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 177 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ATTITUDE Oceanly Phyto-Sun Tinted Oil SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0e9b0642-53ed-ec94-e063-6394a90aec3d	2025-10-20	Warnings	Exact identifier application number: M020
ATTITUDE Oceanly Phyto-Sun Tinted Cream SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0d977158-8b5d-66ac-e063-6294a90a4d5c	2025-10-20	Warnings	Exact identifier application number: M020
ATTITUDE Oceanly Phyto-Sun Kit SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0eae4b71-60be-9715-e063-6294a90af463	2025-10-20	Warnings	Exact identifier application number: M020
Attitude Oceanly Phyto-Sun Tinted - SPF 15 - Broad Spectrum Sunscreen	ZINC OXIDE	Attitude DBA 9055-7588 Qubec Inc.	9ed70230-980c-474c-9f72-a6be0f355124	2025-10-20	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE OCTISALATE OCTOCRYLENE	Edgewell Personal Care Brands LLC	419b8043-7921-ca77-e063-6394a90a99ba	2025-10-20	Warnings	Exact identifier application number: M020
Illuminizing Blendrops Broad Spectrum SPF 46	HOMOSALATE, OCTISALATE, ZINC OXIDE	Wasatch Product Development, LLC	419c8718-6b9e-3df7-e063-6294a90a1e3b	2025-10-20	Warnings	Exact identifier application number: M020
Sonni SunDay Serum	ZINC OXIDE	Sonni	419d4ada-fe9b-b774-e063-6394a90a3d09	2025-10-20	Warnings	Exact identifier application number: M020
Lip Clear Lysine Plus Coldstick	OCTINOXATE AND OXYBENZONE	Quantum, Inc.	66f84e56-4a5d-4b71-8bd3-79961e7bf4fe	2025-10-20	Warnings	Exact identifier application number: M020
Super Lysine Plus Strawberry Lip Treatment	OCTINOXATE AND OXYBENZONE	Quantum, Inc.	2cafc97f-4cd3-4755-b394-3802c28d4ed5	2025-10-20	Warnings	Exact identifier application number: M020
Super Lysine Plus Tangerine Lip Treatment	OCTINOXATE AND OXYBENZONE	Quantum, Inc.	8a00194e-9e28-4257-82e5-59bc44f7897d	2025-10-20	Warnings	Exact identifier application number: M020
Super Lysine Plus Coldstick	OCTINOXATE AND OXYBENZONE	Quantum, Inc.	c9318a8c-ba3b-4068-84df-110c9005ee1d	2025-10-20	Warnings	Exact identifier application number: M020
Terez Honor Hydro Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	DEWYCREAM INC	418d054b-436f-6aa3-e063-6294a90a0f56	2025-10-19	Warnings	Exact identifier application number: M020
Danahan Moisture Daily Sunscreen Broad Spectrum SPF 50	ENSULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	Cosmocos Co., Ltd	41129799-85ed-2de2-e063-6394a90ab40c	2025-10-17	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	c5a67314-e5b2-4dd6-94e9-39c2f286c346	2025-10-17	Warnings	Exact identifier application number: M020
LION POSE GHOST-BUSTER BROAD SPECTRUM SPF 42 SUNSCREEN	ZINC OXIDE	Lion Pose Inc.	0310407b-fb74-aa8b-e063-6294a90ad841	2025-10-17	Warnings	Exact identifier application number: M020
Thrive Daily Defense Sunscreen Balm SPF30	ZINC OXIDE	Thrive Natural Care, Inc	1266bd05-1971-a7f0-e063-6394a90a089c	2025-10-17	Warnings	Exact identifier application number: M020
AESOP Avail Body Sunscreen Broad Spectrum SPF 50	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Emeis Cosmetics Pty Ltd	2cb40521-94ed-4e76-a4e2-de1c80155bd2	2025-10-17	Warnings	Exact identifier application number: M020
AESOP Avail Facial Sunscreen Broad Spectrum SPF 25	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Emeis Cosmetics Pty Ltd	bff60c2f-0cc6-493b-81a0-ed35e9746146	2025-10-17	Warnings	Exact identifier application number: M020
Mineral Lip Balm Pineapple	ZINC OXIDE	Synchronicity Spa, Inc. DBA Suntegrity	667714f6-38bc-4c94-aacc-24b46e8e59fd	2025-10-17	Warnings	Exact identifier application number: M020
ELEVEN BY VENUS WILLIAMS GAME SET MATCH BODY	ZINC OXIDE	Eco-Chic LLC	dd2fe82e-31e1-1349-e053-2995a90aa409	2025-10-16	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