CHAPSTICK CLASSICS STRAWBERRY- padimate o, petrolatum stick
CHAPSTICK CLASSICS CHERRY- padimate o, petrolatum stick
CHAPSTICK CLASSICS SPEARMINT- padimate o, petrolatum stick
CHAPSTICK CLASSICS ORIGINAL- padimate o, petrolatum 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 Classic Original
ChapStick Classic Cherry
ChapStick Classic Strawberry
ChapStick Classic Spearmint
(padimate O and white petrolatum)

DRUG FACTS

ACTIVE INGREDIENTS

Padimate O 1.5%

White petrolatum 44%

PURPOSES

Sunscreen

Skin protectant

USES

•: helps prevent and temporarily protects chafed, chapped or cracked lips
•: helps prevent and protects from the drying effects of wind and cold weather
•: helps prevent sunburn
•: higher SPF gives more sunburn protection

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

Chapstick Classic Original

arachidyl propionate, camphor, carnauba wax, cetyl alcohol, D&C red no. 6 barium lake, FD&C yellow no. 5 aluminum lake, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, methylparaben, octyldodecanol, oleyl alcohol, paraffin, phenyl trimethicone, propylparaben, titanium dioxide, white wax

Chapstick Classic Cherry

arachidyl propionate, camphor, carnauba wax, cetyl alcohol, D&C red no. 6 barium lake, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, menthol, methylparaben, octyldodecanol, paraffin, phenyl trimethicone, propylparaben, saccharin, white wax

Chapstick Classic Strawberry

arachidyl propionate, camphor, carnauba wax, cetyl alcohol, D&C red no. 6 barium lake, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, lemon oil, light mineral oil, maltol, methylparaben, octyldodecanol, paraffin, phenyl trimethicone, propylparaben, saccharin, white wax

Chapstick Classic Spearmint

arachidyl propionate, carnauba wax, cetyl alcohol, FD&C blue no. 1 aluminum lake, FD&C yellow no. 5 aluminum lake, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, maltol, menthol, methylparaben, octyldodecanol, paraffin, phenyl trimethicone, propylparaben, saccharin, spearmint oil, white wax

PRODUCT PACKAGING

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

ChapStick CLASSIC ORIGINAL

ChapStick CLASSIC CHERRY

ChapStick CLASSIC STRAWBERRY

ChapStick CLASSIC SPEARMINT

Skin Protectant/Sunscreen SPF 4

Protects to Help Heal for Softer, Healthier Lips Every Day

NET WT. 0.15 OZ. (4 g)

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.

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

SEALED FOR YOUR PROTECTION

Twist Cap to Break Seal

CHAPSTICK CLASSICS STRAWBERRY
padimate o, petrolatum stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0573-1915
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
padimate o (UNII: Z11006CMUZ) (padimate o - UNII:Z11006CMUZ)	padimate o	15 mg in 1 g
petrolatum (UNII: 4T6H12BN9U) (petrolatum - UNII:4T6H12BN9U)	petrolatum	440 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
arachidyl propionate (UNII: QV5DAH3MSB)
camphor (synthetic) (UNII: 5TJD82A1ET)
carnauba wax (UNII: R12CBM0EIZ)
cetyl alcohol (UNII: 936JST6JCN)
D&C red no. 6 (UNII: 481744AI4O)
isopropyl myristate (UNII: 0RE8K4LNJS)
lanolin (UNII: 7EV65EAW6H)
lemon oil (UNII: I9GRO824LL)
light mineral oil (UNII: N6K5787QVP)
maltol (UNII: 3A9RD92BS4)
methylparaben (UNII: A2I8C7HI9T)
octyldodecanol (UNII: 461N1O614Y)
paraffin (UNII: I9O0E3H2ZE)
phenyl trimethicone (UNII: DR0K5NOJ4R)
propylparaben (UNII: Z8IX2SC1OH)
saccharin (UNII: FST467XS7D)
white wax (UNII: 7G1J5DA97F)

Product Characteristics
Color	PINK (pinkish red)	Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0573-1915-24	1 in 1 BLISTER PACK	01/01/2004	06/28/2018
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	part347	01/01/2004	06/28/2018

