MedPath

HAWAIIAN TROPIC

Approved
Approval ID

302982a3-e3f9-ef46-e063-6394a90abaf8

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Mar 12, 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.

Homosalate,Octocrylene,Octisalate,Avobenzone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63354-861
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Homosalate,Octocrylene,Octisalate,Avobenzone
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 12, 2025
FDA Product Classification

INGREDIENTS (19)

CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
PSIDIUM GUAJAVA FRUITInactive
Code: 74O70D6VG0
Classification: IACT
OCTISALATEActive
Quantity: 4.5 g in 100 g
Code: 4X49Y0596W
Classification: ACTIB
HOMOSALATEActive
Quantity: 9 g in 100 g
Code: V06SV4M95S
Classification: ACTIB
ETHYLHEXYL PALMITATEInactive
Code: 2865993309
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
AVOBENZONEActive
Quantity: 2.7 g in 100 g
Code: G63QQF2NOX
Classification: ACTIB
THEOBROMA CACAO (COCOA) SEED BUTTERInactive
Code: 512OYT1CRR
Classification: IACT
CARICA PAPAYA (PAPAYA) FRUITInactive
Code: KU94FIY6JB
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
SILICAInactive
Code: ETJ7Z6XBU4
Classification: IACT
MANGIFERA INDICA (MANGO) FRUITInactive
Code: I629I3NR86
Classification: IACT
OCTOCRYLENEActive
Quantity: 9 g in 100 g
Code: 5A68WGF6WM
Classification: ACTIB
DIISOPROPYL ADIPATEInactive
Code: P7E6YFV72X
Classification: IACT
PEG-8Inactive
Code: B697894SGQ
Classification: IACT
PASSIFLORA INCARNATA FRUITInactive
Code: SF206I8G4P
Classification: IACT
CERESINInactive
Code: Q1LS2UJO3A
Classification: IACT
PLUMERIA RUBRA FLOWERInactive
Code: 8P7XXY759H
Classification: IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEInactive
Code: C9H2L21V7U
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 10/1/2025

Principal Display Panel

HAWAIIAN TROPIC

SUNSCREEN STICK

WEIGHTLESS

HYDRATION

12 HOUR MOISTURIZATION

60+

BROAD SPECTRUM SPF 60+ UVA/UVB

SWEAT | WATER RESISTANT (80 MINUTES)

NET WT. 0.5 OZ (14.2 g)

Front Label

Back Label

NEW

HAWAIIAN

TROPIC

SUNSCREEN STICK

WEIGHTLESS

HYDRATION

12 HOUR MOISTURIZATION

WON'T CLOG

PORES

DERM TESTED

BLENDS ACROSS

SKIN TONES

VEGAN

60+

BROAD SPECTRUM

SPF 60+ UVA/UVB

SWEAT | WATER

RESISTANT

(80 MINUTES)

NET WT. 0.5 OZ (14.2 g)

Front Card

Back Card

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 10/1/2025

Uses

■ helps prevent sunburn ■ if used as directed with other sun protection measures (seeDirections) decreases the risk of skin cancer and early aging caused by the sun

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 10/1/2025

Active Ingredients

Avobenzone 2.7%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 9.0%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 10/1/2025

Purpose

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 10/1/2025

Warnings

For external use only.

May stain some fabrics.

Do not use

■ on damaged or broken skin.

When using this product

■ keep out of eyes. Rinse with warm 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: 10/1/2025

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 long-sleeved shirts, pants, hats, and sunglasses ■ children under 6 months: Ask a doctor

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 10/1/2025

Other Information

■ Protect the product in this container from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 10/1/2025

Inactive Ingredients:

Ozokerite, Ethylhexyl Palmitate, Caprylic/Capric Triglyceride, Diisopropyl Adipate, Cetyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Dimethicone, PEG‐8, Caprylyl Glycol, Silica, Fragrance, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 10/1/2025

Questions or comments?

Call 1-800-NO UV Ray

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HAWAIIAN TROPIC - FDA Drug Approval Details