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 298 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Intensive Age Defying Hydrating Complex SPF 25	HOMOSALATE, OCTINOXATE, OXYBENZONE, AVOBENZONE	June Jacobs Labs, LLC	18f59d9d-1328-d815-e063-6294a90a3801	2024-05-21	Warnings	Exact identifier application number: M020
Advanced Sun Resistance SPF 30	HOMOSALATE, OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE	June Jacobs Labs, LLC	18f879f0-3d5b-0067-e063-6394a90a9db3	2024-05-21	Warnings	Exact identifier application number: M020
Protective Tinted Moisturizer Broad Spectrum Sunscreen SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	June Jacobs Labs LLC	18e1edd9-e39b-c91f-e063-6394a90a32a0	2024-05-20	Warnings	Exact identifier application number: M020
Mineral Sun Defense Moisturizer Broad Spectrum Sunscreen SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	June Jacobs Labs, LLC	18e4c50d-eb91-c269-e063-6394a90a7999	2024-05-20	Warnings	Exact identifier application number: M020
Broad Spectrum SPF 30 Tropical Sunscreen	BROAD SPECTRUM SPF 30 TROPICAL SUNSCREEN	Raining Rose, Inc	18e7fc6b-b40a-f790-e063-6294a90ad0f4	2024-05-20	Warnings	Exact identifier application number: M020
Protectif Untinted	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs	18aa2604-c8f0-ca04-e063-6294a90a1c25	2024-05-17	Warnings	Exact identifier application number: M020
Vacation Shimmer Oil	AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE	Vacation Inc	150cbb23-fcb9-ed6f-e063-6394a90a597c	2024-05-16	Warnings	Exact identifier application number: M020
Babo Botanicals Daily Sheer Fluid Tinted Mineral Sunscreen SPF 50	ZINC OXIDE	Babo Botanicals, Inc.	d66dfcec-ad40-3a0b-e053-2995a90aa006	2024-05-14	Warnings	Exact identifier application number: M020
Babo Botanicals Daily Sheer Fluid Mineral Sunscreen SPF 50	ZINC OXIDE	Babo Botanicals, Inc.	d66c88a1-7684-1043-e053-2a95a90aa2aa	2024-05-14	Warnings	Exact identifier application number: M020
Jack Black	TITANIUM DIOXIDE, ZINC OXIDE	Jack Black L.L.C	181d5bf3-ce91-cb2c-e063-6294a90a51c4	2024-05-10	Warnings	Exact identifier application number: M020
Protectif Fair Tint	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs	181e3f34-c5b2-0976-e063-6394a90a9a78	2024-05-10	Warnings	Exact identifier application number: M020
SABIYA Broad Spectrum SPF-30	ZINC OXIDE	SABIYA, LLC	bc403672-7576-49a6-9a29-4f6cb19af7a4	2024-05-09	Warnings	Exact identifier application number: M020
SABIYA Broad Spectrum SPF-50	ZINC OXIDE	SABIYA, LLC	4264f23f-4f2a-4fd1-ad35-e7d649ee3f5c	2024-05-09	Warnings	Exact identifier application number: M020
Protectif Deep Tint	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs	180b2939-5ae4-88fb-e063-6394a90aad93	2024-05-09	Warnings	Exact identifier application number: M020
UV Daily Deep Tint	OCTINOXATE, ZINC OXIDE SUNSCREEN	CP Skin Health Group, Inc.	c12fa9a4-d7e5-46bf-9bfb-1cbbaa73b450	2024-05-09	Warnings	Exact identifier application number: M020
Chemical Sunscreen SPF50	OCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE SUNSCREEN	Swiss-American CDMO, LLC	50f47495-93aa-4e11-a153-d4c847a36c99	2024-05-08	Warnings	Exact identifier application number: M020
UV Clear Deep Tint	OCTINOXATE, ZINC OXIDE SUNSCREEN	CP Skin Health Group, Inc.	ead07d51-9400-4f0a-8966-7052dfae67bc	2024-05-08	Warnings	Exact identifier application number: M020
Essence Pout Protector SPF 20 Lip Balm	HOMOSALATE, OCTISALATE, ZINC OXIDE	cosnova GmbH	17e483c5-6e47-9a50-e063-6394a90aa604	2024-05-07	Warnings, Adverse reactions	Exact identifier application number: M020
MIRABELLA Broad Spectrum SPF 30 Sunscreen	HOMOSALATE, OCTISALATE, AVOBENZONE	GDM ENTERPRISES LLC	3ac847d5-a75d-4b32-84e1-70e4282c0d72	2024-05-06	Warnings	Exact identifier application number: M020
MELAN SPF-30 Broad Spectrum	AVOBENZONE, HOMOSALATE, OCTISALATE	MELAN INC.	75fcef12-bc33-44a7-acda-77d5d7bca2bc	2024-05-02	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