CHAPSTICK- avobenzone, octinoxate, and white petrolatum 
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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Drug Facts

Moisturizer | 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 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
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 (Classic 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 dioxide, white wax, yellow 5 lake

Inactive Ingredients (Classic 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 (Classic 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

Additional Information

Paraben 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

PRINCIPAL DISPLAY PANEL

NDC 0573-2028-01

ChapStick®

PUT YOUR LIPS FIRST®

8 HOUR MOISTURE

SPF15

9 Classic Cherry/Skin Protectant
9 Classic Original/Skin Protectant
9 Classic Strawberry/Skin Protectant
9 Moisturizer Original Skin/Sunscreen/Broad Spectrum SPF 15

NET WT 0.15 OZ
(4 g) EACH

36 INDIVIDUAL STICKS

PAA171900 – Front Carton

Chapstick Fishbowl 36 ct
CHAPSTICK 
avobenzone, octinoxate, and white petrolatum kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-2028
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-2028-011 in 1 PACKAGE; Type 0: Not a Combination Product06/28/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 19 CYLINDER 36 g
Part 29 CYLINDER 36 g
Part 39 CYLINDER 36 g
Part 49 CYLINDER 36 g
Part 1 of 4
CHAPSTICK MOISTURIZER ORIGINAL 
avobenzone, octinoxate, and white petrolatum stick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM423 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ISOCETYL STEARATE (UNII: 3RJ7186O9W)  
LANOLIN (UNII: 7EV65EAW6H)  
MINERAL OIL (UNII: T5L8T28FGP)  
PARAFFIN (UNII: I9O0E3H2ZE)  
SACCHARIN (UNII: FST467XS7D)  
.ALPHA.-TOCOPHEROL LINOLEATE, D- (UNII: G0N132Q0ED)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WHITE WAX (UNII: 7G1J5DA97F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 g in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/28/2021
Part 2 of 4
CHAPSTICK CLASSIC STRAWBERRY 
white petrolatum stick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM450 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 (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    Score    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 g in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/28/2021
Part 3 of 4
CHAPSTICK CLASSIC CHERRY 
white petrolatum stick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM450 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 g in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/30/2021
Part 4 of 4
CHAPSTICK CLASSIC ORIGINAL 
white petrolatum stick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM450 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 g in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/28/2021
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 6/2021
Document Id: 72ee5f30-81cb-42d4-8165-951548a4fbb3
Set id: 72ee5f30-81cb-42d4-8165-951548a4fbb3
Version: 1
Effective Time: 20210618
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC