Otc - Active Ingredient
Avobenzone 3%
Homosalate 7.5%
Octisalate 5%
Octocrylene 2.5%
Oxybenzone 6%
Rr Spf30 Sun Stick
FDA Label NDC 58418-276
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tropical Enterprises International, Inc for the product Rr Spf30 Sun Stick (NDC 58418-276). 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, instructions for use, warnings, inactive ingredient, other safety information, 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
Instructions For Use
Uses - Helps prevent sunburn
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 10am - 2pm.
- 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:
Warnings
- For external use only
- Do not use on damaged or broken skin
- Stop use and ask a doctor if 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.
Inactive Ingredient
Beeswax, cetyl alcohol, cocoa butter, coconut oil, dimethicone, jojoba oil, ozokerite wax, rosemary extract, vitamin E
Other Safety Information
Other Information:
Protect this product from excessive heat and direct sun.
Package Label.Principal Display Panel
Bsspf30sunstick (58418 273)
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