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, Formulated Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 2.0%, Homosalate 5.5%, Octisalate 4.5%, Octocrylene 4.0%

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 ot contact a Poison Control Center right away. Intentional misuse by deliberately concentrating or 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 on hands then apply to face. Do not apply in windy conditions. use in a well-ventilated area. reapply: after 80 minutes of swimming or sweatng, 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, Ethylhexyl Palmitate, Ethylhexyl Stearate, Ethylhexyl Benzoate, Quaternium-90 Sepiolite, Quaternium-90 Montmorillonite, VA/Butl Maleate/Isobornyl Acrylate Copolymer, Mica, Mineral Oil, Tocopheryl Aceteate, 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, 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

30

BROAD SPECTRUM

SPF 30

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: 63354-720
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	5.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPANEDIOL (UNII: 5965N8W85T)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISOBUTANE (UNII: BXR49TP611)
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
PANTHENOL (UNII: WV9CM0O67Z)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-720-34	170 g in 1 CAN; Type 0: Not a Combination Product	03/31/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/31/2015

Labeler - Edgewell Personal Care Brands LLC (151179769)

Establishment
Name	Address	ID/FEI	Business Operations
Formulated Solutions, LLC		143266687	manufacture(63354-720)