drug facts

drug facts
SPL v5
SPL
SPL Set ID 9cd13fbb-887f-46a8-9f0b-4450ad3e07b7
Route
topical
Published
Effective Date 2020-11-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) octinoxate (75 mg) petrolatum (423 mg)
Inactive Ingredients
aloe vera leaf carnauba wax cetyl alcohol .alpha.-tocopherol linoleate, d- isocetyl stearate lanolin mineral oil paraffin saccharin .alpha.-tocopherol acetate white wax

Identifiers & Packaging

Pill Appearance
Shape: bullet Color: yellow Size: 42 mm
Marketing Status
otc monograph drug active Since 2018-06-28

Purpose

Sunscreens Skin protectant

Description

Avobenzone 3% Octinoxate 7.5% White petrolatum 42.3%


Medication Information

Warnings

For external use only

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
Purpose

Sunscreens Skin protectant

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:
    • o
      Limit time in the sun, especially from 10 a.m. – 2 p.m.
    • o
      Wear long-sleeved shirts, pants, hats, and sunglasses
Other Information
  • store at 20-25°C (68-77°F)
  • protect the 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

Description

Avobenzone 3% Octinoxate 7.5% White petrolatum 42.3%

Principal Display Panel

NEW

Improved

Formula

BRAND LIP CARE

ChapStick®

SKIN PROTECTANT | SUNSCREEN

BROAD SPECTRUM SPF 15

MOISTURIZER

2 in 1 Lipcare

8

HOUR

MOISTURE

SPF 15

Original

NET WT 0.15 OZ (4 g)

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

Active Ingredients

Avobenzone 3%

Octinoxate 7.5%

White petrolatum 42.3%

Additional Information

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

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

Trademarks are owned by or licensed to the

GSK group of companies.

©2023 GSK or licensor.

Paraben Free

Moisturizer Original

Questions Or Comments?

call weekdays from 8 AM to 6 PM EST at 1-800-245-1040


Structured Label Content

Warnings

For external use only

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
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:
    • o
      Limit time in the sun, especially from 10 a.m. – 2 p.m.
    • o
      Wear long-sleeved shirts, pants, hats, and sunglasses
Other Information (Other information)
  • store at 20-25°C (68-77°F)
  • protect the product from excessive heat and direct sun
Inactive Ingredients (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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NEW

Improved

Formula

BRAND LIP CARE

ChapStick®

SKIN PROTECTANT | SUNSCREEN

BROAD SPECTRUM SPF 15

MOISTURIZER

2 in 1 Lipcare

8

HOUR

MOISTURE

SPF 15

Original

NET WT 0.15 OZ (4 g)

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

Active Ingredients (Active ingredients)

Avobenzone 3%

Octinoxate 7.5%

White petrolatum 42.3%

Additional Information (Additional information)

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

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

Trademarks are owned by or licensed to the

GSK group of companies.

©2023 GSK or licensor.

Paraben Free

Moisturizer Original

Questions Or Comments? (Questions or comments?)

call weekdays from 8 AM to 6 PM EST at 1-800-245-1040


Advanced Ingredient Data


Raw Label Data

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