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 212 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TALLOW SUNSCREEN	NON-NANO ZINC OXIDE	FOUNDATION COMMERCE INC	363e38bf-b4b4-dcc4-e063-6294a90a5d2f	2025-05-28	Warnings	Exact identifier application number: M020
CoreTex SunX 50 Facestick	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CoreTex Products Inc	364989ea-c93b-d404-e063-6294a90abd09	2025-05-28	Warnings	Exact identifier application number: M020
Solvaderm Universal Tinted Moisturizer Sunscreen SPF 30	OCTINOXATE, ZINC OXIDE	SOLVADERM LLC	86dbd8c3-e95a-49a8-afe6-ff9d985e28ba	2025-05-27	Warnings	Exact identifier application number: M020
NATUREWELL HYDRASUN LIP BALM SPF30 CITRUS SPRITZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LIP BALM	Port Jervis Laboratories, Inc.	350b4cce-1627-5b8f-e063-6294a90aa6bf	2025-05-26	Warnings	Exact identifier application number: M020
Protect Daily Ritual Mineral Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Melinda Menezes, M.D., Inc.	35ce8307-387b-2b40-e063-6294a90a28bc	2025-05-23		Exact identifier application number: M020
OS-01 FACE SPF BD SPF 30 TINTED MEDIUM/DEEP	ZINC OXIDE	ONESKIN INC.	35d57d3f-376c-2307-e063-6294a90adf51	2025-05-23	Warnings	Exact identifier application number: M020
Oathology Inzincable Lip Balm SPF 35	ZINC OXIDE	SKINOATH LLC	289a5492-af57-42e5-82af-3f1e4b369d68	2025-05-22	Warnings	Exact identifier application number: M020
NAELI Tinted Mineral Moisturizer Sunscreen SPF 50, Light	ZINC OXIDE	ALLI LLC	3cb4459b-1776-414a-b5c4-0ffb9f1df766	2025-05-22	Warnings	Exact identifier application number: M020
NAELI Tinted Mineral Moisturizer Sunscreen SPF 50, Dark	ZINC OXIDE	ALLI LLC	81633684-f9ac-45cb-8a3e-f0c30b229a82	2025-05-22	Warnings	Exact identifier application number: M020
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Melinda Menezes, M.D., Inc.	35bea4f3-c19e-3e2e-e063-6394a90aeb69	2025-05-22		Exact identifier application number: M020
LBEL FOREVER HYDRA LONGWEAR AND HYDRATING FOUNDATION 90H SPF 15 ALMENDRA 230N	OCTINOXATE, ZINC OXIDE	BEL STAR S.A.	35c106b6-9a80-01e3-e063-6294a90abc35	2025-05-22	Warnings	Exact identifier application number: M020
COSRX	AIRY-LIGHT CLEAR SUNCREEN STICK	COSRX inc.	313b1a73-8863-c458-e063-6394a90a01d6	2025-05-20	Warnings	Exact identifier application number: M020
Melan Antioxidant Body Mist Sunscreen SPF 30	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	MELAN INC.	f627b17f-d2dc-47bd-b865-08995995e861	2025-05-20	Warnings	Exact identifier application number: M020
JAFRA BIOLAB FACIAL FLUID BROAD SPECTRUM SPF 50 SUNSCREEN	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Distribuidora Comercial Jafra, S.A. de C.V.	63e078a3-d5df-4458-a745-e306d734e6be	2025-05-20	Warnings	Exact identifier application number: M020
JAFRA BIOLAB DARK SPOT CORRECTOR FACIAL cream BROAD SPECTRUM SPF 30 SUNSCREEN	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Distribuidora Comercial Jafra, S.A. de C.V.	90531e8f-15c6-49ac-96a4-3bdfab2bfd9b	2025-05-20	Warnings	Exact identifier application number: M020
JAFRA BIOLAB SUNSCREENS AND CLEANSER	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Distribuidora Comercial Jafra, S.A. de C.V.	28db9f44-780f-4cd5-940e-3ee779f38247	2025-05-20	Warnings	Exact identifier application number: M020
Mineral Stick Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	IT INTELLIGENT TREATMENT LLC	3595149d-0735-6bea-e063-6394a90a618a	2025-05-20		Exact identifier application number: M020
Mineral Stick Tinted	TITANIUM DIOXIDE, ZINC OXIDE	IT INTELLIGENT TREATMENT LLC	3595735e-c25f-eb48-e063-6294a90aac0f	2025-05-20		Exact identifier application number: M020
Coola Clear California Summers	OCTOCRYLENE AVOBENZONE OCTISALATE HOMOSALATE	COOLA, LLC	358009c4-492d-ac03-e063-6294a90af227	2025-05-19	Warnings	Exact identifier application number: M020
OS-01 FACE SPF BS SPF 30 TINTED DEEP	ZINC OXIDE	ONESKIN INC.	3581f578-e19e-9ace-e063-6294a90acc34	2025-05-19	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