Active Ingredients
Avobenzone 3.0%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 6.5%
Hawaiian Tropic Lotion
FDA Label NDC 63354-199
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 (NDC 63354-199). 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 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 Agent
Uses
• helps prevent sunburn • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
Warnings
For external use only
May stain some fabrics and surfaces.
Do Not Use
on damaged or broken skin
When Using This Product
keep out of eyes. Rinse with water to remove.
Stop 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 two hours • 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 Ingredients
Water, Silica, Propylene Glycol, Cetyl Dimethicone, Phenoxyethanol, Mica, Sodium Polyacrylate, Acrylates/C12-22 Alkyl
Methacrylate Copolymer, Caprylyl Glycol, Fragrance, Chlorphenesin, Glycerin, Disodium EDTA, Aloe Barbadensis Leaf Juice, Sodium
Hyaluronate, Hibiscus Sabdariffa Flower Extract, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Titanium Dioxide
Other Information
protect this product from excessive heat and direct sun
Questions Or Comments?
Call 1-800-NO UV RAY, Mon-Fri
Principal Display Panel
HAWAIIAN
TROPIC(R)
INVISIBLE SUNSCREEN
SHEER TOUCH
SERUM
LEAVES SKIN RADIANT
HYALURONIC ACID
50
CRUELTY FREE | VEGAN
BROAD SPECTRUM SPF 50 UVA/UVB
3.3 FL. OZ (97 mL)
Label (Label)
* Please review the disclaimer below.
