HAWAIIAN TROPIC- avobenzone,homosalate,octocrylene spray

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 8.0% Octocrylene 6.0%

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 skin aging caused by the sun

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. May stain some fabrics and surfaces.

Directions

Shake well Hold container 4 to 6 inches from the skin to apply. Don’t spray directly into face. Apply on hand then apply to face. Spray evenly and liberally on your skin. Apply 15 minutes before sun exposure. Reapply throughout the day at least every 2 hours, after 80 minutes of swimming orsweating immediately after towel drying 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

Water, Diisopropyl Adipate, Butyloctyl Salicylate, Butylene Glycol, Polyglyceryl-3 Methylglucose Distearate, Oryza Sativa (Rice) Starch, Phenoxyethanol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Glycol, Chlorphenesin, PEG-100 Stearate, Glyceryl Stearate, Fragrance, Glycerin, Sodium Polyacrylate, Aloe Barbadensis Leaf Juice Powder, Disodium EDTA, Sodium Hyaluronate, Hibiscus Sabdariffa Flower Extract, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Psidium Guajava Fruit Extract, Plumeria Acutifolia Flower Extract, Passiflora Incarnata Fruit Extract.

Other Information

Protect this product from excessive heat and direct sun

Questions or Comments?

1-800-NO UV RAY, Mon-Fri

PRINCIPAL DISPLAY PANEL

HAWAIIAN TROPIC

WATER SUNSCREEN MIST

WEIGHTLESS

HYDRATION FACE

12 HR MOISTURIZATION

HYALURONIC ACID

30

ALCOHOL FREE

CRUELTY FREE / VEGAN

BROAD SPECTRUM SPF 30 UVA/UVB

2.1 FL. OZ (62 ml)

INGREDIENTS AND APPEARANCE

HAWAIIAN TROPIC 
avobenzone,homosalate,octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-712
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	6 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PEG-100 STEARATE (UNII: YD01N1999R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
CHLORPHENESIN (UNII: I670DAL4SZ)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GUAVA (UNII: 74O70D6VG0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)
MANGO (UNII: I629I3NR86)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
WATER (UNII: 059QF0KO0R)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (UNII: W19EIO0DBE)
STARCH, RICE (UNII: 4DGK8B7I3S)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PAPAYA (UNII: KU94FIY6JB)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-712-12	62 g in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/01/2023

Labeler - Edgewell Personal Care Brands LLC (151179769)