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 296 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Giorgio Armani Power Fabric Plus Weightless Matte Foundation Broad Spectrum SPF 25 Sunscreen	OCTINOXATE	SICOS ET CIE	3b49a970-653b-4256-b2d3-4e065db63849	2024-06-24	Warnings	Exact identifier application number: M020
Giorgio Armani Power Fabric Plus Weightless Matte Foundation Broad Spectrum SPF 25 Sunscreen	OCTINOXATE	L'Oreal USA Products Inc.	1b851e19-add0-437b-86e4-e88a10a1e774	2024-06-24	Warnings	Exact identifier application number: M020
Exel Clarifying Line SPF 50	OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE	Biocosmetica Exel Argentina SRL	e65a68f6-d1b7-4cbf-a3f8-5cc04036221a	2024-06-23	Warnings	Exact identifier application number: M020
Bitchstix Citrus Orange Broad Spectrum SPF 30 Sunscreen Lip Balm SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Bitchstix, LLC	1b6bf419-554c-86a7-e063-6294a90a5a7e	2024-06-21	Warnings	Exact identifier application number: M020
OS-01 Body SPF 30	ZINC OXIDE	Allure Labs	1b582f4e-553f-a511-e063-6294a90af3c0	2024-06-20	Warnings	Exact identifier application number: M020
Seaweed Bath Co Playful Papaya Kids Sunscreen SPF 50	ZINC OXIDE	The Seaweed Bath Co.	65c9c131-2545-4d88-aa9a-85197b654d74	2024-06-19	Warnings	Exact identifier application number: M020
Protectif Fair Tint	ZINC OXIDE AND TITANIUM DIOXIDE	Derma Research Group Inc.	1a8c8804-1d6b-b5a5-e063-6394a90a1260	2024-06-18	Warnings	Exact identifier application number: M020
EB-5 Super Hydrating Anti-Aging SPF-50	OCTOCRYLENE, ZINC OXIDE, OCTISALATE	LIFE O, INC.	b9521112-d119-4d48-8504-4e46b434f76f	2024-06-17	Warnings	Exact identifier application number: M020
Burts Bees SPF 30 Untinted Lip Balm Beaches and Cream	BURTS BEES SPF 30 UNTINTED LIP BALM BEACHES AND CREAM	Autumn Harp	1ac89261-eeae-567c-e063-6294a90ad45f	2024-06-13	Warnings	Exact identifier application number: M020
Protectif Untinted	ZINC OXIDE AND TITANIUM DIOXIDE	Derma Research Group Inc.	1acd3f09-87f2-75e4-e063-6394a90a0cd9	2024-06-13	Warnings	Exact identifier application number: M020
Mara Clear Skin Mineral Milk Acne Treatment	SALICYLIC ACID	Mara Beauty LLC	3823024e-81b4-4e29-af76-82231e09407c	2024-06-13	Warnings	Exact identifier application number: M020
BOB KIDS SPF 30 Zinc only	ZINC OXIDE	SPF Ventures, LLC	1aae0291-f16f-7840-e063-6394a90a3443	2024-06-12	Warnings	Exact identifier application number: M020
Glossier Invisible Shield SPF 50	GLOSSIER INVISIBLE SHIELD SPF 50	Autumn Harp	1ab39eae-06e9-0e4c-e063-6394a90ad8aa	2024-06-12	Warnings	Exact identifier application number: M020
Thinksport SPF 50	ZINC OXIDE	thinkOperations,LLC	2e83e382-8eb0-40f2-bdca-2db5e184661e	2024-06-10	Warnings	Exact identifier application number: M020
Thinkkids SPF 50	ZINC OXIDE	thinkOperations,LLC	09f9d9bb-c08b-401c-bbf1-640f1c8ec678	2024-06-07	Warnings	Exact identifier application number: M020
NAELI Day Moisturizer Broad Spectrum SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	ALLI LLC	f2cebdc7-c96e-46cf-9b5c-b4965ddd2aec	2024-06-06	Warnings	Exact identifier application number: M020
Youth 3 Activating BB Cream SPF 30 Medium	ZINC OXIDE, TITANIUM DIOXIDE	Shaklee Corporation	ccc80ea4-f270-4fd4-970c-eaa63df936e4	2024-06-06	Warnings	Exact identifier application number: M020
Thinkbaby SPF 50	ZINC OXIDE	thinkOperations,LLC	f2788a1a-daf6-4b7d-8333-585a380ebe57	2024-06-05	Warnings	Exact identifier application number: M020
RMS SUNCOVERUP SUPER TINT SPF 50 ALABASTER	ZINC OXIDE	Rms organics LLC	1a11c884-d6ba-d77f-e063-6394a90a5bd2	2024-06-04	Warnings	Exact identifier application number: M020
toty Solaria Body	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	CHIPICAN LLC	1a121b17-3621-6bc1-e063-6394a90ac9a1	2024-06-04	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