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NDC 63645-0130-02 ChapIce Original SPF 4 Lip Balm 1.5; 44 mg/g; mg/g Details

ChapIce Original SPF 4 Lip Balm 1.5; 44 mg/g; mg/g

ChapIce Original SPF 4 Lip Balm is a TOPICAL STICK in the HUMAN OTC DRUG category. It is labeled and distributed by OraLabs. The primary component is PADIMATE O; PETROLATUM.

Product Information

NDC	63645-0130
Product ID	63645-130_c4765775-122e-47a5-b712-0011a0b171e9
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	ChapIce Original SPF 4 Lip Balm
Proprietary Name Suffix	n/a
Non-Proprietary Name	Padimate O, Petrolatum
Product Type	HUMAN OTC DRUG
Dosage Form	STICK
Route	TOPICAL
Active Ingredient Strength	1.5; 44
Active Ingredient Units	mg/g; mg/g
Substance Name	PADIMATE O; PETROLATUM
Labeler Name	OraLabs
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63645-0130-02 (63645013002)

Pricing Information	N/A
NDC Package Code	63645-130-02
Billing NDC	63645013002
Package	1 g in 1 CONTAINER (63645-130-02)
Marketing Start Date	2013-03-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6ae352fa-3d4b-4720-b68b-f58b690a501f Details

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

CHAPICE ORIGINAL SPF 4 LIP BALM

padimate o, petrolatum stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63645-130
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
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63645-130-02	1 g in 1 CONTAINER; Type 0: Not a Combination Product	03/15/2013

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

Labeler - OraLabs (801824756)

Registrant - OraLabs (801824756)

Name	Address	ID/FEI	Business Operations
Establishment
OraLabs		801824756	MANUFACTURE(63645-130) , LABEL(63645-130)

Revised: 1/2022

Document Id: c4765775-122e-47a5-b712-0011a0b171e9

Set id: 6ae352fa-3d4b-4720-b68b-f58b690a501f

Version: 3

Effective Time: 20220127