Otc - Active Ingredient
Drug Facts
Active Ingredients:
Avobenzone 2.0%
Octinoxate 6.5%
Octisalate 5.0%
Octocrylene 1.5%
Wildberry Lip Balm Stick
FDA Label NDC 71087-114
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Casad Company Inc. for the product Wildberry Lip Balm (NDC 71087-114). 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 and precautions, otc - keep out of reach of children, dosage & administration, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Avobenzone ,,,,Sunscreen
Octinoxate ,,,,,,,Sunscreen
Octisalate ,,,,,,,,Sunscreen
Octocrylene ,,,,,Sunscreen
Indications & Usage
Uses: Helps prevent sunburn
Warnings And Precautions
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children: If swallowed, get medilcal
help or contact a Poison Control center right away.
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 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 protection measures including: • limit time in the sun, especially from
10a.m. - 2p.m.• wear long sleeved shirts, pants, hat, and sunglasses
Inactive Ingredient
Inactive ingredients: Sunflower oil, beeswax, extra virgin olive
oil, flavor, hemp seed oil, rosemary extract, vitamin E, aloe vera.
Other Safety Information
Other Information:
Protect this product from excessive heat and direct sun.
Package Label.Principal Display Panel
Broad Spectrum SPF 15 Sunscreen
Wildberry Lip Balm
Net Wt. 0.15 oz (4.25g)
SAFETY SEAL
Dist. by:www.totallypromotional.com | CoIdwater, OH 45828
Vanilla Mint (71087 114)
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