HAWAIIAN TROPIC ISLAND SPORT SUNSCREEN BROAD SPECTRUM SPF 50- avobenzone,homosalate,octisalate,octocrylene lotion

Hawaiian Tropic Island Sport Sunscreen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Hawaiian Tropic Island Sport Sunscreen Broad Spectrum SPF 50 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 2.7%, Homosalate 9.0%, Octisalate 4.0%, Octocrylene 5.0%

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.

May stain some fabrics.

Do not use

on damaged or broken skin

When using this product

do not get into eyes. If contact occurs, rinse thoroughly with water

Stop use and ask a doctor

if irritation or rash develops.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

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, Diisopropyl Adipate, Cetearyl Alcohol, Glycerin, Phenoxyethanol, Benzyl Alcohol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Fragrance, C12-15 Alkyl Benzoate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ceteth-10 Phosphate, Dicetyl Phosphate, Coco-Glucoside, Chlorphenesin, Xanthan Gum, Dimethicone, Sodium Hydroxide, Disodium EDTA, Mangifera Indica (Mango) Seed Butter, Tocopheryl Acetate, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Panthenol, Aloe Barbadensis Leaf Juice, Sodium Ascorbyl Phosphate

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®

Sunscreen Lotion

HIGH ENDURANCE

vs. Sweat & Water

Reef Friendly*

50

UVA/UVB BROAD SPECTRUM

SPF 50

won't clog pores

non-greasy

water/sweat resistant

(80 minutes)

8 FL. OZ. (236 mL)

INGREDIENTS AND APPEARANCE

HAWAIIAN TROPIC ISLAND SPORT SUNSCREEN BROAD SPECTRUM SPF 50 
avobenzone,homosalate,octisalate,octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-497
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.7 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
WATER (UNII: 059QF0KO0R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MANGO (UNII: I629I3NR86)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
COCO GLUCOSIDE (UNII: ICS790225B)
XANTHAN GUM (UNII: TTV12P4NEE)
DECAMETHYLTETRASILOXANE (UNII: C23WAL597T)
PAPAYA (UNII: KU94FIY6JB)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
GUAVA (UNII: 74O70D6VG0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-497-16	227 g in 1 BOTTLE; Type 0: Not a Combination Product	03/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/06/2020

Labeler - Edgewell Personal Care Brands LLC (151179769)