HAWAIIAN TROPIC- avobenzone, octocrylene, oxybenzone 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 0.5%, Octocrylene 3.5%, Oxybenzone 1.5%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Warnings

For external use only

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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.

Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

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. May stain some fabrics

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 and then apply to face. Do not apply in windy conditions Use in a well-ventilated area Reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours Children under 6 months: Ask a doctor

Inactive ingredients

Mineral Oil, Ethylhexyl Palmitate, Diisopropyl Adipate, Isopropyl Myristate, Silica, Cocos Nucifera (Coconut) Oil, Theobroma Cacao (Cocoa) Seed Butter, Amyl Acetate, Aloe Barbadensis Leaf Extract,PEG-8 Dimethicone, 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, Octyldodecanol, Retinyl Palmitate, Tocopheryl Acetate, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Fragrance.

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

TANNING

Dry Oil

Clear Spray Sunscreen

SPF 6

6

water resistant (80 minutes)

skin-nourishing formula

exotic island botanicals

Protect Pamper Nourish

INGREDIENTS AND APPEARANCE

HAWAIIAN TROPIC 
avobenzone, octocrylene, oxybenzone aerosol

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3.5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	1.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCOA BUTTER (UNII: 512OYT1CRR)
CARICA PAPAYA WHOLE (UNII: S0U63B0Q51)
MANGIFERA INDICA WHOLE (UNII: U34MFR958F)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
PSIDIUM GUAJAVA WHOLE (UNII: 4J570BB45U)
OCTYLDODECANOL (UNII: 461N1O614Y)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
MINERAL OIL (UNII: T5L8T28FGP)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
COCONUT OIL (UNII: Q9L0O73W7L)
AMYL ACETATE (UNII: 92Q24NH7AS)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
COLOCASIA ESCULENTA ROOT (UNII: H7B71Q0G0D)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM PROPOXYHYDROXYPROPYL THIOSULFATE SILICA (UNII: 208G222332)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-040-34	170 g in 1 CAN; Type 0: Not a Combination Product	01/06/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/06/2012

Labeler - Edgewell Personal Care Brands LLC (151179769)