Drugplain

Hawaiian Tropic 2 g/100g

AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE · LOTION · Edgewell Personal Care Brands, LLC

1 Recall on Record
Plain English

Hawaiian Tropic is a lotion containing avobenzone,homosalate,octisalate,octocrylene at 2 g/100g, taken topical. Manufactured by Edgewell Personal Care Brands, LLC.

Key Facts

Brand Name
Hawaiian Tropic
Generic Name
AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE
NDC Code (Product)
63354-582
Manufacturer
Edgewell Personal Care Brands, LLC
Strength
2 g/100g
Dosage Form
LOTION
Route
TOPICAL
Marketing Status
Application #
M020
Marketing Start
10/23/2020

Recall History

1 Recall on Record
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective507 reports
macular degeneration453 reports
off label use313 reports
pyrexia303 reports
nausea284 reports
pain281 reports
malaise259 reports
weight decreased235 reports
therapeutic product effect incomplete213 reports
headache201 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

Directions • Shake well • Hold container 4 to 6 inches from the skin to apply • Spray liberally and spread evenly by hand 15 minutes before sun exposure • Do not spray directly into face. Spray on hands and then apply to face. • Do not apply in windy conditions • Use in a well-ventilated area • 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

Warnings

Warnings For external use only Do not use on damaged or broken skin. When using this product keep away from face to avoid breathing it • 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.

Frequently Asked Questions

What is Hawaiian Tropic used for?

Hawaiian Tropic contains AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE. It is a lotion taken topical. Consult your doctor for specific uses.

Is Hawaiian Tropic a controlled substance?

Hawaiian Tropic is not classified as a controlled substance by the DEA.

What is the generic name for Hawaiian Tropic?

The generic name for Hawaiian Tropic is AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE. There are 12 other brand versions of AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE.

What is the NDC code for Hawaiian Tropic 2 g/100g?

The NDC (National Drug Code) for Hawaiian Tropic 2 g/100g is 63354-582, listed by Edgewell Personal Care Brands, LLC.