HAWAIIAN TROPIC ISLAND SPORT SUNSCREEN BROAD SPECTRUM SPF 15- avobenzone,homosalate,octisalate,octocrylene lotion

Hawaiian Tropic Island Sport Sunscreen Broad Spectrum SPF 15 by

Drug Labeling and Warnings

Hawaiian Tropic Island Sport Sunscreen Broad Spectrum SPF 15 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%, Homosalate 3.0%, Octisalate 2.0%, Octocrylene 3.0%

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, Cetearyl Alcohol, Phenoxyethanol, Benzyl Alcohol, Glycerin, Diisopropyl Adipate, Acrylates/C12-22 Alkyl Methacrylate Copolymer Fragrance, C12-15 Alkyl Benzoate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Coco-Glucoside, Chlorphenesin, Ceteth-10 Phosphate, Dicetyl Phosphate, Dimethicone, Sodium Hydroxide, Xanthan Gum, 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*

15

UVA/UVB BROAD SPECTRUM

SPF 15

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 15 
avobenzone,homosalate,octisalate,octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-495
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
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PAPAYA (UNII: KU94FIY6JB)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
COCO GLUCOSIDE (UNII: ICS790225B)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
XANTHAN GUM (UNII: TTV12P4NEE)
GUAVA (UNII: 74O70D6VG0)
PANTHENOL (UNII: WV9CM0O67Z)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
CHLORPHENESIN (UNII: I670DAL4SZ)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MANGO (UNII: I629I3NR86)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-495-16	227 g in 1 BOTTLE; Type 0: Not a Combination Product	01/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/17/2020

Labeler - Edgewell Personal Care Brands LLC (151179769)