Active Ingredients
Avobenzone 2.7%, Octisalate 4.5%, Octocrylene 9.0%
Hawaiian Tropic Oil
FDA Label NDC 63354-784
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 63354-784). 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 on, 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
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 with a broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses • children under 6 months: Ask a doctor
Inactive Ingredients
Mineral Oil, Diisopropyl Adipate, Isopropyl Myristate, Butyloctyl Salicylate, Silica, Fragrance, Cocos Nucifera (Coconut) Oil, Polybutene, Theobroma Cacao (Cocoa) Seed Butter, Glycine Soja (Soybean) Oil, Tocopheryl Acetate, Zea Mays (Corn) Oil, Tartaric Acid, Phenyl Trimethicone, Histidine, Arginine, Ascorbyl Palmitate, Daucus Carota Sativa (Carrot) Root Extract, Glyceryl Oleate, Beta-Carotene, Aloe Barbadensis Leaf Extract, Psidium Guajava Fruit Extract, Plumeria Acutifolia Flower Extract, Passiflora Incarnata Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Red 17, Yellow 11.
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®
SUNSCREEN OIL SPRAY
PROTECTIVE
TANNING
ENHANCE TAN & MOISTURIZE
COCONUT OIL
25
CRUELTY FREE | VEGAN
BROAD SPECTRUM SPF 25 UVA / UVB
WATER RESISTANT (80 MINUTES)
8 FL. OZ (236 mL)
* Please review the disclaimer below.
