CHAPSTICK CLASSIC VARIETY-CLASSIC CHERRY-CLASSIC STRAWBERRY-CLASSIC SPEARMINT- skin protectant lip balm stick

ChapStick Classic Variety-Classic Cherry-Classic Strawberry-Classic Spearmint by

Drug Labeling and Warnings

ChapStick Classic Variety-Classic Cherry-Classic Strawberry-Classic Spearmint by is a Otc medication manufactured, distributed, or labeled by Suave Brands Co., LLC, Autumn Harp, Inc., Fareva Richmond Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INACTIVE INGREDIENT

Inactive Ingredients:

arachidyl propionate, blue 1 lake, camphor, carnauba wax, cetyl alcohol,fragrance, isopropyl lanolate, isopropyl myristate, lanolin, lemon oil, light mineral oil, maltol, menthol, natural and artificial flavor, octyldodecanol, oleyl alcohol, paraffin, phenyl trimethicone, red 6 lake, saccharin, titanium dioxide, white wax, yellow 5 lake

ACTIVE INGREDIENT

Active Ingredient White Petrolatum

PURPOSE

Purpose Skin Protectant

INDICATIONS & USAGE

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

Warnings

For external use only

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Warnings

For external use only

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions apply as needed

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CHAPSTICK CLASSIC VARIETY-CLASSIC CHERRY-CLASSIC STRAWBERRY-CLASSIC SPEARMINT 
skin protectant lip balm stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83711-817
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WHITE PETROLATUM (UNII: B6E5W8RQJ4) (WHITE PETROLATUM - UNII:B6E5W8RQJ4)	WHITE PETROLATUM	45 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WHITE WAX (UNII: 7G1J5DA97F)
FRAGRANCE 13576 (UNII: 5EM498GW35)
PARAFFIN (UNII: I9O0E3H2ZE)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ARACHIDYL PROPIONATE (UNII: QV5DAH3MSB)
YELLOW 5 (UNII: I753WB2F1M)
LEMON OIL (UNII: I9GRO824LL)
RED 6 (UNII: 481744AI4O)
FLAVOR SPICE MINT N&A110589 (UNII: KG6KU384XW)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
ISOPROPYL LAURATE (UNII: U0JQ94LABM)
MENTHOL (UNII: L7T10EIP3A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
OCTYLDODECANOL (UNII: 461N1O614Y)
LANOLIN (UNII: 7EV65EAW6H)
CETYL ALCOHOL (UNII: 936JST6JCN)
BLUE 1 LAKE (UNII: J9EQA3S2JM)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SACCHARIN (UNII: FST467XS7D)
MALTOL (UNII: 3A9RD92BS4)
OLEYL ALCOHOL (UNII: 172F2WN8DV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83711-817-46	4 g in 1 APPLICATOR; Type 0: Not a Combination Product	04/03/2024
2	NDC: 83711-817-45	4 g in 1 APPLICATOR; Type 0: Not a Combination Product	04/03/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	04/03/2024

Labeler - Suave Brands Co., LLC (118965468)

Establishment
Name	Address	ID/FEI	Business Operations
Autumn Harp, Inc.		064187883	manufacture(83711-817)

Establishment
Name	Address	ID/FEI	Business Operations
Fareva Richmond Inc		969523245	pack(83711-817) , manufacture(83711-817)