CHAPSTICK LIPSHIELD 365- avobenzone, dimethicone, homosalate, octinoxate, octisalate, oxybenzone stick
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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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Chapstick LipShield 365
(avobenzone, dimethicone, homosalate, octinoxate, octisalate, and oxybenzone)

DRUG FACTS

ACTIVE INGREDIENTS

Avobenzone 3%

Dimethicone 1.5%

Homosalate 6%

Octinoxate 6.5%

Octisalate 4.5%

Oxybenzone 5%

PURPOSE

Sunscreen

Skin Protectant

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)

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

Sealed For Your Protection

Twist Cap To Break Seal

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0573-1929-12	1 in 1 BLISTER PACK	07/01/2011	02/29/2016
1		4 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	07/01/2011	02/29/2016

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 4/2021

Document Id: eea2d60b-5dea-4581-a875-a2be4bb84a5a

Set id: b9a1dd35-3333-e73f-2049-27dac85a0d5f

Version: 3

Effective Time: 20210429

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Chapstick LipShield 365(avobenzone, dimethicone, homosalate, octinoxate, octisalate, and oxybenzone)