Otc - Active Ingredient
Active Ingredients: Purpose: Sunscreen
Avobenzone (2.0%)
Octinoxate (6.5%)
Octisalate (5.0%)
Octocrylene (1.5%)
Skin Crave Spf15 Lip Balm
FDA Label NDC 58418-295
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 Skin Crave Spf15 Lip Balm (NDC 58418-295). 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, dosage & administration, inactive ingredient, otc - keep out of reach of children, otc - purpose, warnings, indications & usage, 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
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: Ask a doctor.
Inactive Ingredient
Inactive Ingredients: Sunflower oil, beeswax, extra virgin olive oil, flavor, hemp seed oil, rosemaruy extract, vitamin E, aloe vera
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.
Otc - Purpose
Purpose: Sunscreen
Warnings
Warnings:
-Skin Cancer/Skin Aging Alert: Spending time in the sun increases yuour risk of skin cancer and early aging. Thois product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
-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.
Indications & Usage
Uses: Helps prevent sunburn
* Please review the disclaimer below.
