FDA Label for Chapstick

View Indications, Usage & Precautions

Chapstick Product Label

The following document was submitted to the FDA by the labeler of this product Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

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

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?

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

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

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

* Please review the disclaimer below.

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