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 310 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lancome Paris Absolue Bx Makeup Broad Spectrum SPF 18 Sunscreen Absolute Replenishing Radiant Makeup Normal to Dry Skin	OCTINOXATE	L'Oreal USA Products Inc	a45fef28-5dde-48b2-b7c0-ede694f4c32b	2023-12-30	Warnings	Exact identifier application number: M020
it cosmetics Bye Bye Foundation Full Coverage Moisturizer Broad Spectrum 50 Plus Sunscreen All Shades	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	34f0c2c9-a5bc-4b25-bfc1-336dcbb353e4	2023-12-30	Warnings	Exact identifier application number: M020
Kiehls Since 1851 Ultra Facial Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	LOreal USA Products Inc	fb9daea3-c249-417c-ad34-3e89f3118559	2023-12-30	Warnings	Exact identifier application number: M020
Kiehls Since 1851 Broad Spectrum SPF 30 Sunscreen Powerful Wrinkle Reducing	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	3f58b258-b954-41f0-93ad-f6c9fe25718d	2023-12-30	Warnings	Exact identifier application number: M020
Kiehls Since 1851 Activated Sun Protector Broad Spectrum SPF 30 Sunscreen Water Resistant 80 MInutes	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE	L'Oreal USA Products Inc	2d2fbd8b-a90f-465a-9bf3-75cd6abdc6d3	2023-12-30	Warnings	Exact identifier application number: M020
Lancome Paris Renergie Lift MultiAction Ultra Firming and Dark Spot Correcting Moisturizer Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	bf0e22df-4043-407f-a930-29595da1bdf6	2023-12-30	Warnings	Exact identifier application number: M020
Kiehls Since 1851 Activated Sun Protector Broad Spectrum SPF 50 Sunscreen Water Resistant 80 MInutes	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE	L'Oreal USA Products Inc	04fd0839-5046-4633-a919-6b7b6bea4f3e	2023-12-30	Warnings	Exact identifier application number: M020
Kiehls Since 1851 Dermatologist Solutions Super Fluid Daily UV Defense Broad Spectrum SPF 50 plus Sunscreen Antipollution Lightweight Formula	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	L'Oreal USA Products Inc.	ed138c48-d542-4522-a23c-1b586aad1127	2023-12-30	Warnings	Exact identifier application number: M020
Kiehls Since 1851 Ultra Facial Moisturizer Broad Spectrum SPF 30 Sunscreen For All Skin Types	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	d1a8c8d2-59d2-4389-9369-5f9b053a956e	2023-12-30	Warnings	Exact identifier application number: M020
Lancome Paris Visionnaire Broad Spectrum SPF 20 Sunscreen Advanced Multi Correcting All Skin Types	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	43041108-6adb-4dd3-a75f-87f5d643c794	2023-12-30	Warnings	Exact identifier application number: M020
Lancome Paris Bienfait MultiVital Eye Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	449a6027-4d0d-40e1-af58-3553071d6fdf	2023-12-30	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm Wintergreen SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	baff2dfe-fd0b-0709-e053-2a95a90a431b	2023-12-29	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm Wintergreen SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	bb013e70-f081-f8f2-e053-2995a90a1981	2023-12-29	Warnings	Exact identifier application number: M020
Loreal Paris Age Perfect Rosy Tone SPF 30 Renew and revive healthy tone Visibly younger-looking skin	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	1c83726b-f8ff-48d5-bf30-bc75e3fb149d	2023-12-29	Warnings	Exact identifier application number: M020
LOreal Paris True Match Lumi Healthy Luminous Makeup Broad Spectrum SPF 20	OCTINOXATE	L'Oreal USA Products Inc	cf39375c-de44-47de-bf15-fce4dfad8c74	2023-12-29	Warnings	Exact identifier application number: M020
Loreal Paris Age Perfect Radiant Serum foundation SPF 50	HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	06a94c28-bfb7-4842-a463-459205477cd8	2023-12-29	Warnings	Exact identifier application number: M020
NUDESCREEN BLUSH TINT SPF 30 - PEACHES N SOL	ZINC OXIDE SUNSCREEN	Bentley Laboratories, LLC	e7c9c914-9972-4b55-a49d-cbc8ce075647	2023-12-29	Warnings	Exact identifier application number: M020
LOREAL PARIS REVITALIFT ANTI WRINKLE FIRMING MOISTURIZER SPF 25	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	8840da10-63cb-47ea-ad46-1ae6df1639e8	2023-12-29	Warnings	Exact identifier application number: M020
NUDESCREEN BLUSH TINT SPF 30 - PINK SUNRISE	ZINC OXIDE SUNSCREEN	Bentley Laboratories, LLC	289fb410-7884-4bc4-a25b-963de1cc3a70	2023-12-29	Warnings	Exact identifier application number: M020
LOreal Paris Infallible ProGlow Broad Spectrum SPF 15 Sunscreen	OCTINOXATE	L'Oreal USA Products Inc	82a6fbba-f0d4-475f-9ba7-615118eed70d	2023-12-29	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