Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID c1120c7a-1fa8-45a4-8bcf-35d9cc9f2c74
Route
TOPICAL
Published
Effective Date 2020-11-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Octinoxate (75 mg) Petrolatum (414 mg)
Inactive Ingredients
Aloe Vera Leaf Carnauba Wax Cetyl Alcohol .alpha.-tocopherol Linoleate, D- Isocetyl Stearate Lanolin Medium-chain Triglycerides 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

Description

Avobenzone 3% Octinoxate 7.5% White petrolatum 41.4%

Purpose

Sunscreens Skin protectant


Medication Information

Purpose

Sunscreens Skin protectant

Description

Avobenzone 3% Octinoxate 7.5% White petrolatum 41.4%

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
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

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
  • 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
      limited 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 this product from excessive heat and direct sun
Active Ingredients

Avobenzone 3%

Octinoxate 7.5%

White petrolatum 41.4%

Inactive Ingredients

aloe barbadensis leaf extract, artificial flavor, carnauba wax, cetyl alcohol, isocetyl stearate, isopropyl lanolate, lanolin, medium-chain triglycerides, mineral oil, paraffin, saccharin, tocopheryl linoleate/oleate, vitamin E acetate, white wax

Additional Information

Marketed by: Pfizer

Madison, NJ 07940 USA

©2018 Pfizer Inc.

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

Paraben Free

Questions Or Comments?

call weekdays from 9 AM to 5 PM EST at 1-877-227-3421

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

Cool Mint

NET WT

0.15 OZ (4 g)


Structured Label Content

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
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

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
  • 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
      limited 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 this product from excessive heat and direct sun
Active Ingredients

Avobenzone 3%

Octinoxate 7.5%

White petrolatum 41.4%

Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf extract, artificial flavor, carnauba wax, cetyl alcohol, isocetyl stearate, isopropyl lanolate, lanolin, medium-chain triglycerides, mineral oil, paraffin, saccharin, tocopheryl linoleate/oleate, vitamin E acetate, white wax

Additional Information (Additional information)

Marketed by: Pfizer

Madison, NJ 07940 USA

©2018 Pfizer Inc.

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

Paraben Free

Questions Or Comments? (Questions or comments?)

call weekdays from 9 AM to 5 PM EST at 1-877-227-3421

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

Cool Mint

NET WT

0.15 OZ (4 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)