Petroleum-Free Lip Balm

Product NDC: 53329-092
11-digit product format: 533290092
Labeler code: 53329
Product ID: 53329-092_40c101e4-f9c5-4766-e063-6294a90aaa46
Type: HUMAN OTC DRUG
Nonproprietary name: Octinoxate and Oxybenzone
Dosage form: LIPSTICK
Route: TOPICAL
Labeler: Medline Industries, LP
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2010-04-01
Substance: OCTINOXATE; OXYBENZONE
Active strength: 2; 4.5 g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product	53329-092		I	Inactivated by FDA		excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53329-092	53329-092-83	I	Inactivated by FDA		excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Petroleum-Free Lip Balm
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTINOXATE	2 g/100g
OXYBENZONE	4.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
6125d98a-6fc7-4f50-924e-3b1f7ee951f4	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2023-08-08	092 Curad Petroleum-Free Lip Balm
2023-08-08	092 Curad Petroleum-Free Lip Balm
2023-07-28	092 Curad Petroleum-Free Lip Balm
2023-07-28	092 Curad Petroleum-Free Lip Balm
2022-09-27	092 Curad Petroleum-Free Lip Balm
2022-09-27	092 Curad Petroleum-Free Lip Balm
2022-07-29	092 Curad Petroleum-Free Lip Balm
2022-07-29	092 Curad Petroleum-Free Lip Balm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53329-092-83	Petroleum-Free Lip Balm	4.2 g in 1 CONTAINER	LIPSTICK	4.2		8
53329-092-83	Petroleum-Free Lip Balm	1 in 1 BOX	LIPSTICK	1		8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
COCONUT OIL	INACTIVE INGREDIENT	Q9L0O73W7L	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
CORN OIL	INACTIVE INGREDIENT	8470G57WFM	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
TEA TREE OIL	INACTIVE INGREDIENT	VIF565UC2G	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-092	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, LP]	7	Current NDC, Legacy NDC, 2 package rows	20241204_6125d98a-6fc7-4f50-924e-3b1f7ee951f4.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 227 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BANANA BOAT	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	2ee9b3dc-91cd-1af9-e063-6394a90a78e1	2025-02-24	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	2edc79f8-aac5-15eb-e063-6394a90a9736	2025-02-23	Warnings	Exact identifier application number: M020
CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 AVELLANA 270-C	OCTINOXATE, ZINC OXIDE	BEL STAR S A	dc25651b-0e30-c325-e053-2995a90a809e	2025-02-21	Warnings	Exact identifier application number: M020
CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 AZUCAR BLANCA 110-C	OCTINOXATE, ZINC OXIDE	BEL STAR S A	dc129cd6-a173-d2b3-e053-2a95a90aa04e	2025-02-21	Warnings	Exact identifier application number: M020
COOLA Classic Liplux Lip Balm SPF 30 Tinted	AVOBENZONE, OCTISALATE, OCTOCRYLENE	COOLA, LLC	eec6e7c8-17fe-f34b-e053-2995a90a78a0	2025-02-20	Warnings	Exact identifier application number: M020
Drops	AVOBENZONE OCTISALATE OCTOCRYLENE	Vacation Inc.	1319d6ea-a580-79c5-e063-6394a90a4dca	2025-02-20	Warnings	Exact identifier application number: M020
Vacation SPF 50 Super Spritz Face Mist	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Vacation Inc.	f67fbe98-93ce-2882-e053-2a95a90ab713	2025-02-20	Warnings	Exact identifier application number: M020
REPAIRWEAR UPLIFTING FIRMING BROAD SPECTUM SPF 15 - NORMAL COMBO TO COMBINATION oily	OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE	CLINIQUE LABORATORIES LLC	10edc0c1-9359-4c7a-a56e-bad06fea0056	2025-02-20	Warnings	Exact identifier application number: M020
Mineral SPF 30 Brush-On Sun Defense	ZINC OXIDE	Mineral Fusion	29733dba-8824-461e-be44-335d6fe50d60	2025-02-19	Warnings	Exact identifier application number: M020
Neutrogena Healthy Skin Invisibly Radiant UV Primer SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Kenvue Brands LLC	20cd4d96-2046-3a50-e063-6394a90a1219	2025-02-18	Warnings	Exact identifier application number: M020
COOLA Classic Body SPF 30 Pina Colada	AVOBENZONE, OCTISALATE, OCTOCRYLENE	COOLA, LLC	edc59de7-c817-1a59-e053-2995a90a3408	2025-02-17	Warnings	Exact identifier application number: M020
Liplux SPF 30 Lip Balm	CLASSIC	COOLA LLC	b47b5f3a-43f3-ae7a-e053-2995a90ae16d	2025-02-17	Warnings	Exact identifier application number: M020
COOLA Classic Body SPF 50 Fragrance Free	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COOLA, LLC	ed207afe-0b10-74c7-e053-2a95a90a9b87	2025-02-17	Warnings	Exact identifier application number: M020
Avon Skin-So-Soft Bug Guard plus SPF 30 Sunscreen Gentle Breeze Insect Repellent Sunscreen	OCTINOXATE, OXYBENZONE, OCTISALATE	The Avon Company	2e5d6c93-f091-5388-e063-6394a90ad560	2025-02-17	Warnings	Exact identifier application number: M020
KEYS SOULCARE DAILY MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc	31a98dc7-4b99-d845-e063-6394a90a2670	2025-02-17	Warnings	Exact identifier application number: M020
Ultra sheer mineral sunscreen PRO SPF30	ZINC OXIDE	Eden Brands Inc.	2ce06566-2eb0-9a00-e063-6394a90a9ba9	2025-02-14	Warnings	Exact identifier application number: M020
Cell Fusion C Laser UV Defense Sunscreen Broad Spectrum SPF 50	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	CMS LAB Inc.	2dff0386-e151-089a-e063-6394a90a0f53	2025-02-14	Warnings	Exact identifier application number: M020
Cell Fusion C Airy Stick Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CMS LAB Inc.	2dffc699-3b56-2c70-e063-6294a90ae249	2025-02-14	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Sheer)	ZINC OXIDE, TITANIUM DIOXIDE	Eminence Organic Skin Care	2e2082aa-5ae3-2c04-e063-6294a90a140b	2025-02-14	Warnings	Exact identifier application number: M020
Coola SPF 30 Mineral Sunscreen Fragrance Free	ZINC OXIDE	COOLA, LLC	edc6048e-0ea0-41c5-e053-2a95a90a96d9	2025-02-14	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
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
53329-092-83	53329009283	1 CONTAINER in 1 BOX (53329-092-83) / 4.2 g in 1 CONTAINER	1 container	2010-04-01	0000-00-00	No	No	Current