MedPath

HAWAIIAN TROPIC

Approved
Approval ID

08f34b31-6337-ef7c-e063-6294a90a1c4c

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 28, 2025

Manufacturers
FDA

Edgewell Personal Care Brands LLC

DUNS: 151179769

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

AVOBENZONE,OCTOCRYLENE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63354-593
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
AVOBENZONE,OCTOCRYLENE
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 28, 2025
FDA Product Classification

INGREDIENTS (16)

COCOA BUTTERInactive
Code: 512OYT1CRR
Classification: IACT
OCTOCRYLENEActive
Quantity: 3 g in 100 g
Code: 5A68WGF6WM
Classification: ACTIB
GLYCERYL OLEATEInactive
Code: 4PC054V79P
Classification: IACT
GUAVAInactive
Code: 74O70D6VG0
Classification: IACT
PASSIFLORA INCARNATA FRUITInactive
Code: SF206I8G4P
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
ETHYLHEXYL PALMITATEInactive
Code: 2865993309
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
AVOBENZONEActive
Quantity: 1 g in 100 g
Code: G63QQF2NOX
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
COCONUT OILInactive
Code: Q9L0O73W7L
Classification: IACT
PAPAYAInactive
Code: KU94FIY6JB
Classification: IACT
MANGOInactive
Code: I629I3NR86
Classification: IACT
PLUMERIA RUBRA FLOWERInactive
Code: 8P7XXY759H
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 10/30/2023

Principal Display Panel

HAWAIIAN
TROPIC(R)
SUNSCREEN OIL SPRAY
ISLAND
TANNING
ENHANCE TAN & MOISTURIZE
COCONUT OIL
6
DERM TESTED | VEGAN
WATER RESISTANT (40 MINUTES)
SPF 6 UVB
8 FL. OZ (236 mL)

Front Label

Back Label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 10/30/2023

Uses

• helps prevent sunburn

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 10/30/2023

Active Ingredients

Avobenzone 1.0%, Octocrylene 3.0%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 10/30/2023

Purpose

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 10/30/2023

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

• 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 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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 10/30/2023

Directions

• apply liberally 15 minutes before sun exposure • reapply: • after 40 minutes of swimming or sweating • immediately after towel drying • at least every two hours • children under 6 months: Ask a doctor

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 10/30/2023

Other Information

• protect this product from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 10/30/2023

Inactive Ingredients

Ethylhexyl Palmitate, Mineral Oil, Isopropyl Myristate, Silica, Fragrance, Cocos Nucifera (Coconut) Oil, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Aloe Barbadensis Leaf Extract.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 10/30/2023

Questions or Comments?

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

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HAWAIIAN TROPIC - FDA Drug Approval Details