HAWAIIAN TROPIC ISLAND SPORT SPF 30- avobenzone and octocrylene and oxybenzone spray

Hawaiian Tropic Island Sport SPF 30 by

Drug Labeling and Warnings

Hawaiian Tropic Island Sport SPF 30 by is a Otc medication manufactured, distributed, or labeled by Accra-Pac, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Avobenzone 0.01mL / 1mL

Octocrylene 0.077mL / 1mL

Oxybenzone 0.03mL / 1mL

Purpose

Sunscreen

Use

helps prevent sunburn

Warnings

For external use only

Do not spray directly into face

Flammable: do not use near heat, flame, or while smoking

When using this product

avoid spraying in eyes. If contact occurs, rinse thoroughly with water.

do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

Stop use and ask a doctor if

irritation or rash develops

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply generously and evenly to all areas 15 minutes before sun exposure

spray on hands to apply to face

use in well-ventilated area

reapply at frequent intervals and after swimming or towel drying

ask a doctor before use on children under six months of age

Other Information

Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.

May stain some fabrics.

Inactive Ingredients

SD Alcohol 40-B, Acrylates/Octylacrylamide Copolymer, Caprylyl Glycol, Retinyl Palmitate (Vitamin A), Ascorbic Acid (Vitamin C), Tocopheryl Acetate (Vitamin E), PEG-8 Dimethicone, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Octyldodecanol, Silica, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Plumeria Acutifolia Flower Extract, Colocasia Antiquorum Root Extract, Psidium Guajava Fruit Extract, Passiflora Incarnata Fruit Extract, Mineral Oil, Aloe Barbadensis Leaf Extract, Fragrance.

Questions or Comments?

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

Distributed by:
TANNING RESEARCH
LABORATORIES,LLC
Ormond Beach, FL 32174
Made in U.S.A.

PRINCIPAL DISPLAY PANEL

NEW
HAWAIIAN
Tropic®
ISLAND
sportTM
Clear Spray Sunscreen
hydrates skin
very water resistant
skin-nourishing antioxidants
30
UVB/SPF
WITH UVA
SUNSURE
ProtectionTM
Protect Pamper Nourish
6 FL. OZ. (177 ml)

INGREDIENTS AND APPEARANCE

HAWAIIAN TROPIC ISLAND SPORT SPF 30 
avobenzone and octocrylene and oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17630-2035
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.01 mL  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.077 mL  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.03 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
OCTYLDODECANOL (UNII: 461N1O614Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PAPAYA (UNII: KU94FIY6JB)
MANGO (UNII: I629I3NR86)
PLUMERIA EXTRACT (UNII: LGC8P2PC4H)
GUAVA (UNII: 74O70D6VG0)
PASSIFLORA INCARNATA TOP (UNII: CLF5YFS11O)
MINERAL OIL (UNII: T5L8T28FGP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17630-2035-1	177 mL in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	10/03/2009

Labeler - Accra-Pac, Inc. (024213616)

Establishment
Name	Address	ID/FEI	Business Operations
Accra-Pac, Inc.		024213616	MANUFACTURE