HAWAIIAN TROPIC- avobenzone,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 3.0%, Octocrylene 5.0%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Warnings

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. For external use only.

Flammable: Do not puncture or incinerate container. 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 120°F.

May stain some fabrics and surfaces.

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.

Directions

Shake well 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 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, Fragrance, 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, Water, Panthenol.

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(R)
CLEAR SPRAY SUNSCREEN
ISLAND
TANNING
ENHANCE TAN & MOISTURIZE
COCONUT OIL
12
CRUELTY FREE | VEGAN
BROAD SPECTRUM SPF 12 UVA/UVB
WATER RESISTANT (80 MINUTES)
NET WT 5.5 OZ (158g)

INGREDIENTS AND APPEARANCE

HAWAIIAN TROPIC 
avobenzone,octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-805
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MINERAL OIL (UNII: T5L8T28FGP)
MANGO (UNII: I629I3NR86)
COCONUT OIL (UNII: Q9L0O73W7L)
COCOA BUTTER (UNII: 512OYT1CRR)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PAPAYA (UNII: KU94FIY6JB)
COLOCASIA ESCULENTA ROOT (UNII: H7B71Q0G0D)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
GUAVA (UNII: 74O70D6VG0)
WATER (UNII: 059QF0KO0R)
PANTHENOL (UNII: WV9CM0O67Z)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
AMYL ACETATE (UNII: 92Q24NH7AS)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-805-14	158 g in 1 CAN; Type 0: Not a Combination Product	10/31/2023	10/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/31/2023	10/01/2025

Labeler - Edgewell Personal Care Brands LLC (151179769)