HAWAIIAN TROPIC 2.7 g/100g

Homosalate,Octocrylene,Octisalate,Avobenzone · STICK · Edgewell Personal Care Brands LLC

1 Recall on Record

Plain English

HAWAIIAN TROPIC is a stick containing homosalate,octocrylene,octisalate,avobenzone at 2.7 g/100g, taken topical. Manufactured by Edgewell Personal Care Brands LLC.

Key Facts

Brand Name: HAWAIIAN TROPIC
Generic Name: Homosalate,Octocrylene,Octisalate,Avobenzone
NDC Code (Product): 63354-861
Manufacturer: Edgewell Personal Care Brands LLC
Strength: 2.7 g/100g
Dosage Form: STICK
Route: TOPICAL
Marketing Status
Application #: M020
Marketing Start: 10/01/2025

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 Homosalate,Octocrylene,Octisalate,Avobenzone. It is a stick 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 Homosalate,Octocrylene,Octisalate,Avobenzone. There are 6 other brand versions of Homosalate,Octocrylene,Octisalate,Avobenzone.

What is the NDC code for HAWAIIAN TROPIC 2.7 g/100g?

The NDC (National Drug Code) for HAWAIIAN TROPIC 2.7 g/100g is 63354-861, listed by Edgewell Personal Care Brands LLC.

Product NDC

63354-861

Package NDC

63354-861-61

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)