HAWAIIAN TROPIC- avobenzone,homosalate,octisalate,octocrylene aerosol, 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 2.0%, Homosalate 6.0%, Octisalate 4.5%, 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

Flammable: Do not puncture or incinerate. Contents under pressure. Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking. Do not store at temperatures above 120°F.

May stain some fabrics and surfaces.

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.

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 then apply to face. Do not apply in windy conditions Use in 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 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-sleeve shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor.

Inactive Ingredients

Alcohol Denat., Isobutane, Isododecane, Diisopropyl Adipate, Mineral Oil, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer, Lauryl PEG-8 Dimethicone, Caprylyl Glycol, Methyl Dihydroabietate, Fragrance, Argania Spinosa Kernel Oil, Olea Europaea (Olive) Fruit Oil, Vitis Vinifera (Grape) Seed Oil, Ascorbyl Palmitate, Tocopheryl Acetate, Cocos Nucifera (Coconut) Oil, Glycine Soja (Soybean) Oil, Panthenol, Water, Psidium Guajava Fruit Extract, Plumeria Acutifolia Flower Extract, Passiflora Incarnata Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Aloe Barbadensis Leaf Extract, Daucus Carota Sativa (Carrot) Root Extract.

​Principal Display Panel

HAWAIIAN
TROPIC(R)
SUNSCREEN DRY OIL SPRAY
PROTECTIVE
TANNING
ENHANCE TAN & MOISTURIZE
COCONUT OIL
30
CRUELTY FREE | VEGAN
BROAD SPECTRUM SPF 30 UVA/UVB
WATER RESISTANT (80 MINUTES)
NET WT 6.0 OZ (170g)

INGREDIENTS AND APPEARANCE

HAWAIIAN TROPIC 
avobenzone,homosalate,octisalate,octocrylene aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-613
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	6 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	6 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
PAPAYA (UNII: KU94FIY6JB)
CARROT (UNII: L56Z1JK48B)
ISODODECANE (UNII: A8289P68Y2)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PANTHENOL (UNII: WV9CM0O67Z)
MANGO (UNII: I629I3NR86)
LAURYL PEG-8 DIMETHICONE (300 CPS) (UNII: ELL2U7K8T8)
SOYBEAN OIL (UNII: 241ATL177A)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
GRAPE SEED OIL (UNII: 930MLC8XGG)
OLIVE OIL (UNII: 6UYK2W1W1E)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
GUAVA (UNII: 74O70D6VG0)
ARGAN OIL (UNII: 4V59G5UW9X)
ISOBUTANE (UNII: BXR49TP611)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
MINERAL OIL (UNII: T5L8T28FGP)
COCONUT OIL (UNII: Q9L0O73W7L)
GLYCERYL OLEATE (UNII: 4PC054V79P)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-613-34	170 g in 1 CAN; Type 0: Not a Combination Product	10/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/31/2023

Labeler - Edgewell Personal Care Brands LLC (151179769)