Sun Shades Lip Balm

Manufacturer: Melaleuca, Inc.
Effective date: 2010-12-15
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:26:41

Label at a glance#

ProductSun Shades Lip Balm Pomegranate SPF 15

Active ingredientOctinoxate, Oxybenzone

Label structure6 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Octinoxate 7.5% w/w, Oxybenzone 3% w/w.

OTC - PURPOSE SECTION

Uses: Helps protect against sunburn.

WARNINGS SECTION

Warnings: Keep out of eyes. Stop use if skin rash/irritation occurs. Keep out of reach of children.

OTC - WHEN USING SECTION

Directions: Apply to the lips prior to sun exposure or as needed.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Petrolatum USP, Jojoba Oil, Beeswax, Cetyl Esters, Ozokerite, Cocoa Butter, Stearyl Dimethicone, Flavor, Tocopheryl Acetate (Vitamin E USP), Monoammonium Glycyrrhizinate, Ethylene/VA Copolymer.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54473-168-01	2019-10-29	C162847	48780-1	960f7f55-c617-8e05-e053-dbdaa90a074a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54473-168-01	Sun Shades Lip Balm Pomegranate SPF 15	4.2 g in 1 APPLICATOR	STICK	4.2		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54473-168	SUN SHADES LIP BALM (OCTINOXATE AND OXYBENZONE) STICK [MELALEUCA, INC.]	2	Legacy NDC, 1 package rows	20101220_5bc60cf9-675e-4cfe-b96e-40a349705af8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	2
Oxybenzone	ACTIVE INGREDIENT	95OOS7VE0Y	2
Octinoxate	ACTIVE MOIETY	4Y5P7MUD51	2
Oxybenzone	ACTIVE MOIETY	95OOS7VE0Y	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
Glycyrrhizin, Ammoniated	INACTIVE INGREDIENT	3VRD35U26C	2
Jojoba Oil	INACTIVE INGREDIENT	724GKU717M	2
Petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	2
Vitamin E Acetate	INACTIVE INGREDIENT	9E8X80D2L0	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 · 13 matching rows.

Sun Shades Lip Balm Pomegranate SPF 15
Octinoxate and Oxybenzone
Octinoxate
Oxybenzone
Petrolatum
Jojoba Oil
Yellow Wax
Cetyl Esters Wax
Ceresin
Cocoa Butter
Vitamin E Acetate
Glycyrrhizin, Ammoniated
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54473-168	54473-168-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Octinoxate	4Y5P7MUD51	ACTIB
Oxybenzone	95OOS7VE0Y	ACTIB
Petrolatum	4T6H12BN9U	IACT
Jojoba Oil	724GKU717M	IACT
Yellow Wax	2ZA36H0S2V	IACT
Cetyl Esters Wax	D072FFP9GU	IACT
Ceresin	Q1LS2UJO3A	IACT
Cocoa Butter	512OYT1CRR	IACT
Vitamin E Acetate	9E8X80D2L0	IACT
Glycyrrhizin, Ammoniated	3VRD35U26C	IACT
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)	L5F16ZG4ZU	IACT

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 · 38 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Petrolatum	PETROLATUM	4T6H12BN9U	CAPSULE / VAGINAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	LIQUID / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / OPHTHALMIC	88.4 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Yellow Wax	YELLOW WAX	2ZA36H0S2V	TABLET, COATED / ORAL	213.7 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
Ceresin	CERESIN	Q1LS2UJO3A	OINTMENT / TOPICAL		1097 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
Yellow Wax	YELLOW WAX	2ZA36H0S2V	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
Vitamin E Acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
Yellow Wax	YELLOW WAX	2ZA36H0S2V	TABLET, DELAYED RELEASE / ORAL	0.1 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	CREAM, AUGMENTED / TOPICAL	26 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	SUPPOSITORY / VAGINAL	27 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	TABLET / ORAL	3.5 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
Vitamin E Acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
Yellow Wax	YELLOW WAX	2ZA36H0S2V	CREAM / TOPICAL	5 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
Yellow Wax	YELLOW WAX	2ZA36H0S2V	TABLET, EXTENDED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	SOAP / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Yellow Wax	YELLOW WAX	2ZA36H0S2V	CAPSULE / ORAL		44 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
Cetyl Esters Wax	CETYL ESTERS WAX	D072FFP9GU	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
Yellow Wax	YELLOW WAX	2ZA36H0S2V	CAPSULE, EXTENDED RELEASE / ORAL	80.67 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Cetyl Esters Wax	CETYL ESTERS WAX	D072FFP9GU	CREAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	TABLET, EXTENDED RELEASE / ORAL	0.18 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT, AUGMENTED / TOPICAL	81.94 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Vitamin E Acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	CAPSULE, EXTENDED RELEASE / ORAL	0.07 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
Cetyl Esters Wax	CETYL ESTERS WAX	D072FFP9GU	CREAM / TOPICAL	10.3 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
Cetyl Esters Wax	CETYL ESTERS WAX	D072FFP9GU	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
Yellow Wax	YELLOW WAX	2ZA36H0S2V	OINTMENT / TOPICAL	20 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
Cocoa Butter	COCOA BUTTER	512OYT1CRR	SUPPOSITORY / RECTAL	2280 mg		Exact identifier — unii candidate
Cetyl Esters Wax	CETYL ESTERS WAX	D072FFP9GU	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	EMULSION / TOPICAL	7.8 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / VAGINAL		4084 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
Yellow Wax	YELLOW WAX	2ZA36H0S2V	TABLET / ORAL	3.22 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
Ceresin	CERESIN	Q1LS2UJO3A	CREAM / VAGINAL		280 mg	Exact identifier — unii candidate 2 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
967dad22-e802-4c24-86ea-a24a0297a4a7			5bc60cf9-675e-4cfe-b96e-40a349705af8	2010-12-15	Warnings	Exact identifier spl id: 967dad22-e802-4c24-86ea-a24a0297a4a7 spl set id: 5bc60cf9-675e-4cfe-b96e-40a349705af8

Reported adverse events (FAERS/openFDA)#

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