FDA.reportPublic FDA data

Sun Shades Lip Balm

Manufacturer
Melaleuca Inc.
Effective date
2025-03-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:58:49

Label at a glance#

ProductSun Shades Lip Balm Cranberry Tangerine
Active ingredientAVOBENZONE, OCTINOXATE, OXYBENZONE
Label structure13 sections

Indications and 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

Dosage and administration

■ apply liberally 15 minutes before sun exposure ■ reapply at least every 2 hours ■ use a water-resistant sunscreen if swimming or sweating ■ children under 6 months of age: 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 protectio...

Storage and handling

■ protect this product from excessive heat and direct sun ■ do not store at temperatures below 32°F (0°C) or above 120°F (49°C)

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

■ 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

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a dcotor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

■ apply liberally 15 minutes before sun exposure

■ reapply at least every 2 hours ■ use a water-resistant sunscreen if swimming or sweating ■ children under 6 months of age: 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-sleeve shirts, pants, hats, and sunglasses

Other information

CLINICAL STUDIES SECTION

■ dermatologist and allergy tested

STORAGE AND HANDLING SECTION

■ protect this product from excessive heat and direct sun ■ do not store at temperatures below 32°F (0°C) or above 120°F (49°C)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

ammonium glycyrrhizate, beeswax, C12-15 alkyl benzoate, cetyl esters, paraffin, euphorbia cerifera (candillia) wax, flavor petrolatum USP, simmondsia chinensis (jojoba) seed oil, stearyl dimethicone, theobroma cacao (cocoa) seed butter, tocopheryl acetate (vitamin E USP)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cranberry Tangerine Lip BalmCranberry Tangerine Lip Balm

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54473-223-012025-04-07C16284748780-12cef2736-a294-d83d-e063-dadaa90ab31fSun Shades Lip Balm - Sunscreen Cranberry Tangerine - Broad-spectrum SPF 15
54473-223-012025-01-30C16284748780-12cef2736-a294-d83d-e063-dadaa90ab31fSun Shades Lip Balm - Sunscreen Cranberry Tangerine - Broad-spectrum SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-223-01Sun Shades Lip BalmCranberry Tangerine4.25 g in 1 TUBESTICK4.252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-223SUN SHADES LIP BALM CRANBERRY TANGERINE (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2Current NDC, 1 package rows20250409_f39606be-19c8-58d1-e053-2a95a90a908f.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54473-22354473-223-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
CERESINQ1LS2UJO3AIACT
CETYL ESTERS WAXD072FFP9GUIACT
COCOA BUTTER512OYT1CRRIACT
PARAFFINI9O0E3H2ZEIACT
JOJOBA OIL724GKU717MIACT
PETROLATUM4T6H12BN9UIACT
YELLOW WAX2ZA36H0S2VIACT
CANDELILLA WAXWL0328HX19IACT
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB

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
Sun Shades Lip Balm Cranberry TangerineAVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%Melaleuca Inc.f39606be-19c8-58d1-e053-2a95a90a908f2025-03-20WarningsExact identifier
ndc (package): 54473-223-01
ndc (product): 54473-223
ndc11 (package): 54473022301
spl id: 30ce1c87-335a-f0ee-e063-6394a90a01d5
spl set id: f39606be-19c8-58d1-e053-2a95a90a908f

Reported adverse events (FAERS/openFDA)#

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