HAWAIIAN TROPIC- avobenzone, octocrylene lotion

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 1%

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 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. May stain some fabrics

Directions

Apply liberally 15 minutes before sun exposure 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

Water, Petrolatum, Diisopropyl Adipate, Propylene Glycol, Polyglyceryl-3 Methylglucose Distearate, Glyceryl Stearate, Cetyl Alcohol, PEG-100 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Theobroma Cacao (Cocoa) Seed Butter, Butyrospermum Parkii (Shea) Butter, Disodium EDTA, Panthenol, 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, Aloe Barbadensis Leaf Juice, Phenoxyethanol, Methylparaben, Propylparaben, 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®

ISLAND TANNING

Lotion Sunscreen

COCOA BUTTER

Nourishes Skin

Enhances Your Tan

8

BROAD SPECTRUM

SPF 8

Fast Absorbing

Water Resistant (80 Minutes)

8 FL. OZ. (236 mL)

HAWAIIAN

Tropic

SHEER TOUCH

Lotion Sunscreen

Broad Spectrum

SPF 8

8

UVA & UVB protection

water resistant (80 minutes)

Skin-nourishing formula

Protect Pamper Nourish

INGREDIENTS AND APPEARANCE

HAWAIIAN TROPIC 
avobenzone, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-625
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PEG-100 STEARATE (UNII: YD01N1999R)
COLOCASIA ESCULENTA ROOT (UNII: H7B71Q0G0D)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
PSIDIUM GUAJAVA WHOLE (UNII: 4J570BB45U)
METHYLPARABEN (UNII: A2I8C7HI9T)
SHEA BUTTER (UNII: K49155WL9Y)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PAPAYA (UNII: KU94FIY6JB)
MANGIFERA INDICA WHOLE (UNII: U34MFR958F)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETYL ALCOHOL (UNII: 936JST6JCN)
TROLAMINE (UNII: 9O3K93S3TK)
COCOA BUTTER (UNII: 512OYT1CRR)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PANTHENOL (UNII: WV9CM0O67Z)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-625-56	236 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2012

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

Labeler - Edgewell Personal Care Brands LLC (151179769)