HAWAIIAN TROPIC- avobenzone 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 3.0%, Octocrylene 5.0%

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.

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 temperature 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, C12-15 Alkyl Benzoate, Isopropyl Myristate, Silica,Cocos Nucifera (Coconut) Oil, Theobroma Cacao (Cocoa) Seed Butter, Amyl Acetate, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, 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, Panthenol, Water, Fragrance.

Other Information

Protect this product from excessive heat and direct sun

Questions or comments

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

Front label

HAWAIIAN

Tropic

Dry Oil

Clear Spray Sunscreen

Broad Spectrum

SPF 12

12

Water Resistant (80 minutes)

skin-nourishing formula

exotic island botanicals

Protect * Pamper * Nourish

INGREDIENTS AND APPEARANCE

HAWAIIAN TROPIC 
avobenzone octocrylene aerosol

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-875
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
COCOS NUCIFERA WHOLE (UNII: 245J88W96L)
THEOBROMA CACAO WHOLE (UNII: EB048G1S9J)
AMYL ACETATE (UNII: 92Q24NH7AS)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
MANGIFERA INDICA WHOLE (UNII: U34MFR958F)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
PSIDIUM GUAJAVA WHOLE (UNII: 4J570BB45U)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PANTHENOL (UNII: WV9CM0O67Z)
CARICA PAPAYA WHOLE (UNII: S0U63B0Q51)
COLOCASIA ESCULENTA ROOT (UNII: H7B71Q0G0D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-875-34	177 g in 1 CAN; Type 0: Not a Combination Product	01/06/2012
2	NDC: 63354-875-36	236 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)