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 3.0%, Octocrylene 6.0%, Oxybenzone 4.0%

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 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

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 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.

Inactive Ingredients

Water, Ethylhexyl 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

PDP

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: 63354-654
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENETHYL BENZOATE (UNII: 0C143929GK)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PARAFFIN (UNII: I9O0E3H2ZE)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PSIDIUM GUAJAVA WHOLE (UNII: 4J570BB45U)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
COCO GLUCOSIDE (UNII: ICS790225B)
METHYLPARABEN (UNII: A2I8C7HI9T)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
XANTHAN GUM (UNII: TTV12P4NEE)
SHEA BUTTER (UNII: K49155WL9Y)
MANGO (UNII: I629I3NR86)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
PANTHENOL (UNII: WV9CM0O67Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARICA PAPAYA WHOLE (UNII: S0U63B0Q51)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
COLOCASIA ESCULENTA ROOT (UNII: H7B71Q0G0D)
2-ETHYLHEXYL BENZOATE (UNII: R63ZWW1A13)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-654-56	236 g in 1 BOTTLE; Type 0: Not a Combination Product	01/02/2017
2	NDC: 63354-654-57	319 g in 1 BOTTLE; Type 0: Not a Combination Product	01/02/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/02/2017

Labeler - Edgewell Personal Care Brands LLC (151179769)