RxNorm Names

Not yet provided

CHAPSTICK MOISTURIZER (octinoxate, oxybenzone, and petrolatum) stick
[Pfizer Consumer Healthcare]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1153b82e-bd37-413e-ad8b-c0d9451262d7

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph final

NOTE: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.

Drug Label Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

Drug Facts

Active ingredients	Purposes
Octinoxate 7.5%
Oxybenzone 3.5%	Sunscreens
White petrolatum 38.7%	Skin protectant

Purposes

Sunscreen

Uses

helps prevent and temporarily protects chafed, chapped or cracked lips
helps prevent sunburn
helps prevent and protect from the drying effects of wind and cold weather

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 help prevent sunburn, not skin cancer or early skin aging.

For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

When using this product keep out of eyes. Rinse with water to remove.

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

Directions

apply liberally 15 minutes before sun exposure
reapply at least every 2 hours
use a water resistant sunscreen if swimming or sweating
children under 6 months of age: Ask a doctor

Other information

store at 20-25°C (68-77°F)
protect this product from excessive heat and direct sun.

Inactive ingredients

aloe barbadensis leaf extract, alumina, artificial flavor, blue 1 lake, carnauba wax, cetyl alcohol, ethylhexyl palmitate, isocetyl stearate, isopropyl lanolate, isopropyl myristate, lanolin, medium-chain triglycerides, methylparaben, mineral oil, paraffin, polyhydroxystearic acid, propylparaben, red 6 lake, saccharin, silica, titanium dioxide, vitamin E acetate, white wax

Questions or comments?

call weekdays from 9 AM to 5 PM EST at 1-877-227-3421

For most recent product information, visit www.chapstick.com

PRINCIPAL DISPLAY PANEL - 4 g Cylinder Blister Pack

BRAND LIP CARE
ChapStick®

SKIN PROTECTANT | SUNSCREEN
SPF 15

MOISTURIZER
RASPBERRY CRÈME

ULTRA-HYDRATING FORMULA WITH
10 MOISTURIZERS AND SPF 15

NET WT 0.15 OZ (4 g)

Principal Display Panel - 4 g Cylinder Blister Pack

CHAPSTICK MOISTURIZER
octinoxate, oxybenzone, and petrolatum stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0573-1927
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (OCTINOXATE)	OCTINOXATE	75 mg in 1 g
OXYBENZONE (OXYBENZONE)	OXYBENZONE	35 mg in 1 g
PETROLATUM (PETROLATUM)	PETROLATUM	387 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF
ALUMINUM OXIDE
CARNAUBA WAX
CETYL ALCOHOL
ETHYLHEXYL PALMITATE
ISOCETYL STEARATE
ISOPROPYL MYRISTATE
LANOLIN
MEDIUM-CHAIN TRIGLYCERIDES
METHYLPARABEN
MINERAL OIL
PARAFFIN
POLYHYDROXYSTEARIC ACID (2300 MW)
PROPYLPARABEN
SACCHARIN
SILICON DIOXIDE
TITANIUM DIOXIDE
TRIACETIN
.ALPHA.-TOCOPHEROL ACETATE
WHITE WAX

Product Characteristics
Color		Score
Shape	BULLET (cylindrical)	Size	42mm
Flavor	RASPBERRY (Raspberry Creme)	Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:0573-1927-12	1 in 1 BLISTER PACK
1		4 g in 1 CYLINDER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	08/03/2012

Labeler - Pfizer Consumer Healthcare (828831730)

Establishment
Name	Address	ID/FEI	Business Operations
Fareva Richmond, Inc.		969523245	ANALYSIS(0573-1927), LABEL(0573-1927), MANUFACTURE(0573-1927), PACK(0573-1927), RELABEL(0573-1927), REPACK(0573-1927)

Revised: 09/2012

Document Id: 51c60a46-fcde-4b17-97da-804b05cc994a

Set id: 1153b82e-bd37-413e-ad8b-c0d9451262d7

Version: 1

Effective Time: 20120910

Pfizer Consumer Healthcare

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