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 47 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neutrogena MINERAL UV TINT FACE LIGHT SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Acupac Packaging, Inc.	4ef4a822-a7ab-b374-e063-6394a90a8508	2026-04-08	Warnings	Exact identifier application number: M020
Neutrogena MINERAL UV TINT FACE MEDIUM SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Acupac Packaging, Inc.	4ef4d44e-3421-535f-e063-6294a90a2fea	2026-04-08	Warnings	Exact identifier application number: M020
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30 and Neutrogena Collagen Bank Moisturizer	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Acupac Packaging, Inc.	4ef5baf7-00b1-97aa-e063-6294a90aab9c	2026-04-08	Warnings	Exact identifier application number: M020
Neutrogena Mineral Ultra Sheer Face SPF 70	TITANIUM DIOXIDE, ZINC OXIDE	Acupac Packaging, Inc.	4ef5dcd4-b2d0-bcd1-e063-6294a90a871f	2026-04-08	Warnings	Exact identifier application number: M020
Neutrogena Ultra Gentle Daily Facial Moisturizer Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Acupac Packaging, Inc.	4ef669b9-df00-8965-e063-6394a90ab335	2026-04-08	Warnings	Exact identifier application number: M020
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Acupac Packaging, Inc.	4ef6a60a-6634-e79b-e063-6394a90a3daa	2026-04-08	Warnings	Exact identifier application number: M020
Neutrogena Mineral Invisible Daily Defense Face Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Acupac Packaging, Inc.	4ef6b5fb-5495-001c-e063-6394a90ab7b3	2026-04-08	Warnings	Exact identifier application number: M020
Sunright Lip Balm	OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE	NSE Products, Inc.	dfdb2d0a-c646-4c44-b648-e2fdd604cdc9	2026-04-08	Warnings	Exact identifier application number: M020
Nu Colour Bioadaptive BB Plus Foundation - Light Golden	TITANIUM DIOXIDE	NSE Products, Inc.	faae6f47-19f3-41cb-8e0d-388569b5c73d	2026-04-07	Warnings	Exact identifier application number: M020
Ultra Sunscreen	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE	Jiangsu Senwo Medical Technology Co., Ltd.	4ed974b8-6c11-08e0-e063-6294a90a7713	2026-04-07	Warnings	Exact identifier application number: M020
Vivaiodays SPF 30 Sunscreen with Turmeric	SPF 30 SUNSCREEN WITH TURMERIC	5SENCO INC	4ee0c93a-7f50-2bda-e063-6294a90abff4	2026-04-07	Warnings	Exact identifier application number: M020
Neutrogena MINERAL UV TINT FACE MEDIUM DEEP SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Acupac Packaging, Inc	4ee39bbf-b7d7-8f87-e063-6294a90a2539	2026-04-07	Warnings	Exact identifier application number: M020
BEVERLY HILLS MD SHEER RADIANCE SPF DROPS SUNSCREEN	ZINC OXIDE	Beverly Hills MD, LLC	4ed34743-cc68-501b-e063-6294a90ad396	2026-04-07	Warnings	Exact identifier application number: M020
Nu Colour Bioadaptive BB plus Foundation - Beige	TITANIUM DIOXIDE	NSE Products, Inc.	f74e83fe-41a0-4998-ae53-30ed5af47592	2026-04-07	Warnings	Exact identifier application number: M020
Thinksport SPF 30	ZINC OXIDE	thinkOperations,LLC	33065919-9b4e-4b2b-9306-a706558241c8	2026-04-07	Warnings	Exact identifier application number: M020
Nutricentials Day Dream Protective	HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE	NSE Products, Inc	daca8347-f7e7-4733-bd22-1da7a6076fad	2026-04-06	Warnings	Exact identifier application number: M020
TONEfitSUN Ultra Moisturizing Vegan Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory	4ec58c23-16b1-03bb-e063-6394a90a46c0	2026-04-06	Warnings	Exact identifier application number: M020
Dior Forever Velvet Veil 24H Mattifying Makeup Base Blurring-Smoothing Pore Refining Effect with Sunscreen SPF 15	HOMOSALATE, OCTISALATE, OCTOCRYLENE	Parfums Christian Dior	be36b83f-662d-49c6-a12f-a64e11721d0c	2026-04-06	Warnings	Exact identifier application number: M020
Pure Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Liz Corporation Ltd	4eca5257-6840-2a33-e063-6394a90ade28	2026-04-06	Warnings	Exact identifier application number: M020
Dior Forever Skin Veil 24H Glow Hydrating Base Plumping and Smoothing Effect Hyaluronic Acid with Sunscreen SPF 25	ENSULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Parfums Christian Dior	4a5147f3-4e52-447a-a89c-058aea8a612c	2026-04-06	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