HAWAIIAN TROPIC

HAWAIIAN TROPIC is an FDA-registered drug product whose active ingredient is AVOBENZONE, HOMOSALATE, OCTOCRYLENE. It is labelled by Edgewell Personal Care Brands LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 63354-072, application M020, label effective 20260821. It is one of 7 FDA drug label records sharing the active ingredient AVOBENZONE, HOMOSALATE, OCTOCRYLENE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing AVOBENZONE, HOMOSALATE, OCTOCRYLENE are most often described in connection with: helps prevent, sun protection, measures see, directions decreases, risk skin, aging caused. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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.

Directions • Hold container 4 to 6 inches from hair/scalp to apply • spray liberally and evenly onto hair/scalp 15 minutes before sun exposure • do not spray directly into 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 • children under 6 months: Ask a doctor • 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.

Warnings For external use only Flammable : Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking. 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. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

FDA lists 7 drug label records with AVOBENZONE, HOMOSALATE, OCTOCRYLENE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

1 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is HAWAIIAN TROPIC used for?
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.

Who makes HAWAIIAN TROPIC?
Edgewell Personal Care Brands LLC is the labeler of record for HAWAIIAN TROPIC. 7 FDA label records share the active ingredient AVOBENZONE, HOMOSALATE, OCTOCRYLENE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does HAWAIIAN TROPIC come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is HAWAIIAN TROPIC prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing AVOBENZONE, HOMOSALATE, OCTOCRYLENE?
Yes. 7 FDA drug label records list AVOBENZONE, HOMOSALATE, OCTOCRYLENE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has HAWAIIAN TROPIC been recalled?
1 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.