Otc - Active Ingredient
Active ingredients
Avobenzone 3%, Octinoxate 7.5%, Octisalate 5%, Octocrylene 5%
Peppermint Spf 15 Sunscreen Lip Balm Stick
FDA Label NDC 84489-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Naples Soap Company, Inc. for the product Peppermint Spf 15 Sunscreen Lip Balm (NDC 84489-101). 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, warnings, otc - do not use, otc - when using, otc - stop use, 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
Otc - Purpose
Purpose:
Sunscreen
Indications & Usage
Use helps prevent sunburn
Warnings
Warnings
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - When Using
When using this product, keep out of eyes
Otc - Stop Use
Stop use and ask a doctor if rash occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Dosage & Administration
Directions
- apply liberally 15 minutes before sun exposure
- reapply at least every 2 hours
- use a water resistance sunscreen if swimming or sweating
- 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:
- limit time in the sun, especially from 10 a.m.-2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
- children under 6 months of age: ask a doctor
Storage And Handling
Other informationprotect this product from excessive heat and direct sun
Inactive Ingredient
Inactive ingredients
Helianthus Annuus (Sunflower) Seed Oil*, Cera Flava (Beeswax)*, Theobroma Cacao (Cocoa) Seed Butter*, Cocos Nucifera (Coconut) Oil*, Essential Oil of Mentha Piperita (Peppermint) Leaf Oil*, Aloe Barbadensis (Aloe Vera) Leaf Oil*, Mixed Tocopherols (Vitamin E), Rosmarinus Officinalis (Rosemary) Leaf Extract*, Calendula Officinalis (Calendula) Flower Extract*. *Organic Ingredient
Otc - Questions
Questions or comments?
Questions? 1-888-256-8265 or visit www.naplessoap.com
Other
NAPLES
SOAP COMPANY
SUNSCREEN
Broad spectrum SPF 15
-15-
Lip Balm
.15 oz / 4.25 g
Peppermint
Distributed by: Naples Soap Company
Fort Myers, FL 33913
naplessoap.com - (239) 325-8263
Made in USA from
foreign & domestic parts - 84489
Package Label.Principal Display Panel
Net Wt. 0.15 oz (4.25 g)
* Please review the disclaimer below.
