CHAPSTICK ULTRA SPF 30 - octinoxate, octisalate, octocrylene, oxybenzone and petrolatum stick
Pfizer Consumer Healthcare

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 INGREDIENTS

Octinoxate 7.5%

Octisalate 5%

Octocrylene 7%

Oxybenzone 5%

White petrolatum 30%

PURPOSES

Sunscreen

Skin protectant

USES

helps prevent sunburn
higher SPF gives more sunburn protection
helps prevent and temporarily protects chafed, chapped or cracked lips

WARNINGS

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 6 months of age: ask a doctor

OTHER INFORMATION

store at 20-25°C (68-77°F)

INACTIVE INGREDIENTS

aloe barbadensis leaf extract, alumina, arachidyl propionate, carnauba wax, cetyl alcohol, colloidal silicon dioxide, ethylhexyl palmitate, isopropyl lanolate, isopropyl myristate, lanolin, methylparaben, mineral oil, natural and artificial flavor, octyldodecanol, oleyl alcohol, paraffin, phenyl trimethicone, polyhydroxystearic acid, propylparaben, saccharin, silica, titanium dioxide, triacetin, vitamin E, white wax

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

ChapStick Ultra SPF 30

Skin Protectant/Sunscreen SPF 30

Protects from the Sun & Seals in Moisture for Softer, Healthier Lips

NET WT 0.15 OZ. (4 g)

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

Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

SEALED FOR YOUR PROTECTION

Twist Cap To Break Seal

ChapStick Ultra SPF Blister Pack Packaging

ChapStick Ultra 30 SPF30 Stick Packaging

CHAPSTICK ULTRA SPF 30
octinoxate, octisalate, octocrylene, oxybenzone, petrolatum stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0573-1940
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
octinoxate (octinoxate)	octinoxate	75 mg in 1 g
octisalate (octisalate)	octisalate	50 mg in 1 g
octocrylene (octocrylene)	octocrylene	70 mg in 1 g
oxybenzone (oxybenzone)	oxybenzone	50 mg in 1 g
petrolatum (petrolatum)	petrolatum	300 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF
ALUMINUM OXIDE
ARACHIDYL PROPIONATE
CARNAUBA WAX
CETYL ALCOHOL
ETHYLHEXYL PALMITATE
ISOPROPYL MYRISTATE
LANOLIN
METHYLPARABEN
MINERAL OIL
OCTYLDODECANOL
OLEYL ALCOHOL
PARAFFIN
PHENYL TRIMETHICONE
SACCHARIN
SILICON DIOXIDE
TITANIUM DIOXIDE
TRIACETIN
ALPHA-TOCOPHEROL
WHITE WAX

Product Characteristics
Color	WHITE (light ivory)	Score
Shape	BULLET (cylindrical)	Size	10mm
Flavor	LEMON, LIME	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:0573-1940-24	1 CYLINDER ( CYLINDER) in 1 BLISTER PACK	contains a CYLINDER
1		4 g in 1 CYLINDER	This package is contained within the BLISTER PACK (0573-1940-24)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/30/2004

Labeler - Pfizer Consumer Healthcare (828831730)

Establishment
Name	Address	ID/FEI	Operations
Fareva Richmond, Inc.		969523245	ANALYSIS, LABEL, MANUFACTURE, PACK, RELABEL, REPACK

Revised: 12/2011 Pfizer Consumer Healthcare