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 Ingredient

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.

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

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, Sodium Polyacrylate, Glycerin, Aloe Barbadensis Leaf Juice Powder, Disodium EDTA, Sodium Hyaluronate, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Psidium Guajava Fruit Extract, Plumeria Acutifolia Flower 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

12 HR MOISTURIZATION

HYALURONIC ACID

30

ALCOHOL FREE

CRUELTY FREE / VEGAN

BROAD SPECTRUM SPF 30 UVA/UVB

5. Fl. OZ (153 ml)

INGREDIENTS AND APPEARANCE

HAWAIIAN TROPIC 
avobenzone,homosalate,octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-324
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
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (UNII: W19EIO0DBE)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PAPAYA (UNII: KU94FIY6JB)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GUAVA (UNII: 74O70D6VG0)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
WATER (UNII: 059QF0KO0R)
STARCH, RICE (UNII: 4DGK8B7I3S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-100 STEARATE (UNII: YD01N1999R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MANGO (UNII: I629I3NR86)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-324-14	153 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)