HAWAIIAN TROPIC- avobenzone,homosalate,octisalate,octocrylene gel

HAWAIIAN TROPIC by

Drug Labeling and Warnings

HAWAIIAN TROPIC by is a Otc medication manufactured, distributed, or labeled by Edgewell Personal Care Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Avobenzone 2.7%, Homosalate 5.0%, Octisalate 4.5%, Octocrylene 9.0%

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 aging caused by the sun.

Warnings

For external use only.

May stain some fabrics.

Do not use

on damaged or broken skin.

When using this product

keep out of eyes. Rinse with warm 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

Inactive Ingredients:

Petrolatum, Theobroma Cacao (Cocoa) Seed Butter, Beeswax, Ozokerite, Polyglyceryl-3 Beeswax, Polydipentene, Butyrospermum Parkii (Shea) Butter, Hydrogenated Coconut Oil, Hydrogenated Soybean Oil, Flavor, Synthetic Beeswax, Euphorbia Cerifera (Candelilla) Wax, Cetyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Lecithin, Stevioside, Tocopherol, Water.

Other Information

Protect the product in this container from excessive heat and direct sun

Questions or comments?

Call 1-800-NO UV Ray

PRINCIPAL DISPLAY PANEL

NEW

HAWAIIAN TROPIC

SUNSCREEN

LIP BALM

12 HR MOISTURIZATION

ENRICHED WITH

VITAMIN E &

SHEA BUTTER

WATER

RESISTANT

(80 MINUTES)

30

BROAD SPECTRUM

SPF 30 UVA/UVB

NET WT. 0.35 OZ. (9.9 g)

HAWAIIAN TROPIC

SUNSCREEN

LIP BALM

12 HR MOISTURIZATION

ENRICHED WITH

VITAMIN E &

SHEA BUTTER

WATER RESISTANT (80 MINUTES)

30

ISLAND COCONUT

BROAD SPECTRUM SPF 30 UVA/UVB

NET WT. 0.35 OZ. (9.9 g)

INGREDIENTS AND APPEARANCE

HAWAIIAN TROPIC 
avobenzone,homosalate,octisalate,octocrylene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-701
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.7 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CANDELILLA WAX (UNII: WL0328HX19)
CETYL ALCOHOL (UNII: 936JST6JCN)
SUNFLOWER OIL (UNII: 3W1JG795YI)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
STEVIOSIDE (UNII: 0YON5MXJ9P)
PETROLATUM (UNII: 4T6H12BN9U)
COCOA BUTTER (UNII: 512OYT1CRR)
YELLOW WAX (UNII: 2ZA36H0S2V)
POLYGLYCERYL-3 BEESWAX (UNII: Z98M8HW9A6)
SHEA BUTTER (UNII: K49155WL9Y)
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-701-21	9.9 g in 1 TUBE; Type 0: Not a Combination Product	10/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/01/2024

Labeler - Edgewell Personal Care Brands LLC (151179769)