CHAPSTICK- avobenzone, octinoxate, and white petrolatum kit

Chapstick by

Drug Labeling and Warnings

Chapstick by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Moisturizer 2 in 1 Lip Care | Original

Active ingredients

Avobenzone 3%

Octinoxate 7.5%

White petrolatum 42.3%

Purposes

Sunscreens

Skin protectant

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
• helps prevent and temporarily protects chafed, chapped or cracked lips
• helps prevent and protect from the drying effects of wind and cold weather

Warnings

For external use only

Do not useon damaged or broken skin

Stop use and ask a doctor ifrash occurs

When using this productkeep 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
• Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limited time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses

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, carnauba wax, cetyl alcohol, fragrance, isocetyl stearate, isopropyl lanolate, lanolin, mineral oil, paraffin, saccharin, tocopheryl linoleate/oleate, vitamin E acetate, white wax

Questions or Comments?

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

Classic | Original . Cherry . Strawberry

Active ingredient

White petrolatum 45%

Purpose

Skin protectant

Uses

• helps prevent and temporarily protects chafed, chapped or cracked lips
• helps prevent and protect from the drying effects of wind and cold weather

Warnings

For external use only

Keep Out of Reach of Children

Directions

Apply as needed

Other Information

store at 20-25°C (68-77°F)

Inactive ingredients (Original)

arachidyl propionate, camphor, carnauba wax, cetyl alcohol, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, octyldodecanol, oleyl alcohol, paraffin, phenyl trimethicone, red 6 lake, titanium, white wax, yellow 5 lake

Inactive ingredients (Cherry)

arachidyl propionate, camphor, carnauba wax, cetyl alcohol, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, menthol, octyldodecanol, paraffin, phenyl trimethicone, red 6 lake, saccharin, white wax

Inactive ingredients (Strawberry)

arachidyl propionate, camphor, carnauba wax, cetyl alcohol, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, lemon oil, light mineral oil, maltol, octyldodecanol, paraffin, phenyl trimethicone, red 6 lake, saccharin, white wax

Chapstick total hydration Eucalyptus Mint

Ingredients:

helianthus annuus (sunflower) seed oil, jojoba esters, euphorbia cerifera (candelilla) wax, cocos nucifera (coconut) oil, beeswax, caprylic/capric triglyceride, copernicia cerifera (carnauba) wax,

argania spinosa (argan) kernel oil, flavor, tocopheryl acetate, carthamus tinctorius (safflower) seed oil, mangifera indica (mango) seed butter, butyrospermum parkii (shea) butter, octyldodecanol, persea gratissima (avocado) oil, olea europaea (olive) fruit oil, tocopherol, hydrogenated soybean oil, aloe barbadensis leaf extract, rubus idaeus (raspberry) seed oil, glyceryl stearate

Other information

store at 20-25°C (68-77°F).

Chapstick total hydration Soothing Vanilla

Ingredients:

helianthus annuus (sunflower) seed oil, jojoba esters, euphorbia cerifera (candelilla) wax, cocos nucifera (coconut) oil, beeswax, caprylic/capric triglyceride, copernicia cerifera (carnauba) wax,

argania spinosa (argan) kernel oil, flavor, tocopheryl acetate, carthamus tinctorius (safflower) seed oil, mangifera indica (mango) seed butter, butyrospermum parkii (shea) butter, octyldodecanol, persea gratissima (avocado) oil, olea europaea (olive) fruit oil, tocopherol, hydrogenated soybean oil, aloe barbadensis leaf extract, rubus idaeus (raspberry) seed oil, glyceryl stearate

Other information

store at 20-25°C (68-77°F).

Additional Information

Paraben Free . Cruelty Free

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

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

Trademarks owned or licensed by GSK ©2021 GSK or licensor

Patents: www.productspats.com

PRINCIPAL DISPLAY PANEL

NDC: 0573-2027-01

ChapStick ®

PUT YOUR LIPS FIRST®

1 EUCALYPTUS MINT

1 SOOTHING VANILLA

• *100% naturally sourced ingredients
• Age defying formula with argan oil and avocado butters
• Contains omegas 6 & 9

2 MOISTURIZER ORIGINAL
SKIN PROTECTANT / SUNSCREEN
BROAD SPECTRUM SPF 15

SPF 15

2 CLASSIC STRAWBERRY
SKIN PROTECTANT

3 CLASSIC CHERRY
SKIN PROTECTANT

Paraben Free

Cruelty Free

3 CLASSIC ORIGINAL
SKIN PROTECTANT

12 INDIVIDUAL STICKS
TOTAL HYDRATION

-2 STICKS
NET WT 0.12 OZ
(3.5g) EACH

MOISTURIZER
-2 STICKS
NET WT 0.15 OZ
(4g) EACH

CLASSIC
-8 STICKS
NET WT 0.15 OZ
(4g) EACH

PAA166168 – Front

INGREDIENTS AND APPEARANCE

CHAPSTICK 
avobenzone, octinoxate, and white petrolatum kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0573-2027

