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 48 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Simple Mineral Sunscreen SPF 50	ZINC OXIDE	Simple Sunscreen LLC	c38cb4fa-8b8d-4c2d-9c32-301e120db1a1	2026-04-06	Warnings	Exact identifier application number: M020
Badger SPF 50 Adventure Sport Mineral Sunscreen Cream	ZINC OXIDE	W.S. Badger Company, Inc.	2a96c423-f4ad-0f07-e063-6394a90a39f8	2026-04-06	Warnings	Exact identifier application number: M020
Sheer Touch Sunscreen SPF 55	AVOBENZONE, HOMOSALATE, OCTISALATE	Amazon.com Services LLC	03fce792-bcbb-4848-bc87-8913ecbe0786	2026-04-06	Warnings, Adverse reactions	Exact identifier application number: M020
Sport Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	Amazon.com Services LLC	8937705d-b745-4b8c-bf9b-89e64a1e52b1	2026-04-06	Warnings, Adverse reactions	Exact identifier application number: M020
Avebonzone, Homosalate, Octisalate	AVEBONZONE, HOMOSALATE, OCTISALATE	Amazon.com Services LLC	4ab6773f-00e1-897a-e063-6294a90ab0b8	2026-04-06	Warnings, Adverse reactions	Exact identifier application number: M020
Principal Secret Revolutionary Anti-Aging Broad Spectrum SPF 15	AVOBENZONE, OCTINOXATE, OCTISALATE, AND OCTOCRYLENE	Guthy-Renker LLC	eb1a9b67-b9e2-41f8-bc6d-df94b6a33ab8	2026-04-06	Warnings	Exact identifier application number: M020
TIRTIR HYDRO UV SHIELD SUNSCREEN SPF50 BROAD SPECTRUM	HOMOSALATE, AVOBENZONE, OCTISALATE, OCTOCRYLENE	TIRTIR USA Inc.	4ec04105-e54f-a82e-e063-6394a90a6c5a	2026-04-05	Warnings	Exact identifier application number: M020
PRVWORA Ultra Defense Sunscreen	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Cellarkbio Inc.	50cf1d88-3e7e-47b7-816a-3d579bde0a6a	2026-04-04	Warnings	Exact identifier application number: M020
EltaMD UV Shield SPF45	ZINC OXIDE AND OCTINOXATE SUNSCREEN	CP Skin Health Group, Inc.	7c49f971-d425-4be9-a665-5cd218b7f945	2026-04-03	Warnings	Exact identifier application number: M020
Jack Black	AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM	Jack Black L.L.C.	4baade5c-e759-d98f-e063-6394a90aa056	2026-04-03	Warnings	Exact identifier application number: M020
Vacation SPF 30 ClassicSpray	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Vacation Inc.	da43d71d-733b-5700-e053-2a95a90a5dca	2026-04-03	Warnings	Exact identifier application number: M020
Warriors Crown Sentinel Zinc Defense Sunscreen SPF 30	ZINC OXIDE	Allure Labs	4e93e64a-97ab-e0a5-e063-6294a90ad950	2026-04-03	Warnings	Exact identifier application number: M020
Pro-Collagen Marine Broad Spectrum SPF 30	AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE	ELEMIS Limited	3321281e-612b-4305-bf6d-bfab02c65ffb	2026-04-03	Warnings	Exact identifier application number: M020
EltaMD Skincare UV AOX Elements SPF50 Tinted	TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN	CP Skin Health Group, Inc	2c74209d-9b88-4c32-ad42-cd6de16c1fef	2026-04-03	Warnings	Exact identifier application number: M020
EltaMD UV Restore Tinted	TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREEN	CP Skin Health Group, Inc	4fc18856-01b3-43ed-9e1b-b4394e31aa3c	2026-04-03	Warnings	Exact identifier application number: M020
Sunscreen for baby SPF50plus	OCTOCRYLENE,ETHYLHEXYL METHOXYCINNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATE	Guangzhou Senmai Biotechnology Co., Ltd.	1cb7fbca-0874-ae53-e063-6294a90ab42a	2026-04-02	Warnings	Exact identifier application number: M020
TiZO3	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	4e7bdec2-abcc-0267-e063-6394a90ae47a	2026-04-02	Warnings	Exact identifier application number: M020
TIZO PHOTOCEUTICAL AM REPLENISH - TINTED	ZINC OXIDE	Fallien Cosmeceuticals, LTD	4e7c4702-5707-6c3e-e063-6394a90a05fd	2026-04-02	Warnings	Exact identifier application number: M020
Ilia Sun Serum Mineral Sunscreen SPF 50 Light Medium	ZINC OXIDE	Ilia, Inc.	4e7cc73c-d6c9-ecb0-e063-6394a90a922c	2026-04-02	Warnings	Exact identifier application number: M020
EltaMD UV Restore	TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN	CP Skin Health Group, Inc	17b47994-82d6-4f9d-8249-bdb55106c9b3	2026-04-02	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