CHAPSTICK LIPSHIELD 365- avobenzone, dimethicone, homosalate, octinoxate, octisalate, oxybenzone stick

CHAPSTICK LIPSHIELD 365 by

Drug Labeling and Warnings

CHAPSTICK LIPSHIELD 365 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]

DRUG FACTS

ACTIVE INGREDIENTS

Avobenzone 3%

Dimethicone 1.5%

Homosalate 6%

Octinoxate 6.5%

Octisalate 4.5%

Oxybenzone 5%

PURPOSE

Sunscreen

Skin Protectant

Sunscreen

Sunscreen

Sunscreen

Sunscreen

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

alumina, butylene glycol, C12-15 alkyl benzoate, caprylic/capric triglyceride, caprylyl glycol, carnauba wax, castor oil phosphate, cetyl alcohol, colloidal silicon dioxide, diethylhexyl 2,6-naphthalate, ethylhexyl palmitate, hexylene glycol, hydrogenated poly (C6-14 olefin), isopropyl myristate, medium-chain triglycerides, methylparaben, natural and artificial flavor, paraffin, perfluorononyl dimethicone, phenoxyethanol, propylparaben, silica dimethyl silyate, sodium hyaluronate, sorbeth-2 hexaoleate, spilanthes acmella flower extract, sucralose, titanium dioxide, triethoxycaprylysilane, ubiquinone, vitamin E acetate, white wax

QUESTIONS OR COMMENTS?

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

PRODUCT PACKAGING

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

Chapstick LipShield 365

Skin Protectant/Sunscreen SPF 50+

Ingredients known to give superior moisturization

Maximum SPF protection for lips

All Seasons

New advanced formula

NET WT 0.15 OZ (4 g)

Dist. by: Pfizer, Madison, NJ 07940 USA © 2010 Pfizer Inc.

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

Sealed For Your Protection

Twist Cap To Break Seal

INGREDIENTS AND APPEARANCE

CHAPSTICK LIPSHIELD 365 
avobenzone, dimethicone, homosalate, octinoxate, octisalate, oxybenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0573-1929
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	15 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	60 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	65 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
METHYLPARABEN (UNII: A2I8C7HI9T)
PARAFFIN (UNII: I9O0E3H2ZE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ACMELLA OLERACEA FLOWER (UNII: 2794N5KM0K)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WHITE WAX (UNII: 7G1J5DA97F)

Product Characteristics
Color	WHITE (off white)	Score
Shape	BULLET (Cylindrical)	Size	42mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-1929-12	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	part352	07/01/2011

Labeler - Pfizer Consumer Healthcare (828831730)

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