FDA.reportPublic FDA data

Hawaiian Tropic Lip Balm Sunscreen SPF 30

Manufacturer
Edgewell Personal Care Brands LLC
Effective date
2026-01-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:31:34

Label at a glance#

ProductHawaiian Tropic Lip Balm Sunscreen SPF 30
Active ingredientOCTOCRYLENE, OCTISALATE, AVOBENZONE
Label structure9 sections

Indications and uses

• helps prevent sunburn.

Dosage and administration

• apply liberally 15 minutes before sun exposure • reapply: after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • reapply after eating or drinking • Children under 6 months: Ask a doctor. •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 SP...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%, Octisalate 5.0%, Octocrylene 10.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

• helps prevent sunburn.

Warnings

WARNINGS SECTION

• For external use only.

May stain some fabrics.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• apply liberally 15 minutes before sun exposure • reapply: after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • reapply after eating or drinking • Children under 6 months: Ask a doctor. •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

INACTIVE INGREDIENT SECTION

Caprylic/Capric Triglyceride, Ozokerite, Petrolatum, Ethylhexyl Palmitate, VP/Eicosene Copolymer, Butyloctyl Salicylate, Flavor, PEG-8, Oryza Sativa (Rice) Bran Wax, Sodium Saccharin, Tocopheryl Acetate.

Other Information

SPL UNCLASSIFIED SECTION

• protect this product from excessive heat and direct sun.

Questions / Comments

OTC - QUESTIONS SECTION

1-800-NO UV RAY

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TROPICAL FLAVOR

HAWAIIAN TROPIC(R)
SUNSCREEN STICK

LIP BALM

12 HR MOISTURIZATION
WATER RESISTANT (80 minutes)

30

DERM TESTED | VEGAN
BROAD SPECTRUM SPF30 UVA/UVB


0.14 OZ (4.25g)

Card LabelCard Label

63354-520-61 Label63354-520-61 Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix9303020663354-520-61 Label.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-520-61Hawaiian Tropic Lip Balm Sunscreen SPF 304.25 g in 1 CYLINDERSTICK4.254

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-52063354-520-61

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
PETROLATUM4T6H12BN9UIACT
CERESINQ1LS2UJO3AIACT
ETHYLHEXYL PALMITATE2865993309IACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
SACCHARIN SODIUM ANHYDROUSI4807BK602IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
RICE BRANR60QEP13ICIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hawaiian Tropic Lip Balm Sunscreen SPF 30AVOBENZONE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCc7b71be3-f906-bd09-e053-2995a90adc612026-01-06WarningsExact identifier
ndc (package): 63354-520-61
ndc (product): 63354-520
ndc11 (package): 63354052061
spl id: 47ba86ad-2409-e733-e063-6394a90a24e3
spl set id: c7b71be3-f906-bd09-e053-2995a90adc61

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.