CHAPSTICK MOISTURIZER ORIGINAL SPF 15- spf 15 skin protectant stick

ChapStick Moisturizer Original SPF 15 by

Drug Labeling and Warnings

ChapStick Moisturizer Original SPF 15 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]

ACTIVE INGREDIENT

Active Ingredients

Avobenzone

Octinoxate

White Petrolatum

INACTIVE INGREDIENT

Inactive Ingredients: paraffin, isocetyl stearate, beeswax, isopropyl lanolate, tocopherol acetate, lanolin, copernicia cerifera (carnauba) wax, mineral oil, cetyl alcohol, tocopheryl linoleate/oleate, aloe barbadensis leaf extract, flavor, saccharin

PURPOSE

Purposes

Sunscreens

Skin Protectant

INDICATIONS & USAGE

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 lip
• Helps prevent and protect from the drying effects of wind and cold weather

WARNINGS

Warnings

For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if a 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.

KEEP OUT OF REACH OF CHILDREN

Warnings

For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if a 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.

DOSAGE & ADMINISTRATION

Directions

• Apply liberally15 minutes before sun exposure
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating
• Children of 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 decreasing 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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CHAPSTICK MOISTURIZER ORIGINAL SPF 15 
spf 15 skin protectant stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83711-819
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
WHITE PETROLATUM (UNII: B6E5W8RQJ4) (WHITE PETROLATUM - UNII:B6E5W8RQJ4)	WHITE PETROLATUM	42.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FLAVOR SPICE MINT N&A110589 (UNII: KG6KU384XW)
CETYL ALCOHOL (UNII: 936JST6JCN)
BEESWAX (UNII: 2ZA36H0S2V)
ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LANOLIN (UNII: 7EV65EAW6H)
.ALPHA.-TOCOPHEROL LINOLEATE, D- (UNII: G0N132Q0ED)
ISOCETYL STEARATE (UNII: 3RJ7186O9W)
ISOPROPYL LAURATE (UNII: U0JQ94LABM)
COPERNICIA CERIFERA (CARNAUBA) WAX (UNII: R12CBM0EIZ)
PARAFFIN (UNII: I9O0E3H2ZE)
MINERAL OIL (UNII: T5L8T28FGP)
SACCHARIN (UNII: FST467XS7D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83711-819-46	4 g in 1 APPLICATOR; Type 0: Not a Combination Product	01/06/2026
2	NDC: 83711-819-53	4 g in 1 APPLICATOR; Type 0: Not a Combination Product	01/06/2026
3	NDC: 83711-819-54	4 g in 1 APPLICATOR; Type 0: Not a Combination Product	01/06/2026
4	NDC: 83711-819-55	4 g in 1 APPLICATOR; Type 0: Not a Combination Product	01/06/2026
5	NDC: 83711-819-52	4 g in 1 APPLICATOR; Type 0: Not a Combination Product	01/06/2026
6	NDC: 83711-819-56	4 g in 1 APPLICATOR; Type 0: Not a Combination Product	01/06/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/10/2025

Labeler - Suave Brands Co., LLC (118965468)

Establishment
Name	Address	ID/FEI	Business Operations
Autumn Harp, Inc		064187883	manufacture(83711-819)

Establishment
Name	Address	ID/FEI	Business Operations
Fareva Richmond Inc		969523245	pack(83711-819) , manufacture(83711-819)