HAWAIIAN TROPIC- avobenzone,homosalate,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 2.0%, 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 and surfaces

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop 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.

Directions

apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every two 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 long-sleeved shirts, pants, hats, and sunglasses children under 6 months: Ask a doctor

Inactive Ingredients

Water, Cetearyl Alcohol, Phenoxyethanol, Mica, Benzyl Alcohol, Diisopropyl Adipate, Glycerin, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Fragrance, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Coco-Glucoside, Chlorphenesin, Ceteth-10 Phosphate, Dicetyl Phosphate, Sodium Hydroxide, Xanthan Gum, Butyrospermum Parkii (Shea) Butter, Disodium EDTA, Tocopheryl Acetate, Mangifera Indica (Mango) Seed Butter, Plumeria Acutifolia Flower Extract, Passiflora Incarnata Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit 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

PRINCIPAL DISPLAY PANEL

HAWAIIAN
TROPIC(R)
SUNSCREEN LOTION
SHEER TOUCH
LEAVES SKIN RADIANT
ISLAND BOTANICALS
15
CRUELTY FREE | VEGAN
BROAD SPECTRUM SPF 15 UVA/UVB
WATER RESISTANT (80 MINUTES)
8 FL. OZ (236 mL)

INGREDIENTS AND APPEARANCE

HAWAIIAN TROPIC 
avobenzone,homosalate,octisalate,octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-494
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
XANTHAN GUM (UNII: TTV12P4NEE)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
PAPAYA (UNII: KU94FIY6JB)
MANGO (UNII: I629I3NR86)
GUAVA (UNII: 74O70D6VG0)
PANTHENOL (UNII: WV9CM0O67Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCO GLUCOSIDE (UNII: ICS790225B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CHLORPHENESIN (UNII: I670DAL4SZ)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SHEA BUTTER (UNII: K49155WL9Y)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
MICA (UNII: V8A1AW0880)
GLYCERIN (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-494-16	236 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)