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 62 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
e.l.f. Wake the E.L.F. Up Skincare Set	AVOBENZONE, OCTISALATE, OCTOCRYLENE, HOMOSALATE	e.l.f. Cosmetics, Inc	4b20c56a-3e91-3419-e063-6294a90ad361	2026-02-18	Warnings	Exact identifier application number: M020
Dermatone Mineral SPF 30	ZINC OXIDE 20%	Dermatone Labs LLC	26e3209f-cb5c-484e-9b2e-74dc397d4790	2026-02-18	Warnings	Exact identifier application number: M020
SHISEIDO ESSENTIAL ENERGY HYDRATING DAY	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	SHISEIDO AMERICAS CORPORATION	8b88039a-09fe-458b-b80f-49cde49b6595	2026-02-17	Warnings	Exact identifier application number: M020
cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED n	AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE	SHISEIDO AMERICAS CORPORATION	f3729d0b-e601-48bb-9907-1d6e3ab31996	2026-02-17	Warnings	Exact identifier application number: M020
Luminesce Daily Moisturizing Complex	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Velovita Inc.	4b0c2213-8667-be6f-e063-6394a90a5e86	2026-02-17	Warnings	Exact identifier application number: M020
Sport Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	Valu Merchandisers Company	e168f8e8-22d0-4a60-b9f9-dec9d0fab3f1	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M020
Sunscreen for Kids SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	Valu Merchandisers Company	cfc3b202-6511-450a-b3c1-2d8e8ebc070d	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M020
Sport Sunscreen SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE	Valu Merchandisers Company	5a8af0ea-b31c-456a-bc23-31e2473ca75a	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M020
Sparms 100% Organic Face Sunscreen	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	4ae6b187-142b-e4a6-e063-6294a90af365	2026-02-15	Warnings	Exact identifier application number: M020
Lotus Harmony - Quinn Shield Sunscreen SPF50	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	4ae73d23-1118-716c-e063-6394a90a68c7	2026-02-15	Warnings	Exact identifier application number: M020
Avebonzone, Homosalate, Octisalate	AVEBONZONE, HOMOSALATE, OCTISALATE	Amazon.com Services LLC	4ab542aa-bd05-ba7a-e063-6294a90ae584	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M020
Beauty Hydrating	HOMOSALATE, ZINC OXIDE	Topco Associates LLC	6e88ccc8-8576-4573-8a5b-28e64008a349	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M020
Wotnot Naturals Natural Zinc Sunscreen SPF 30	ZINC OXIDE	ECOdirect Pty Ltd (Trading as Wotnot Naturals)	4ab759ae-0c1c-bddc-e063-6394a90a1d09	2026-02-13	Warnings	Exact identifier application number: M020
Wotnot Naturals Natural Zinc Sunscreen SPF 30	ZINC OXIDE	ECOdirect Pty Ltd (Trading as Wotnot Naturals)	4ab83b34-9376-d169-e063-6394a90a18cd	2026-02-13	Warnings	Exact identifier application number: M020
Homosalate, Octisalate, Zinc oxide	HOMOSALATE, OCTISALATE, ZINC OXIDE	Topco Associates LLC	48fb9a3c-c058-ce71-e063-6294a90aaf1e	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M020
Ambi Even and Clear Facial Moisturizer	HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 3%, AVOBENZONE 3%	73453-112	469440e9-bf47-bebd-e063-6294a90acca2	2026-02-12	Warnings	Exact identifier application number: M020
Intelligent Defense Mineral Sunscreen	ZINC OXIDE	GLO PHARMA	4ab664aa-5f0c-7ddb-e063-6294a90a9753	2026-02-12	Warnings	Exact identifier application number: M020
Sky and Sol Sports Sunscreen	ZINC OXIDE	Delta Ecommerce LLC	4dd054cd-8f53-4210-e063-6394a90ade27	2026-02-12	Warnings	Exact identifier application number: M020
Sky and Sol Kids and Babies Sunscreen	ZINC OXIDE	Delta Ecommerce LLC	4de67653-ab31-c6b2-e063-6394a90a7e8c	2026-02-12	Warnings	Exact identifier application number: M020
Eva Claire Natural Professional Sunscreen	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Eva Claire Cosmetics Co., Ltd.	4a870452-cac2-4d2c-e063-6294a90abb07	2026-02-11	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