HAWAIIAN TROPIC- avobenzone homosalate octisalate 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 9.0%, 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 expose to heat or store at temperatures above 120F.

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.

May stain some fabrics.

Shake Well.

Directions

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 onhands then apply to face. Do not apply in windy consitions. use un 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 risjk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in ths un, 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, Isohexadecane, Ethylhexyl Palmitate, Quaternium-90 Sepiolite, Ethylhexyl Benzoate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Quaternium-90 Montmorillonite, Mica, Mineral Oil, Tocopheryl Acetate, Panthenol, Water, Aloe Barbadensis Leaf Extract, Mangifera Indica (Mango) Seed Butter, 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, Butyrospermum Parkii (Shea) Butter, Jojoba Alcohol, Potassium Jojobate, Simmondsia Chinesis (Jojoba) Butter, Propanediol, Fragrance, Titanium Dioxide.

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

Sheer Touch

Clear Spray Sunscreen

ULTRA RADIANCE

PROTECTS, SOFTENS,

LEAVES SKIN RADIANT

50

BROAD SPECTRUM

SPF 50

UVA & UVB protection

non-greasy

water resistant

(80 minutes)

INGREDIENTS AND APPEARANCE

HAWAIIAN TROPIC 
avobenzone homosalate octisalate octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-731
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.7 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
ALCOHOL (UNII: 3K9958V90M)
ISOBUTANE (UNII: BXR49TP611)
ISOHEXADECANE (UNII: 918X1OUF1E)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
MICA (UNII: V8A1AW0880)
PANTHENOL (UNII: WV9CM0O67Z)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPANEDIOL (UNII: 5965N8W85T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-731-34	170 g in 1 CAN; Type 0: Not a Combination Product	03/30/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/30/2015

Labeler - Edgewell Personal Care Brands LLC (151179769)