Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Labeler / manufacturerEdgewell Personal Care Brands LLC
RouteTOPICAL
Drug classDrug class not supplied in source label
Product NDC63354-791
Label effective date2026-08-21
Official product label reference
Hawaiian Tropic — Edgewell Personal Care Brands LLC
This page contains 12 source sections for AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE, topical route. Label set 5991466a-e729-16b7-e063-6394a90a11ff, version 1.
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Uses described in the label
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
Purpose
Purpose Sunscreen
Dosage and administration — label text
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.
Warnings
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.
Active ingredient
Active Ingredient Avobenzone 3.0%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 9.0%
Do not use
Do not use ■ on damaged or broken skin.
While using this medicine
When using this product ■ keep out of eyes. Rinse with water to remove.
When to stop use and seek help
Stop use and ask a doctor if ■ rash occurs.
Child safety
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Unclassified section
Other Information ■ protect this product in this container from excessive heat and direct sun ■ May stain some fabrics and surfaces
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.