HAWAIIAN TROPIC- avobenzone,homosalate,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, Playtex Manufacturing Inc. (Ormond Beach). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 2.0%, Homosalate 7.0%, Octocrylene 5.0%

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 expose to heat or 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-sleeved shirts, pants, hats, and sunglasses children under 6 months: Ask a doctor

Inactive Ingredients

Alcohol Denat., Isobutane, Isododecane, Diisopropyl Adipate, Lauryl PEG-8 Dimethicone, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer, Caprylyl Glycol, Fragrance, Methyl Dihydroabietate, Mineral Oil, Ascorbyl Palmitate, Tocopheryl Acetate, Panthenol, Water, Aloe Barbadensis Leaf Extract, Carica Papaya (Papaya) Fruit Extract, Colocasia Antiquorum Root Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract.

Other Information

protect this product from excessive heat and direct sun

Questions or Comments?

Call 1-800-NO UV RAY, Mon-Fri

Principal Display Panel

HAWAIIAN
TROPIC(R)
SPORT SUNSCREEN SPRAY
EVERYDAY
ACTIVE(TM)
SWEAT | WATER RESISTANT
(80 MINUTES)
30
CRUELTY FREE | VEGAN
BROAD SPECTRUM SPF 30 UVA/UVB
NET WT 6 OZ (170 g)

BONUS

33% MORE

HAWAIIAN
TROPIC(R)
SPORT SUNSCREEN SPRAY
EVERYDAY
ACTIVE(TM)
SWEAT | WATER RESISTANT
(80 MINUTES)
30
CRUELTY FREE | VEGAN
BROAD SPECTRUM SPF 30 UVA/UVB
NET WT 8 OZ (226 g)

INGREDIENTS AND APPEARANCE

HAWAIIAN TROPIC 
avobenzone,homosalate,octocrylene aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-299
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LAURYL PEG-8 DIMETHICONE (300 CPS) (UNII: ELL2U7K8T8)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
PAPAYA (UNII: KU94FIY6JB)
ALCOHOL (UNII: 3K9958V90M)
COLOCASIA ESCULENTA ROOT (UNII: H7B71Q0G0D)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISODODECANE (UNII: A8289P68Y2)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
WATER (UNII: 059QF0KO0R)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
ISOBUTANE (UNII: BXR49TP611)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PANTHENOL (UNII: WV9CM0O67Z)
MINERAL OIL (UNII: T5L8T28FGP)
MANGO (UNII: I629I3NR86)
GUAVA (UNII: 74O70D6VG0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-299-34	170 g in 1 CAN; Type 0: Not a Combination Product	10/31/2023
2	NDC: 63354-299-36	226 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)

Establishment
Name	Address	ID/FEI	Business Operations
Playtex Manufacturing Inc. (Ormond Beach)		963501502	manufacture(63354-299)