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-2027-01	1 in 1 PACKAGE; Type 0: Not a Combination Product	04/28/2021

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	2 CYLINDER	8 g
Part 2	2 CYLINDER	8 g
Part 3	3 CYLINDER	12 g
Part 4	3 CYLINDER	12 g
Part 5	1 CYLINDER	3.5 g
Part 6	1 CYLINDER	3.5 g

Part 1 of 6

CHAPSTICK MOISTURIZER ORIGINAL 
avobenzone, octinoxate, and white petrolatum stick

Product Information
Item Code (Source)	NDC: 0573-0725
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
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	423 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CETYL ALCOHOL (UNII: 936JST6JCN)
.ALPHA.-TOCOPHEROL LINOLEATE, D- (UNII: G0N132Q0ED)
ISOCETYL STEARATE (UNII: 3RJ7186O9W)
LANOLIN (UNII: 7EV65EAW6H)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
SACCHARIN (UNII: FST467XS7D)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WHITE WAX (UNII: 7G1J5DA97F)

Product Characteristics
Color	yellow	Score
Shape	BULLET	Size	42mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-0725-12	1 in 1 BLISTER PACK
1		4 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	347	04/30/2021

Part 2 of 6

CHAPSTICK CLASSIC STRAWBERRY 
white petrolatum stick

Product Information
Item Code (Source)	NDC: 0573-0715
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	450 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ARACHIDYL PROPIONATE (UNII: QV5DAH3MSB)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CETYL ALCOHOL (UNII: 936JST6JCN)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LANOLIN (UNII: 7EV65EAW6H)
LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
MALTOL (UNII: 3A9RD92BS4)
OCTYLDODECANOL (UNII: 461N1O614Y)
PARAFFIN (UNII: I9O0E3H2ZE)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
D&C RED NO. 6 (UNII: 481744AI4O)
SACCHARIN (UNII: FST467XS7D)
WHITE WAX (UNII: 7G1J5DA97F)

Product Characteristics
Color	red	Score
Shape	BULLET	Size	42mm
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-0715-12	1 in 1 BLISTER PACK
1		4 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	04/30/2021

Part 3 of 6

CHAPSTICK CLASSIC CHERRY 
white petrolatum stick

Product Information
Item Code (Source)	NDC: 0573-0705
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	450 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ARACHIDYL PROPIONATE (UNII: QV5DAH3MSB)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CETYL ALCOHOL (UNII: 936JST6JCN)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LANOLIN (UNII: 7EV65EAW6H)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
LEVOMENTHOL (UNII: BZ1R15MTK7)
OCTYLDODECANOL (UNII: 461N1O614Y)
PARAFFIN (UNII: I9O0E3H2ZE)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
D&C RED NO. 6 (UNII: 481744AI4O)
SACCHARIN (UNII: FST467XS7D)
WHITE WAX (UNII: 7G1J5DA97F)

Product Characteristics
Color	pink	Score	no score
Shape	BULLET	Size	42mm
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-0705-12	1 in 1 BLISTER PACK
1		4 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	04/30/2021

Part 4 of 6

CHAPSTICK CLASSIC ORIGINAL 
white petrolatum stick

Product Information
Item Code (Source)	NDC: 0573-0701
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	450 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ARACHIDYL PROPIONATE (UNII: QV5DAH3MSB)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CETYL ALCOHOL (UNII: 936JST6JCN)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LANOLIN (UNII: 7EV65EAW6H)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
OCTYLDODECANOL (UNII: 461N1O614Y)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
PARAFFIN (UNII: I9O0E3H2ZE)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
D&C RED NO. 6 (UNII: 481744AI4O)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WHITE WAX (UNII: 7G1J5DA97F)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	pink	Score
Shape	BULLET	Size	42mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-0701-12	1 in 1 BLISTER PACK
1		4 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	04/30/2021

Part 5 of 6

CHAPSTICK TOTAL HYDRATION  EUCALYPTUS MINT
lipsticks and lip glosses [makeup preparations (not eye)(other than makeup preparations for children)]

Product Information
Route of Administration	TOPICAL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		3.5 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		04/30/2021

Part 6 of 6

CHAPSTICK TOTAL HYDRATION  SOOTHING VANILLA
lipsticks and lip glosses [makeup preparations (not eye)(other than makeup preparations for children)]

Product Information
Route of Administration	ORAL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		3.5 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		04/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	04/28/2021

Labeler - Haleon US Holdings LLC (079944263)