CHAPSTICK MOISTURIZER- octinoxate, oxybenzone, and petrolatum stick

Chapstick Moisturizer by

Drug Labeling and Warnings

Chapstick Moisturizer by is a Otc medication manufactured, distributed, or labeled by Pfizer Consumer Healthcare, Fareva Richmond, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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)

INGREDIENTS AND APPEARANCE

CHAPSTICK MOISTURIZER 
octinoxate, oxybenzone, and petrolatum stick

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	35 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	387 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALUMINUM OXIDE (UNII: LMI26O6933)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISOCETYL STEARATE (UNII: 3RJ7186O9W)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LANOLIN (UNII: 7EV65EAW6H)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SACCHARIN (UNII: FST467XS7D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WHITE WAX (UNII: 7G1J5DA97F)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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)