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 Ingredients

Avobenzone 2.0%, Octocrylene 2.0%, Oxybenzone 2.0%

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. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value 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.

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 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, Ethylhexyl Benzoate, Cetearyl Alcohol, Glycerin, VP/Eicosene Copolymer, Diisopropyl Adipate, Isopropyl Myristate, Isopropyl Palmitate, Phenethyl Benzoate, Polymethylsilsesquioxane, Phenoxyethanol, Polyethylene, Caprylyl Glycol, Dimethicone, Fragrance, Coco-Glucoside, Sodium Polyacrylate, Ceteth-10 Phosphate, Dicetyl Phosphate, Methylparaben, Xanthan Gum, Propylparaben, Carbomer, Disodium EDTA, Paraffin, Sodium Hydroxide, Mica, Butyrospermum Parkii (Shea) Butter, Mangifera Indica (Mango) Seed Butter, Silk Amino Acids, 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, Bismuth Oxychloride, Iron Oxides.

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

Silk

HYDRATION

Lotion Sunscreen

12 Hour Moisturization

with hydrating ribbons

12

BROAD SPECTRUM

SPF 12

UVA/UVB protection

INGREDIENTS AND APPEARANCE

HAWAIIAN TROPIC 
avobenzone octocrylene oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-590
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
AMINO ACIDS, SILK (UNII: V0L00EX1IA)
SHEA BUTTER (UNII: K49155WL9Y)
PANTHENOL (UNII: WV9CM0O67Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARICA PAPAYA WHOLE (UNII: S0U63B0Q51)
COLOCASIA ESCULENTA ROOT (UNII: H7B71Q0G0D)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
PSIDIUM GUAJAVA WHOLE (UNII: 4J570BB45U)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
GLYCERIN (UNII: PDC6A3C0OX)
2-ETHYLHEXYL BENZOATE (UNII: R63ZWW1A13)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
CARBOMER 940 (UNII: 4Q93RCW27E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
MANGIFERA INDICA WHOLE (UNII: U34MFR958F)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
COCO GLUCOSIDE (UNII: ICS790225B)
MICA (UNII: V8A1AW0880)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
PHENETHYL BENZOATE (UNII: 0C143929GK)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PARAFFIN (UNII: I9O0E3H2ZE)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-590-54	180 g in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2015

Labeler - Edgewell Personal Care Brands LLC (151179769)