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 314 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 Deep	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	83725be5-4a0a-4717-a034-ff2999dd4099	2023-12-16	Warnings	Exact identifier application number: M020
Light Day Sunscreen SPF 37	AVOBENZONE, OCTINOXATE, OCTOCRYLENE	Circadia by Dr Pugliese, Inc.	16d76785-22a0-4a4b-a6f1-74056612e936	2023-12-15	Warnings	Exact identifier application number: M020
ERBORIAN - BB CREME NUDE SPF20	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	337a771e-c965-421a-a8e7-d853ffe51c2c	2023-12-15	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 Medium	TITANIUM DIOXIDE AND ZINC OXIDE	Cosmetique Active Production	b4cef09a-f0e4-4054-a200-667df7d150bf	2023-12-15	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 Medium	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	1f3b56d5-c33a-401f-8c8a-924345a4846e	2023-12-15	Warnings	Exact identifier application number: M020
Rejuvity moisturizing day cream BROAD SPECTRUM SPF 15 SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	Isagenix International, LLC	6d2d5590-5f53-48d9-94c5-fe9f6a5cf3ce	2023-12-14	Warnings	Exact identifier application number: M020
bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Fair 01	TITANIUM DIOXIDE	Orveon Global US LLC	29738578-6681-476e-8660-7219f58e8fa0	2023-12-13	Warnings	Exact identifier application number: M020
Sheer Mineral Sunscreen Broad Spectrum SPF 30	ZINC OXIDE	Allure Labs	0c6ac094-cb5b-0f09-e063-6394a90a9eed	2023-12-13	Warnings	Exact identifier application number: M020
REDEFINE Triple Defense	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Rodan & Fields	ed0209a6-a8ce-4394-bcf0-32d585a6b834	2023-12-13	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Ultra Light Broad Spectrum SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Cosmetique Active Production	4e56f3f2-b856-4bbc-ab39-6fb5887a4846	2023-12-13	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Ultra Light Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	2ce83dc2-84b6-43fd-8b11-495d41cebc22	2023-12-13	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Face Broad Spectrum SPF 50 Sunscreen	TITANIUM DIOXIDE	Cosmetique Active Production	4d5d1e79-7b3e-41b5-ae6b-a3b0265702ca	2023-12-13	Warnings	Exact identifier application number: M020
6000X Elemental Screen BS SPF 30 Sunscreen	ZINC OXIDE	Allure Labs	0c574a9a-edea-d333-e063-6394a90a41e3	2023-12-12	Warnings	Exact identifier application number: M020
RODAN FIELDS SOOTHE 4 Mineral Sunscreen BROAD SPECTRUM SPF 30	TITANIUM DIOXIDE	Rodan & Fields	1a936053-2be0-4c52-a073-ba846b87f811	2023-12-12	Warnings	Exact identifier application number: M020
Beet the sun lightweight sunscreen broad spectrum spf 40 pa	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Krave Beauty, LLC	ff93d086-ec80-6bd5-e053-6294a90af019	2023-12-12	Warnings	Exact identifier application number: M020
Broad Spectrum SPF 30 Up The Anti	TITANIUM DIOXIDE, ZINC OXIDE	Biopelle, Inc.	37506766-370e-4ae4-8dbe-915a763e7c55	2023-12-12	Warnings	Exact identifier application number: M020
INTELLIGENT BEAUTY LABS Age Defying Day Broad Spectrum SPF 20	AVOBENZONE, OCTINOXATE, OCTISALATE	DermStore, LLC	19640e0c-c6b3-43b8-91e9-d8d9fff2e44e	2023-12-12	Warnings	Exact identifier application number: M020
Dr. Perrys Day Thyme SPF 20 Broad Spectrum Sunscreen	ZINC OXIDE	Englewood Lab, Inc.	273d8e30-a6bc-4b26-919c-9332fd5197fa	2023-12-12	Warnings	Exact identifier application number: M020
Youth Activating BB SPF30 Shade 3	ZINC OXIDE, TITANIUM DIOXIDE	Englewood Lab, Inc.	c84207c4-a779-4c00-a486-86eaf8ece169	2023-12-12	Warnings	Exact identifier application number: M020
Rodan and Fields ESSENTIALS Lip Shield Broad Spectrum SPF 25	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Rodan & Fields	c7526b69-d059-499a-9134-3a1f5d0471b3	2023-12-12	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