Sun Shades Lip Balm

Manufacturer: Melaleuca Inc.
Effective date: 2025-12-31
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-06-01 01:29:53

Label at a glance#

ProductSun Shades Lip Balm Vanilla Bean

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

petrolatum USP, beeswax, simmondsia chinensis (jojoba) seed oil, euphorbia cerifera (candelilla) wax, cetyl esters, theobroma cacao (cocoa) seed butter, flavor, C12-15 alkyl benzoate, stearyl dimethicone, tocopheryl acetate (vitamin E USP), ethylene/VA copolymer, ammonium glycrrhizate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sun Shades Lip Balm Vanilla Bean label.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54473-219-04	2020-03-19	C162847	48780-1	9d75b9cf-f998-f424-e053-dadaa90a57ce	Sun Shades Lip Balm - Sunscreen Vanilla Bean - Broad-spectrum SPF 15
54473-219-04	2020-01-31	C162847	48780-1	9d75b9cf-f998-f424-e053-dadaa90a57ce	Sun Shades Lip Balm - Sunscreen Vanilla Bean - Broad-spectrum SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54473-219-04	Sun Shades Lip BalmVanilla Bean	4.25 g in 1 APPLICATOR	STICK	4.25		8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	2
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	2
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	2
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	2
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	2
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	2
ALKYL (C12-15) BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	2
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	2
AMMONIUM GLYCYRRHIZATE	INACTIVE INGREDIENT	3VRD35U26C	2
CANDELILLA WAX	INACTIVE INGREDIENT	WL0328HX19	2
CERESIN	INACTIVE INGREDIENT	Q1LS2UJO3A	2
CETYL ESTERS WAX	INACTIVE INGREDIENT	D072FFP9GU	2
COCOA BUTTER	INACTIVE INGREDIENT	512OYT1CRR	2
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)	INACTIVE INGREDIENT	L5F16ZG4ZU	2
JOJOBA OIL	INACTIVE INGREDIENT	724GKU717M	2
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	2
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	2

Products#

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

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

Sun Shades Lip Balm Vanilla Bean
Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%
ALKYL (C12-15) BENZOATE
ALPHA-TOCOPHEROL ACETATE
AMMONIUM GLYCYRRHIZATE
CERESIN
CETYL ESTERS WAX
COCOA BUTTER
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)
JOJOBA OIL
PETROLATUM
YELLOW WAX
CANDELILLA WAX
AVOBENZONE
OCTINOXATE
OXYBENZONE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54473-219	54473-219-04

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
Name	UNII	Kind
ALKYL (C12-15) BENZOATE	A9EJ3J61HQ	IACT
ALPHA-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
AMMONIUM GLYCYRRHIZATE	3VRD35U26C	IACT
CERESIN	Q1LS2UJO3A	IACT
CETYL ESTERS WAX	D072FFP9GU	IACT
COCOA BUTTER	512OYT1CRR	IACT
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)	L5F16ZG4ZU	IACT
JOJOBA OIL	724GKU717M	IACT
PETROLATUM	4T6H12BN9U	IACT
YELLOW WAX	2ZA36H0S2V	IACT
CANDELILLA WAX	WL0328HX19	IACT
AVOBENZONE	G63QQF2NOX	ACTIB
OCTINOXATE	4Y5P7MUD51	ACTIB
OXYBENZONE	95OOS7VE0Y	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 44 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CANDELILLA WAX	CANDELILLA WAX	WL0328HX19	TABLET / ORAL		4 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		Exact identifier — unii+route 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SOAP / TOPICAL	0.85 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	CREAM / TOPICAL	5 %w/w		Exact identifier — unii+route 4 equally ranked IID candidates
CETYL ESTERS WAX	CETYL ESTERS WAX	D072FFP9GU	CREAM / TOPICAL	10.3 %w/w		Exact identifier — unii+route 4 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii+route 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii+route 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT, AUGMENTED / TOPICAL	81.94 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
CETYL ESTERS WAX	CETYL ESTERS WAX	D072FFP9GU	LOTION / TOPICAL	1 %w/w		Exact identifier — unii+route 4 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	EMULSION / TOPICAL	7.8 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
CANDELILLA WAX	CANDELILLA WAX	WL0328HX19	TABLET, DELAYED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
CANDELILLA WAX	CANDELILLA WAX	WL0328HX19	TABLET, DELAYED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
CANDELILLA WAX	CANDELILLA WAX	WL0328HX19	TABLET / ORAL		4 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM, AUGMENTED / TOPICAL	26 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
CANDELILLA WAX	CANDELILLA WAX	WL0328HX19	TABLET, FILM COATED / ORAL	0.8 mg		Exact identifier — unii candidate 8 equally ranked IID candidates
CETYL ESTERS WAX	CETYL ESTERS WAX	D072FFP9GU	LOTION / TOPICAL	1 %w/w		Exact identifier — unii+route 4 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT, AUGMENTED / TOPICAL	81.94 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	CREAM / TOPICAL	5 %w/w		Exact identifier — unii+route 4 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
COCOA BUTTER	COCOA BUTTER	512OYT1CRR	SUPPOSITORY / RECTAL	2280 mg		Exact identifier — unii candidate 2 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	OINTMENT / TOPICAL	20 %w/w		Exact identifier — unii+route 4 equally ranked IID candidates
CERESIN	CERESIN	Q1LS2UJO3A	OINTMENT / TOPICAL		1097 mg	Exact identifier — unii+route 2 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii+route 18 equally ranked IID candidates
CANDELILLA WAX	CANDELILLA WAX	WL0328HX19	TABLET, EXTENDED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	OINTMENT / TOPICAL	20 %w/w		Exact identifier — unii+route 4 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		Exact identifier — unii+route 18 equally ranked IID candidates
COCOA BUTTER	COCOA BUTTER	512OYT1CRR	SUPPOSITORY / RECTAL	2280 mg		Exact identifier — unii candidate 2 equally ranked IID candidates
CERESIN	CERESIN	Q1LS2UJO3A	OINTMENT / TOPICAL		1097 mg	Exact identifier — unii+route 2 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	EMULSION / TOPICAL	7.8 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
CANDELILLA WAX	CANDELILLA WAX	WL0328HX19	TABLET, FILM COATED / ORAL	0.8 mg		Exact identifier — unii candidate 8 equally ranked IID candidates
CANDELILLA WAX	CANDELILLA WAX	WL0328HX19	TABLET, EXTENDED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM, AUGMENTED / TOPICAL	26 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SOAP / TOPICAL	0.85 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii+route 18 equally ranked IID candidates
CETYL ESTERS WAX	CETYL ESTERS WAX	D072FFP9GU	CREAM / TOPICAL	10.3 %w/w		Exact identifier — unii+route 4 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sun Shades Lip Balm Vanilla Bean	AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%	Melaleuca Inc.	2037cc9d-b11b-47d6-8d65-c0f9decc8ba7	2025-12-31	Warnings	Exact identifier ndc (package): 54473-219-04 ndc (product): 54473-219 ndc11 (package): 54473021904 spl id: 4747dd7a-f696-e18e-e063-6394a90a46c3 spl set id: 2037cc9d-b11b-47d6-8d65-c0f9decc8ba7

Reported adverse events (FAERS/openFDA)#

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