HAWAIIAN TROPIC- avobenzone, octocrylene, oxybenzone 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 Ingredient

Avobenzone 3%, Octocrylene 6%, Oxybenzone 4%.

Purpose

Sunscreen

Uses

Helps prevent sunburn

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

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 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 Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To
decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses children under 6 months: Ask a doctor.

Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Cetearyl Alcohol, Diisopropyl Adipate, Phenethyl Benzoate, Phenoxyethanol, Polymethylsilsesquioxane, VP/Eicosene Copolymer, Caprylyl Glycol, Dimethicone, Glycerin, Fragrance, Triethanolamine, Coco-Glucoside, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Methylparaben, Ceteth-10 Phosphate, Dicetyl Phosphate, Propylparaben,
Disodium EDTA, Paraffin, Xanthan Gum, Butyrospermum Parkii (Shea) Butter, Mangifera Indica (Mango) Seed Butter, Sodium
Ascorbyl Phosphate, Tocopheryl Acetate, Panthenol, Aloe Barbadensis Leaf Juice, 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.

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

Sport

ULTRA LIGHT

high performance sunscreen

light tropical scent

50

BROAD SPECTRUM

SPF 50

UVA & UVB protection

non-greasy

won't clog pores

water/sweat resistant

(80 minutes)

INGREDIENTS AND APPEARANCE

HAWAIIAN TROPIC 
avobenzone, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-165
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	6 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
METHYLPARABEN (UNII: A2I8C7HI9T)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE SODIUM (UNII: MP1J8420LU)
MANGO (UNII: I629I3NR86)
SHEA BUTTER (UNII: K49155WL9Y)
COLOCASIA ESCULENTA ROOT (UNII: H7B71Q0G0D)
CARICA PAPAYA WHOLE (UNII: S0U63B0Q51)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PARAFFIN (UNII: I9O0E3H2ZE)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PANTHENOL (UNII: WV9CM0O67Z)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PHENETHYL BENZOATE (UNII: 0C143929GK)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
GLYCERIN (UNII: PDC6A3C0OX)
COCO GLUCOSIDE (UNII: ICS790225B)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
PSIDIUM GUAJAVA WHOLE (UNII: 4J570BB45U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-165-56	236 g in 1 BOTTLE; Type 0: Not a Combination Product	10/15/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/15/2018

Labeler - EDGEWELL PERSONAL CARE BRANDS LLC (151179769)