HAWAIIAN TROPIC — v2

HAWAIIAN TROPIC

7 Views

Version

v2

Effective date

September 28, 2025

Original packager

Yes

Sections captured

14

Identifiers

Document ID
3fe83767-3861-b205-e063-6394a90a38eb
Set ID
203c82a2-0131-8023-e063-6294a90aba7b
Application numbers
M020
Product NDCs
63354-611
Package NDCs
63354-611-22
Original packager NDCs
—

Names & Manufacturers

Brand names
HAWAIIAN TROPIC
Generic names
AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE
Manufacturer names
Edgewell Personal Care Brands LLC
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Routes
TOPICAL
Pharmacologic class (PE)
—
Pharmacologic class (EPC)
—
Pharmacologic class (CS)
—
Mechanism of action
—

Other identifiers

NUI
—
RxCUI
—
UNII
4X49Y0596W, 5A68WGF6WM, G63QQF2NOX, V06SV4M95S
UPC
—

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active Ingredients Avobenzone 3.0%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 6.5%
Do Not Use (1)

Sequence 1

Do not use on damaged or broken skin
Dosage And Administration (1)

Sequence 1

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 Ingredient (1)

Sequence 1

Inactive Ingredients Water, Silica, Propylene Glycol, Cetyl Dimethicone, Phenoxyethanol, Mica, Sodium Polyacrylate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Glycol, Fragrance, Chlorphenesin, Glycerin, Disodium EDTA, Aloe Barbadensis Leaf Juice, Sodium Hyaluronate, Hibiscus Sabdariffa Flower Extract, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Titanium Dioxide.
Indications And Usage (1)

Sequence 1

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
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Package Label Principal Display Panel (1)

Sequence 1

Principle Display Panel HAWAIIAN TROPIC SUNSCREEN LOTION SHEER TOUCH FACE LEAVES SKIN RADIANT HYALURONIC ACID 60+ DERM TESTED | VEGAN BROAD SPECTRUM SPF 60+ 2.5 FL. OZ (74 mL) Label
Purpose (1)

Sequence 1

Purpose Sunscreen Agent
Questions (1)

Sequence 1

Questions or Comments? Call 1-800-NO UV RAY, Mon-Fri
Spl Product Data Elements (1)

Sequence 1

HAWAIIAN TROPIC AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE SODIUM POLYACRYLATE (2500000 MW) CHLORPHENESIN OCTOCRYLENE OCTOCRYLENE HOMOSALATE HOMOSALATE MICA GLYCERIN ALOE VERA LEAF HIBISCUS SABDARIFFA FLOWER MANGO PASSIFLORA INCARNATA FRUIT GUAVA EDETATE DISODIUM PAPAYA PROPYLENE GLYCOL AVOBENZONE AVOBENZONE OCTISALATE OCTISALATE HYALURONATE SODIUM WATER TITANIUM DIOXIDE PLUMERIA RUBRA FLOWER PHENOXYETHANOL SILICON DIOXIDE CAPRYLYL GLYCOL
Spl Unclassified Section (1)

Sequence 1

Other Information • protect this product from excessive heat and direct sun
Stop Use (1)

Sequence 1

Stop and ask a doctor if rash occurs.
Warnings (1)

Sequence 1

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.
When Using (1)

Sequence 1

When using this product keep out of eyes. Rinse with water to remove.

OpenFDA raw payload

{'application_number': ['M020'],
 'brand_name': ['HAWAIIAN TROPIC'],
 'generic_name': ['AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE'],
 'is_original_packager': [True],
 'manufacturer_name': ['Edgewell Personal Care Brands LLC'],
 'package_ndc': ['63354-611-22'],
 'product_ndc': ['63354-611'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'spl_id': ['3fe83767-3861-b205-e063-6394a90a38eb'],
 'spl_set_id': ['203c82a2-0131-8023-e063-6294a90aba7b'],
 'substance_name': ['AVOBENZONE', 'HOMOSALATE', 'OCTISALATE', 'OCTOCRYLENE'],
 'unii': ['G63QQF2NOX', 'V06SV4M95S', '4X49Y0596W', '5A68WGF6WM']}