Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 33497c07-ad6e-4c50-bc23-a55725b2eae1
Route
TOPICAL
Published
Effective Date 2022-02-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (40 mg) Octisalate (45 mg) Octocrylene (26 mg) Petrolatum (369 mg)
Inactive Ingredients
Aloe Vera Leaf Benzyl Alcohol Butylated Hydroxytoluene Cetyl Alcohol Carnauba Wax Isocetyl Stearate Lanolin Mineral Oil Myristyl Alcohol Paraffin Stearyl Alcohol Tocopherol .alpha.-tocopherol Acetate White Wax

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-01

Description

Avobenzone 3.0% Homosalate 4.0% Octisalate 4.5% Octocrylene 2.6% White Petrolatum 36.9%

Purpose

Sunscreens Skin protectant


Medication Information

Purpose

Sunscreens Skin protectant

Description

Avobenzone 3.0% Homosalate 4.0% Octisalate 4.5% Octocrylene 2.6% White Petrolatum 36.9%

Uses
  • helps prevent sunburn
  • helps prevent and temporarily protects chafed, chapped or cracked lips
  • helps prevent and protect from the drying effects of wind and cold weather
Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin

Purposes

Sunscreens

Skin protectant

Warnings

Skin Cancer/ Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and

early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or

early skin aging.

For external use only

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
Other Information
  • store at 20-25°C (68-77°F)
  • protect this product from excessive heat and direct sun
Active Ingredients

Avobenzone 3.0%

Homosalate 4.0%

Octisalate 4.5%

Octocrylene 2.6%

White Petrolatum 36.9%

Inactive Ingredients

aloe barbadensis leaf extract, benzyl alcohol, BHT, cetyl alcohol, copernicia cerifera (carnauba) wax, flavor, isocetyl stearate, isopropyl lanolate, lanolin, mineral oil, myristyl alcohol, paraffin, stearyl alcohol, tocopherol, tocopheryl acetate, tocopheryl linoleate/oleate, white beeswax

Additional Information

Paraben Free

Dist by: GSK CH, Warren, NJ 07059

For most recent product information,

visit www.chapstick.com

Trademarks owned or licensed by GSK.

©2022 GSK or licensor

Questions Or Comments?

call weekdays from 9 AM to 6 PM EST at

1-800-245-1040

Principal Display Panel

NEW Formula

BRAND LIP CARE

ChapStick®

SKIN PROTECTANT | SUNSCREEN

SPF 12

MOISTURIZER

2 in 1 Lipcare Cool Mint

8 HOUR MOISTURE

SPF 12

3 STICKS

NET WT 0.15 OZ

(4 g) EACH

000073771


Structured Label Content

Uses
  • helps prevent sunburn
  • helps prevent and temporarily protects chafed, chapped or cracked lips
  • helps prevent and protect from the drying effects of wind and cold weather
Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Purposes

Sunscreens

Skin protectant

Warnings

Skin Cancer/ Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and

early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or

early skin aging.

For external use only

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
Other Information (Other information)
  • store at 20-25°C (68-77°F)
  • protect this product from excessive heat and direct sun
Active Ingredients (Active ingredients)

Avobenzone 3.0%

Homosalate 4.0%

Octisalate 4.5%

Octocrylene 2.6%

White Petrolatum 36.9%

Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf extract, benzyl alcohol, BHT, cetyl alcohol, copernicia cerifera (carnauba) wax, flavor, isocetyl stearate, isopropyl lanolate, lanolin, mineral oil, myristyl alcohol, paraffin, stearyl alcohol, tocopherol, tocopheryl acetate, tocopheryl linoleate/oleate, white beeswax

Additional Information (Additional information)

Paraben Free

Dist by: GSK CH, Warren, NJ 07059

For most recent product information,

visit www.chapstick.com

Trademarks owned or licensed by GSK.

©2022 GSK or licensor

Questions Or Comments? (Questions or comments?)

call weekdays from 9 AM to 6 PM EST at

1-800-245-1040

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NEW Formula

BRAND LIP CARE

ChapStick®

SKIN PROTECTANT | SUNSCREEN

SPF 12

MOISTURIZER

2 in 1 Lipcare Cool Mint

8 HOUR MOISTURE

SPF 12

3 STICKS

NET WT 0.15 OZ

(4 g) EACH

000073771


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)