HAWAIIAN TROPIC- avobenzone,octisalate,octocrylene 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 2.7%, Octisalate 4.5%, Octocrylene 5.2%

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 and surfaces.

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 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 longsleeved shirts, pants, hats, and sunglasses children under 6 months: Ask a doctor.

Inactive Ingredients

Water, Carthamus Tinctorius (Safflower) Seed Oil, Diisopropyl Adipate, Oryza Sativa (Rice) Starch, Glycerin, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Alcohol Denat., Phenoxyethanol, Carbomer, Caprylyl Glycol, Sodium Hydroxide, Chlorphenesin, Fragrance, Gluconolactone, Xanthan Gum, Disodium EDTA, Tocopheryl Acetate, Panthenol, Aloe Barbadensis Leaf Juice, Zea Mays (Corn) Oil, Sodium Ascorbyl Phosphate, Beta-Carotene, Carica Papaya (Papaya) Fruit 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?

1-800-NO UV RAY, Mon-Fri

Principal Display Panel

NEW!

MORE HYDRATING

HAWAIIAN TROPIC

NON-GREASY SUNSCREEN

WEIGHTLESS

HYDRATION

12HR MOISTURIZATION*

ISLAND BOTANICALS

50

CRUELTY FREE / VEGAN

BROAD SPECTRUM SPF 50 UVA/UVB

WATER RESISTANT (80 MINUTES)

6 FL. OZ. (177 mL)

INGREDIENTS AND APPEARANCE

HAWAIIAN TROPIC 
avobenzone,octisalate,octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-512
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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
CHLORPHENESIN (UNII: I670DAL4SZ)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
WATER (UNII: 059QF0KO0R)
STARCH, RICE (UNII: 4DGK8B7I3S)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
DEHYDRATED ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GUAVA (UNII: 74O70D6VG0)
PAPAYA (UNII: KU94FIY6JB)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
CORN OIL (UNII: 8470G57WFM)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BETA CAROTENE (UNII: 01YAE03M7J)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SAFFLOWER OIL (UNII: 65UEH262IS)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PANTHENOL (UNII: WV9CM0O67Z)
MANGO (UNII: I629I3NR86)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-512-54	177 g in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/01/2023

Labeler - Edgewell Personal Care Brands LLC (151179769)