Otc - Active Ingredient
Active Ingredients
Avobenzone
Octinoxate
White Petrolatum
Chapstick Moisturizer Original Spf 15 Stick
FDA Label NDC 83711-819
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Suave Brands Co., Llc for the product Chapstick Moisturizer Original Spf 15 (NDC 83711-819). 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 otc - active ingredient, inactive ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Inactive Ingredients: paraffin, isocetyl stearate, beeswax, isopropyl lanolate, tocopherol acetate, lanolin, copernicia cerifera (carnauba) wax, mineral oil, cetyl alcohol, tocopheryl linoleate/oleate, aloe barbadensis leaf extract, flavor, saccharin
Otc - Purpose
Purposes
Sunscreens
Skin Protectant
Indications & Usage
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 lip
- Helps prevent and protect from the drying effects of wind and cold weather
Warnings
Warnings
For external use only
Do not use on damaged or broken skin
Stop use and ask a doctor if a rash occurs
When using this product keep out of eyes.
Rinse with water to remove.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Keep Out Of Reach Of Children
Warnings
For external use only
Do not use on damaged or broken skin
Stop use and ask a doctor if a rash occurs
When using this product keep out of eyes.
Rinse with water to remove.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- Apply liberally15 minutes before sun exposure
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating
- Children of 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 decreasing 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
Package Label.Principal Display Panel
* Please review the disclaimer below.
