANDELILLA WAX 5 mg in 1 g CETYL ALCOHOL 5 mg in 1 g CAMPHOR (SYNTHETIC) 2 mg in 1 g METHYLPARABEN 1 mg in 1 g CHERRY 30 mg in 1 g D&C RED NO. 6 12 mg in 1 g

Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63645-111-01 4.25 g in 1 CYLINDER None

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	Operations
OraLabs		801824756	MANUFACTURE (63645-111)

Revised: 09/2012 OraLabs