Active Ingredients
Avobenzone 3.0%, Octisalate 5.0%, Octocrylene 10.0%
Hawaiian Tropic Lip Balm Sunscreen Spf 30 Stick
FDA Label NDC 63354-520
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Edgewell Personal Care Brands Llc for the product Hawaiian Tropic Lip Balm Sunscreen Spf 30 (NDC 63354-520). 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 active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Uses
• helps prevent sunburn.
Warnings
• For external use only.
May stain some fabrics.
Do Not Use
on damaged or broken skin.
When Using This Product
keep out of eyes. Rinse with water to remove.
Stop Use And Ask A Doctor
if rash occurs.
Keep Out Of Reach Of Children.
If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
• apply liberally 15 minutes before sun exposure • reapply: after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • reapply after eating or drinking • Children under 6 months: 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 10 a.m. - 2 p.m., wear long-sleeved shirts, pants, hats, and sunglasses. •Children under 6 months: Ask a doctor
Inactive Ingredient
Caprylic/Capric Triglyceride, Ozokerite, Petrolatum, Ethylhexyl Palmitate, VP/Eicosene Copolymer, Butyloctyl Salicylate, Flavor, PEG-8, Oryza Sativa (Rice) Bran Wax, Sodium Saccharin, Tocopheryl Acetate.
Other Information
• protect this product from excessive heat and direct sun.
Questions / Comments
1-800-NO UV RAY
Principal Display Panel
TROPICAL flavor
SPF
30
HAWAIIAN TROPIC(R)
LIP BALM
Sunscreen Stick
Water Resistant (80 minutes)
OXYBENZONE &
OCTINOXATE FREE
MOISTURIZES
FOR 12 HOURS
(R)
0.14 OZ (4.25g)
* Please review the disclaimer below.
