Hawaiian Tropic Lip Balm Sunscreen SPF 25

Manufacturer
Edgewell Personal Care Brands LLC
Effective date
2023-10-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:23:23

Label at a glance#

ProductHawaiian Tropic Lip Balm Sunscreen SPF 25
Active ingredientAVOBENZONE, OCTOCRYLENE, OCTISALATE
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.

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

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.

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.

Inactive ingredient

INACTIVE INGREDIENT SECTION

Caprylic/Capric Triglyceride, Ozokerite, Petrolatum, Ethylhexyl Palmitate, Flavor, Oryza Sativa (RIce) Bran Wax, VP/Eicosene Copolymer, PEG-8, 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

Primary Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TROPICAL flavor

SPF

25

HAWAIIAN

Tropic (R)

LIP BALM

Sunscreen Stick

Reef Friendly*

MOISTURIZES

FOR 12 HOURS

.14 OZ.

63354-902-61 Package63354-902-61 Package63354-902-61 Wrap63354-902-61 Wrap

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63354-902-612023-10-24C16284748780-1d6a99b39-4c57-a426-e053-dadaa90af4c2b6387d2a-f962-5c1b-e053-2a95a90a83eb
63354-902-612022-01-28C16284748780-1d6a99b39-4c57-a426-e053-dadaa90af4c2b6387d2a-f962-5c1b-e053-2a95a90a83eb

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-902HAWAIIAN TROPIC LIP BALM SUNSCREEN SPF 25 (AVOBENZONE,OCTISALATE,OCTOCRYLENE) STICK [EDGEWELL PERSONAL CARE BRANDS LLC]2Legacy NDC20231025_b6387d2a-f962-5c1b-e053-2a95a90a83eb.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-90263354-902-61

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
463b505b-8f37-ce48-e063-6394a90a1d84b6387d2a-f962-5c1b-e053-2a95a90a83eb2025-12-18WarningsExact identifier
spl set id: b6387d2a-f962-5c1b-e053-2a95a90a83eb

Reported adverse events (FAERS/openFDA)#

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