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 1.0%, Octocrylene 3.0%

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 prevent sunburn, not skin cancer or early skin aging.

For external use only

May stain some fabrics and surfaces

Do not use

on damaged or broken skin

When using this product

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.

Directions

apply liberally 15 minutes before sun exposure reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every two hours children under 6 months: Ask a doctor

Inactive Ingredients

Ethylhexyl Palmitate, Mineral Oil, Isopropyl Myristate, Silica, Fragrance, Cocos Nucifera (Coconut) Oil, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Aloe Barbadensis Leaf Extract.

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)
SUNSCREEN OIL SPRAY
ISLAND
TANNING
ENHANCE TAN & MOISTURIZE
COCONUT OIL
6
CRUELTY FREE | VEGAN
WATER RESISTANT (40 MINUTES)
SPF 6 UVB
8 FL. OZ (236 mL)

INGREDIENTS AND APPEARANCE

HAWAIIAN TROPIC 
avobenzone,octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-593
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
COCOA BUTTER (UNII: 512OYT1CRR)
GLYCERYL OLEATE (UNII: 4PC054V79P)
GUAVA (UNII: 74O70D6VG0)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MINERAL OIL (UNII: T5L8T28FGP)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PAPAYA (UNII: KU94FIY6JB)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
TOCOPHEROL (UNII: R0ZB2556P8)
MANGO (UNII: I629I3NR86)
COCONUT OIL (UNII: Q9L0O73W7L)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-593-16	236 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/31/2023

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

Labeler - Edgewell Personal Care Brands LLC (151179769)