HAWAIIAN TROPIC- avobenzone, homosalate, octisalate, octocrylene aerosol

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 1.5%, Homosalate 3.0%, Octisalate 1.0%, Octocrylene 3.0%

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 brokenb skin

When using this product

keep out of eyes. Keep away from face to avoid breathing it. 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.

May stain some fabrics.

Flammable

Contents under pressure.

Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120F.

Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking

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 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

Alcohol Denat., Isobutane, Isododecane, Diisopropyl Adipate, Dimethicone, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Fragrance, Hydroxypropylcellulose, Mineral Oil, Ascorbyl Palmitate, Tocopheryl Acetate, Panthenol, Water, 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, Aloe Barbadensis Leaf Extract.

Other Information

Protect this product from excessive heat and direct sun

Questions or Comments?

Call 1-800-NO-UVRAY, Mon-Fri

PDP

HAWAIIAN

Tropic®

Silk

HYDRATION

Clear Spray Sunscreen

WEIGHTLESS

Feels as if it's barely on

15

BROAD SPECTRUM

SPF 15

12 HOUR Moisturization

with UVA & UVB Protection

Fast absorbing

Water Resistant

(80 minutes)

NET WT 6 OZ. (170g)

HAWAIIAN

Tropic

Silk

HYDRATION

Clear Spray Sunscreen

WEIGHTLESS

15

BROAD SPECTRUM

SPF 15

12 HOUR Moisturization

with UVA & UVB Protection

Fast absorbing

Water Resistant

(80 minutes)

INGREDIENTS AND APPEARANCE

HAWAIIAN TROPIC 
avobenzone, homosalate, octisalate, octocrylene aerosol

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-826
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ISOBUTANE (UNII: BXR49TP611)
ISODODECANE (UNII: A8289P68Y2)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
DIMETHICONE (UNII: 92RU3N3Y1O)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
MINERAL OIL (UNII: T5L8T28FGP)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
PANTHENOL (UNII: WV9CM0O67Z)
WATER (UNII: 059QF0KO0R)
PAPAYA (UNII: KU94FIY6JB)
COLOCASIA ESCULENTA ROOT (UNII: H7B71Q0G0D)
MANGO JUICE (UNII: IU6I1JNV24)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
PSIDIUM GUAJAVA WHOLE (UNII: 4J570BB45U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-826-34	170 g in 1 CAN; Type 0: Not a Combination Product	01/02/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/02/2017

Labeler - Edgewell Personal Care Brands LLC (151179769)