Otc - Active Ingredient
Active Ingredients:
Avobenzone 2.0%
Octinoxate 6.5%
Octisalate 5.0%
Octocrylene 1.5%
Lip Balm Spf 15 Lipstick
FDA Label NDC 83657-600
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Skin Script, Llc for the product Lip Balm Spf 15 (NDC 83657-600). 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, otc - purpose, indications & usage, otc - questions, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose:
Sunscreen
Indications & Usage
Uses
- Helps prevent sunburn
Otc - Questions
Dist. by: Skin ScriptTM Chandler, AZ 85226
Warnings
Warnings
- For External Use Only
- Do not use on damaged or broken skin
- Stop and ask a doctor if
- rash occurs
- 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.
Dosage & Administration
Directions
- apply liberally 15 minutes before sun exposure
- Use a water resistant sunscreen if swimming or sweating
- Reapply at least every 2 hours
- Children under 6 months of age: Ask a doctor
- limit time in the sun, especially from 10a.m. - 2p.m.
- wear long sleeved shirts, pants, hats, and sunglasses.
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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
Inactive Ingredient
Inactive Ingredients:
Sunflower Oil*, Beeswax, Olive Oil*, Flavor, Tocopherol, Hemp Seed Oil*, Rosemary Extract, Aloe Extract, Soybean Oil, Sunflower Seed Oil Glycerides, Canola Oil. *Organic
Other Safety Information
Other Information
Protect this product from excessive heat and direct sun.
Recent Major Changes
Corrected Indications and usage section
* Please review the disclaimer below.
