Chapstick
FDA Label NDC 0573-2028

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Glaxosmithkline Consumer Healthcare Holdings (us) Llc for the product Chapstick (NDC 0573-2028). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purposes, uses, warnings, otc - do not use, otc - stop use, otc - when using, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Avobenzone 3%

Octinoxate 7.5%

White petrolatum 42.3%

Purposes

Sunscreens

Skin protectant

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
    • ▪helps prevent and temporarily protects chafed, chapped or cracked lips
    • ▪helps prevent and protect from the drying effects of wind and cold weather

Warnings

For external use only

For external use only

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - Stop Use

Stop use and ask a doctor if rash occurs

Otc - When Using

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

Otc - Keep Out Of Reach Of Children

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

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:
    • ▪limited time in the sun, especially from 10 a.m. – 2 p.m.
    • ▪wear long-sleeved shirts, pants, hats, and sunglasses

      • apply as needed

Other Information

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

    • store at 20-25°C (68-77°F)

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

Questions Or Comments?

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Active Ingredient

White petrolatum 45%

Purpose

Skin Protectant

Inactive Ingredients (Classic Original)

arachidyl propionate, camphor, carnauba wax, cetyl alcohol, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, octyldodecanol, oleyl alcohol, paraffin, phenyl trimethicone, red 6 lake, titanium dioxide, white wax, yellow 5 lake

Inactive Ingredients (Classic Cherry)

arachidyl propionate, camphor, carnauba wax, cetyl alcohol, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, menthol, octyldodecanol, paraffin, phenyl trimethicone, red 6 lake, saccharin, white wax

Inactive Ingredients (Classic Strawberry)

arachidyl propionate, camphor, carnauba wax, cetyl alcohol, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, lemon oil, light mineral oil, maltol, octyldodecanol, paraffin, phenyl trimethicone, red 6 lake, saccharin, white wax

Additional Information

Paraben Free

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

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

Trademarks owned or licensed by GSK ©2021 GSK or licensor

Principal Display Panel

NDC 0573-2028-01

ChapStick®

PUT YOUR LIPS FIRST®

8 HOUR MOISTURE

SPF15

  • 9 Classic Cherry/Skin Protectant
  • 9 Classic Original/Skin Protectant
  • 9 Classic Strawberry/Skin Protectant
  • 9 Moisturizer Original Skin/Sunscreen/Broad Spectrum SPF 15

    • NET WT 0.15 OZ
    (4 g) EACH

    36 INDIVIDUAL STICKS

    PAA171900 – Front Carton

    Chapstick Fishbowl 36 Ct (Image 01)

    Chapstick Fishbowl 36 Ct (Image 01)

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