Other
UVA/UVB BROAD SPECTRUM SPF 15
Spearmint Sunscreen Lip Balm
Coconut Sunscreen Lip Balm
Spf 15 Spearmint Lip Balm Stick
FDA Label NDC 84489-269
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 Spf 15 Spearmint Lip Balm (NDC 84489-269). 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 other, active ingredient, purpose, uses, warnings, otc - do not use, otc - stop use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Zinc Oxide 3.5%
Purpose
Sunscreen
Uses
- Helps prevent sunburn
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
- 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 10 a.m. - 2 p.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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
Other Information
- Protect this product from excessive heat and direct sun
Inactive Ingredients
Organic Calendula, Organic Comfrey, Organic Lavender, Organic Plantain and Organic Yarrow Infused in Organic Extra Virgin Olive Oil with Organic Beeswax, Organic Coconut Flavor and Non-GMO Vitamin E.
Package Label.Principal Display Panel
NAPLES SOAP COMPANY
SPF 15
Spearmint Lip Balm
NET WT 0.15 OZ (4.2 g)
Spf 15 Spearmint Lip Balm Label (Eh Agl Spearmint Spf15 07 24 For Fda)
NAPLES SOAP COMPANY
SPF 15
Coconut Lip Balm
NET WT 0.15 OZ (4.2 g)
Spf 15 Coconut Lip Balm Label (Eh Agl Coconut Spf15 121521 Cobrandtemplate Ol For Fda)
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