Hawaiian Tropic Island Sport Sunscreen Broad Spectrum SPF 16 by Edgewell Personal Care Brands LLC

Hawaiian Tropic Island Sport Sunscreen Broad Spectrum SPF 16 by

Drug Labeling and Warnings

Hawaiian Tropic Island Sport Sunscreen Broad Spectrum SPF 16 by is a Otc medication manufactured, distributed, or labeled by Edgewell Personal Care Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAWAIIAN TROPIC ISLAND SPORT SUNSCREEN BROAD SPECTRUM SPF 16- avobenzone,homosalate,octisalate,octocrylene lotion 
Edgewell Personal Care Brands LLC

----------

Active Ingredients

Avobenzone 1.5%, Homosalate 3.0%, Octisalate 4.5%, 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, VP/Eicosene Copolymer, Mica, Diisopropyl Adipate, C12-15 Alkyl Benzoate, Glycerin, Fragrance, Neopentyl Glycol Diheptanoate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Methylparaben, Coco-Glucoside, Dimethicone, Polymethylsilsesquioxane, Propylparaben, Sodium Hydroxide, Ceteth-10 Phosphate, Dicetyl Phosphate, Propylene Glycol Dibenzoate, Disodium EDTA, Paraffin, Xanthan Gum, Butyrospermum Parkii (Shea) Butter, Jojoba Alcohol, Potassium Jojobate, Simmondsia Chinensis (Jojoba) Butter, Mangifera Indica (Mango) Seed Butter, Propanediol, Tocopheryl Acetate, 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, Panthenol, Aloe Barbadensis Leaf Juice, Sodium Ascorbyl Phosphate, Titanium Dioxide.

Other information

protect this product from excessive heat and direct sun

Questions or Comments?

Call 1-800-NO UV RAY, Mon-Fri

Primary Display Panel

HAWAIIAN

Tropic(R)

ISLAND

sport(R)

ULTRA LIGHT

high performance sunscreen

light tropical scent

15

BROAD SPECTRUM

SPF 15

UVA & UVB protection

non-greasy

won't clog pores

water/sweat resistant

(80 minutes)

8 FL. OZ. (236 mL)

HAWAIIAN TROPIC ISLAND SPORT SUNSCREEN BROAD SPECTRUM SPF 16 
avobenzone,homosalate,octisalate,octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-515
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
JOJOBA BUTTER (UNII: XIA46H803R)
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
COCO GLUCOSIDE (UNII: ICS790225B)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
SHEA BUTTER (UNII: K49155WL9Y)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
COLOCASIA ESCULENTA ROOT (UNII: H7B71Q0G0D)
GUAVA (UNII: 74O70D6VG0)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
METHYLPARABEN (UNII: A2I8C7HI9T)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
MICA (UNII: V8A1AW0880)
PAPAYA (UNII: KU94FIY6JB)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
PROPYLENE GLYCOL DIBENZOATE (UNII: EQY32Z1AN4)
PARAFFIN (UNII: I9O0E3H2ZE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) (UNII: CH428W5O62)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
MANGO (UNII: I629I3NR86)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-515-16	227 g in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2020	06/30/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/19/2020	06/30/2023

Labeler - Edgewell Personal Care Brands LLC (151179769)

Revised: 11/2023

Document Id: 0b3c8d55-7b6c-10e1-e063-6394a90a7186

34390-5

Set id: a873ed6b-02e9-38a4-e053-2a95a90aa017

Version: 2

Effective Time: 20231128