CHAPSTICK CLASSICS CHERRY
padimate o, petrolatum stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0573-1905
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
padimate o (UNII: Z11006CMUZ) (padimate o - UNII:Z11006CMUZ)	padimate o	15 mg in 1 g
petrolatum (UNII: 4T6H12BN9U) (petrolatum - UNII:4T6H12BN9U)	petrolatum	440 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
arachidyl propionate (UNII: QV5DAH3MSB)
camphor (synthetic) (UNII: 5TJD82A1ET)
carnauba wax (UNII: R12CBM0EIZ)
cetyl alcohol (UNII: 936JST6JCN)
D&C red no. 6 (UNII: 481744AI4O)
isopropyl myristate (UNII: 0RE8K4LNJS)
lanolin (UNII: 7EV65EAW6H)
light mineral oil (UNII: N6K5787QVP)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
methylparaben (UNII: A2I8C7HI9T)
octyldodecanol (UNII: 461N1O614Y)
paraffin (UNII: I9O0E3H2ZE)
phenyl trimethicone (UNII: DR0K5NOJ4R)
propylparaben (UNII: Z8IX2SC1OH)
saccharin (UNII: FST467XS7D)
white wax (UNII: 7G1J5DA97F)

Product Characteristics
Color	PINK (dark pinkish)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0573-1905-24	1 in 1 BLISTER PACK	01/28/2004	06/28/2018
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	part347	01/28/2004	06/28/2018

CHAPSTICK CLASSICS SPEARMINT
padimate o, petrolatum stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0573-1911
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
padimate o (UNII: Z11006CMUZ) (padimate o - UNII:Z11006CMUZ)	padimate o	15 mg in 1 g
petrolatum (UNII: 4T6H12BN9U) (petrolatum - UNII:4T6H12BN9U)	petrolatum	440 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
arachidyl propionate (UNII: QV5DAH3MSB)
carnauba wax (UNII: R12CBM0EIZ)
cetyl alcohol (UNII: 936JST6JCN)
FD&C blue no. 1 (UNII: H3R47K3TBD)
FD&C yellow no. 5 (UNII: I753WB2F1M)
isopropyl myristate (UNII: 0RE8K4LNJS)
lanolin (UNII: 7EV65EAW6H)
light mineral oil (UNII: N6K5787QVP)
maltol (UNII: 3A9RD92BS4)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
methylparaben (UNII: A2I8C7HI9T)
octyldodecanol (UNII: 461N1O614Y)
paraffin (UNII: I9O0E3H2ZE)
phenyl trimethicone (UNII: DR0K5NOJ4R)
propylparaben (UNII: Z8IX2SC1OH)
saccharin (UNII: FST467XS7D)
MENTHA SPICATA OIL (UNII: C3M81465G5)
white wax (UNII: 7G1J5DA97F)

Product Characteristics
Color	GREEN (mint green)	Score
Shape		Size
Flavor	SPEARMINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0573-1911-24	1 in 1 BLISTER PACK	01/01/2004	06/28/2018
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	part347	01/01/2004	06/28/2018

CHAPSTICK CLASSICS ORIGINAL
padimate o, petrolatum stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0573-1900
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
padimate o (UNII: Z11006CMUZ) (padimate o - UNII:Z11006CMUZ)	padimate o	15 mg in 1 g
petrolatum (UNII: 4T6H12BN9U) (petrolatum - UNII:4T6H12BN9U)	petrolatum	440 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
arachidyl propionate (UNII: QV5DAH3MSB)
camphor (synthetic) (UNII: 5TJD82A1ET)
carnauba wax (UNII: R12CBM0EIZ)
cetyl alcohol (UNII: 936JST6JCN)
D&C red no. 6 (UNII: 481744AI4O)
FD&C yellow no. 5 (UNII: I753WB2F1M)
isopropyl myristate (UNII: 0RE8K4LNJS)
lanolin (UNII: 7EV65EAW6H)
light mineral oil (UNII: N6K5787QVP)
methylparaben (UNII: A2I8C7HI9T)
octyldodecanol (UNII: 461N1O614Y)
oleyl alcohol (UNII: 172F2WN8DV)
paraffin (UNII: I9O0E3H2ZE)
phenyl trimethicone (UNII: DR0K5NOJ4R)
propylparaben (UNII: Z8IX2SC1OH)
titanium dioxide (UNII: 15FIX9V2JP)
white wax (UNII: 7G1J5DA97F)

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0573-1900-24	1 in 1 BLISTER PACK	01/01/2004	06/28/2018
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	part347	01/01/2004	06/28/2018

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

Revised: 4/2021

Document Id: d6a0b75a-b099-469e-aa2a-18adab571852

Set id: ece666c8-5b5f-9a2e-aa8c-fa4484a96761

Version: 4

Effective Time: 20210420

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

ChapStick Classic OriginalChapStick Classic CherryChapStick Classic StrawberryChapStick Classic Spearmint(padimate O and white petrolatum)