Otc - Active Ingredient
Active Ingredients:
Avobenzone 3.0%
Octinoxate 6.5%
Octisalate 5.0%
Octocrylene 1.5%
Broad Spectrum Spf 15 Sunscreen Unflavored Lip Balm Stick
FDA Label NDC 65692-0573
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Raining Rose for the product Broad Spectrum Spf 15 Sunscreen Unflavored Lip Balm (NDC 65692-0573). 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, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - keep out of reach of children, route, method and frequency of administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Sunscreen
Warnings
Warnings
For external use only.
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - Ask Doctor
Stop use and ask 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.
Route, Method And Frequency Of Administration
Directions: Apply liberally 15 mintues 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. 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
10a.m. - 2p.m. • wear long sleeved shirts, pants, hats, and sunglasses.
Inactive Ingredient
Inactive Ingredients: Petrolatum, Mineral Oil, Paraffin Wax, Ozokerite Wax, Coconut Oil, Tocopherol, Soybean Oil.
Dosage & Administration
Apply liberally 15 minutes before sun exposure
Indications & Usage
Helps prevent sunburn
* Please review the disclaimer below.
