Sun Shades Lip Balm

Product NDC: 54473-226
Requested package NDC: 54473-226-04
11-digit product format: 544730226
Labeler code: 54473
Product ID: 54473-226_4747c8ff-53eb-ef14-e063-6294a90ae4e0
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%
Dosage form: STICK
Route: TOPICAL
Labeler: Melaleuca Inc.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-02-01
Substance: AVOBENZONE; OCTINOXATE; OXYBENZONE
Active strength: .1175; .282; .141 g/4.25g; g/4.25g; g/4.25g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Sun Shades Lip Balm
Brand name suffix: Pina Colada
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AVOBENZONE	.1175 g/4.25g
OCTINOXATE	.282 g/4.25g
OXYBENZONE	.141 g/4.25g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G63QQF2NOX	Internal UNII lookup
4Y5P7MUD51	Internal UNII lookup
95OOS7VE0Y	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
16d0d2d2-b9c4-4491-8d8a-815843d342e8	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54473-226-04	2020-03-19	C162847	48780-1	9d75b9d0-7def-f424-e053-dadaa90a57ce	Sun Shades Lip Balm - Sunscreen Pina Colada - Broad-spectrum SPF 15
54473-226-04	2020-01-31	C162847	48780-1	9d75b9d0-7def-f424-e053-dadaa90a57ce	Sun Shades Lip Balm - Sunscreen Pina Colada - Broad-spectrum SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54473-226-04	Sun Shades Lip BalmPina Colada	4.25 g in 1 TUBE	STICK	4.25		7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]	2
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]	2
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]	2
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]	2
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]	2
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]	2
ALKYL (C12-15) BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]	2
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]	2
AMMONIUM GLYCYRRHIZATE	INACTIVE INGREDIENT	3VRD35U26C	SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]	2
CANDELILLA WAX	INACTIVE INGREDIENT	WL0328HX19	SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]	2
CERESIN	INACTIVE INGREDIENT	Q1LS2UJO3A	SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]	2
CETYL ESTERS WAX	INACTIVE INGREDIENT	D072FFP9GU	SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]	2
COCOA BUTTER	INACTIVE INGREDIENT	512OYT1CRR	SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]	2
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)	INACTIVE INGREDIENT	L5F16ZG4ZU	SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]	2
JOJOBA OIL	INACTIVE INGREDIENT	724GKU717M	SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]	2
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]	2
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54473-226	SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]	6	Current NDC, Legacy NDC, 1 package rows	20240918_16d0d2d2-b9c4-4491-8d8a-815843d342e8.zip

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 359 · 7,165 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NeoStrata Skin Active Matrix Support SPF 30	AVOBENZONE, OCTINOXATE, AND OCTISALATE	NeoStrata Company Inc.	8e4b9c08-b906-4c5f-a243-55838ae28b90	2026-07-29	Warnings	Exact identifier application number: M020
Exuviance Age Reverse Day Repair with Sunscreen Broad Spectrum SPF 30	AVOBENZONE, OCTINOXATE, AND OCTISALATE	NeoStrata Company Inc.	4739e678-ce51-4863-bb74-2275879e1b47	2026-07-29	Warnings	Exact identifier application number: M020
MELAO GHK-Cu PEPTIDE SUNSCREEN	BUTYL METHOXYDIBENZOYLMETHANE,ETHYLHEXYL SALICYLATE,HOMOSALATE,OCTOCRYLENE	Guangdong Aimu Biological Technology Co., Ltd	57a8c34a-d6c9-c03e-e063-6394a90a7af1	2026-07-29	Warnings	Exact identifier application number: M020
BelleJoss BROAD SPECTRUM SPF 50	BROAD SPECTRUM SPF 50	Guangzhou Liyan Cosmetics Technology Co., Ltd.	57c07f29-2e23-d18a-e063-6394a90a1020	2026-07-29	Warnings	Exact identifier application number: M020
BemeJolie BROAD SPECTRUM SPF 50	BROAD SPECTRUM SPF 50	Guangzhou Liyan Cosmetics Technology Co., Ltd.	57c27cea-bb0c-5d2d-e063-6394a90a1b48	2026-07-29	Warnings	Exact identifier application number: M020
Native Mineral Suncare Broad Spectrum SPF 30 Unscented	ZINC OXIDE	The Procter & Gamble Manufacturing Company	3a89238b-d1ee-d7fa-e063-6294a90ae55f	2026-07-28	Warnings	Exact identifier application number: M020
First Aid Beauty FAB Mineral Sunscreen Broad Spectrum SPF 30	ZINC OXIDE	The Procter & Gamble Manufacturing Company	dfb1b42e-c821-1a41-e053-2995a90acf95	2026-07-28	Warnings	Exact identifier application number: M020
LUXE COLOR FOUNDATION	OCTINOXATE 7% ZINC OXIDE 5%	Guangzhou Huixue Biotechnology Co., Ltd.	576c3496-702f-808c-e063-6394a90a53c3	2026-07-25	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Day Cream Sunscreen Broad Spectrum SPF 25 Kit	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Xact Packing Limited	5759058d-e683-f3fc-e063-6394a90abc01	2026-07-24	Warnings	Exact identifier application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 LIGHT	ZINC OXIDE	Younique, LLC	f93d42a9-b655-4b75-a16d-b29f38f04efc	2026-07-23	Warnings	Exact identifier application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 LIGHT MEDIUM	ZINC OXIDE	Younique, LLC	82769819-b229-4864-9b3c-44f49a68a53a	2026-07-23	Warnings	Exact identifier application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 FAIR	ZINC OXIDE	Younique, LLC	ed700cae-8226-48d9-93ba-03154aa1cae5	2026-07-23	Warnings	Exact identifier application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 FAIR LIGHT	ZINC OXIDE	Younique, LLC	d728b89c-692f-485b-88c3-929b2f0350d5	2026-07-23	Warnings	Exact identifier application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 MEDIUM	ZINC OXIDE	Younique, LLC	a49dfff1-e9ec-4573-90b0-ef6a7226aa56	2026-07-23	Warnings	Exact identifier application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 MEDIUM DARK	ZINC OXIDE	Younique, LLC	cc576b63-caf4-491d-8d7f-027b1127133b	2026-07-23	Warnings	Exact identifier application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 DARK	ZINC OXIDE	Younique, LLC	2173666b-6c72-449d-9f40-098ea174f3e1	2026-07-23	Warnings	Exact identifier application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 DARK DEEP	ZINC OXIDE	Younique, LLC	360ceb90-bec6-4fec-820a-a4d65008b872	2026-07-23	Warnings	Exact identifier application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 DEEP	ZINC OXIDE	Younique, LLC	86c33a9e-9132-4377-8688-41e5844de62c	2026-07-23	Warnings	Exact identifier application number: M020
MENOKIN 30 SECONDS GLOW AND CLEAR Gel SUNSCREEN MOISTURE	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Forest Avenue Co., Ltd.	edbfcf21-96c6-4519-8b08-f9b5ada7d1d7	2026-07-23	Warnings	Exact identifier application number: M020
SKINSUIT LIP SPF 30	ZINC OXIDE	Skin Authority LLC	cb24d714-f6cd-4518-b146-627cfe6c2ccd	2026-07-23	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54473-226-04	54473022604	4.25 g in 1 TUBE (54473-226-04)	4.25 g	2018-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sun Shades Lip Balm - Sunscreen Pina Colada - Broad-spectrum SPF 15	Melaleuca Inc.	2025-12-31	HUMAN OTC DRUG LABEL	7