Active Ingredient
Avobenzone 3.0%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 9.0%
Hawaiian Tropic Stick
FDA Label NDC 63354-791
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 63354-791). 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 ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, 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.
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 ■ 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.
Other Information
■ protect this product in this container from excessive heat and direct sun ■ May stain some fabrics and surfaces
Inactive Ingredients
Mineral Oil, Octyldodecanol, Hydroxystearic Acid, Butyloctyl Salicylate, Dibutyl Lauroyl Glutamide, Dibutyl Ethylhexanoyl Glutamide, Silica Cetyl Silylate, Silica Dimethicone Silylate, Stearic Acid, Fragrance, Palmitic Acid, Caprylic/Capric Triglyceride, Synthetic fluorphlogopite, Hibiscus Sabdariffa Seed Oil, Ethylhexyl Palmitate, Silica, Camellia Sinensis Leaf Extract, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Iron Oxides.
Questions?
Call 1-800-NO UV RAY, Mon-Fri
Principal Display Panel
HAWAIIAN
TROPIC®
SUNSCREEN STICK
SHIMMER BALM
HYDRATED RADIANT SKIN
GOES ON CLEAR
50
WON'T CLOG PORES | VEGAN
BROAD SPECTRUM SPF 50 UVA/UVB
NET WT. 0.6 OZ (17 g)
Label (63354 791 61 Label)
HAWAIIAN
TROPIC®
SUNSCREEN STICK
SHIMMER BALM
HYDRATED RADIANT SKIN
GOES ON CLEAR
50
WON'T CLOG PORES | VEGAN
BROAD SPECTRUM SPF 50 UVA/UVB
NET WT. 0.6 OZ (17 g)
Carton (63354 791 61 Carton)
* Please review the disclaimer below.
